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Trial record 1 of 1 for:    17-0090
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2017 A/H7N9 IIV Revaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738241
Recruitment Status : Completed
First Posted : November 13, 2018
Results First Posted : July 1, 2021
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Avian Influenza
Influenza Immunisation
Interventions Biological: A/H7N9
Drug: AS03
Other: Phosphate Buffered Saline (PBS) diluent
Enrollment 304
Recruitment Details Participants were healthy males and non-pregnant females between 19 and 70 years old, inclusively. They were recruited from the communities at large around the clinical sites. Participants were enrolled between 18DEC2018 and 19MAR2019.
Pre-assignment Details  
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description

Participants will have prior administration of 2013 A/H7N9 IIV with MF59. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine.

Participants will have prior administration of 2013 A/H7N9 IIV with MF59. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.

Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine.

Participants will have prior administration of 2013 A/H7N9 IIV with AS03. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine.

Participants will have prior administration of 2013 A/H7N9 IIV with AS03. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.

Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine.

Participants will have prior administration of 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine.

Participants will have prior administration of 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.

Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine.

Participants will have prior administration of 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine.

Participants will have prior administration of 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.

Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine.

Participants who are A/H7 IIV-Naïve. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine.

Participants who are A/H7 IIV-Naïve. Then, 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages.

Biological: A/H7N9 Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and other components from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).

Drug: AS03 AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.

Other: Phosphate Buffered Saline (PBS) diluent 0.006M PBS diluent for Influenza Virus Vaccine.

Period Title: Overall Study
Started 38 40 24 18 40 44 20 16 29 35
Completed 37 40 24 18 40 44 20 16 28 34
Not Completed 1 0 0 0 0 0 0 0 1 1
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             1
Physician Decision             0             0             0             0             0             0             0             0             1             0
Adverse Event             1             0             0             0             0             0             0             0             0             0
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03 Total
Hide Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 38 40 24 18 40 44 20 16 29 35 304
Hide Baseline Analysis Population Description
The baseline analysis population includes all enrolled participants
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age, Categorical Number Analyzed 38 participants 40 participants 24 participants 18 participants 40 participants 44 participants 20 participants 16 participants 29 participants 35 participants 304 participants
19 - 35 years
9
  23.7%
4
  10.0%
5
  20.8%
1
   5.6%
11
  27.5%
5
  11.4%
5
  25.0%
4
  25.0%
20
  69.0%
19
  54.3%
83
  27.3%
36 - 50 years
14
  36.8%
18
  45.0%
6
  25.0%
6
  33.3%
11
  27.5%
15
  34.1%
3
  15.0%
3
  18.8%
3
  10.3%
10
  28.6%
89
  29.3%
51-70 years
15
  39.5%
18
  45.0%
13
  54.2%
11
  61.1%
18
  45.0%
24
  54.5%
12
  60.0%
9
  56.3%
6
  20.7%
6
  17.1%
132
  43.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 24 participants 18 participants 40 participants 44 participants 20 participants 16 participants 29 participants 35 participants 304 participants
Female
18
  47.4%
21
  52.5%
11
  45.8%
16
  88.9%
26
  65.0%
25
  56.8%
11
  55.0%
13
  81.3%
16
  55.2%
15
  42.9%
172
  56.6%
Male
20
  52.6%
19
  47.5%
13
  54.2%
2
  11.1%
14
  35.0%
19
  43.2%
9
  45.0%
3
  18.8%
13
  44.8%
20
  57.1%
132
  43.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 24 participants 18 participants 40 participants 44 participants 20 participants 16 participants 29 participants 35 participants 304 participants
Hispanic or Latino
1
   2.6%
2
   5.0%
3
  12.5%
0
   0.0%
2
   5.0%
3
   6.8%
0
   0.0%
2
  12.5%
4
  13.8%
4
  11.4%
21
   6.9%
Not Hispanic or Latino
37
  97.4%
38
  95.0%
21
  87.5%
18
 100.0%
38
  95.0%
41
  93.2%
20
 100.0%
14
  87.5%
25
  86.2%
31
  88.6%
283
  93.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 24 participants 18 participants 40 participants 44 participants 20 participants 16 participants 29 participants 35 participants 304 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
1
   2.9%
2
   0.7%
Asian
0
   0.0%
1
   2.5%
1
   4.2%
0
   0.0%
1
   2.5%
2
   4.5%
1
   5.0%
1
   6.3%
4
  13.8%
2
   5.7%
13
   4.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  15.8%
3
   7.5%
1
   4.2%
2
  11.1%
2
   5.0%
4
   9.1%
0
   0.0%
3
  18.8%
10
  34.5%
11
  31.4%
42
  13.8%
White
30
  78.9%
35
  87.5%
22
  91.7%
13
  72.2%
34
  85.0%
34
  77.3%
18
  90.0%
11
  68.8%
12
  41.4%
20
  57.1%
229
  75.3%
More than one race
2
   5.3%
1
   2.5%
0
   0.0%
2
  11.1%
2
   5.0%
4
   9.1%
1
   5.0%
0
   0.0%
3
  10.3%
1
   2.9%
16
   5.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
1
   2.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 40 participants 24 participants 18 participants 40 participants 44 participants 20 participants 16 participants 29 participants 35 participants 304 participants
38 40 24 18 40 44 20 16 29 35 304
Body Mass Index (BMI)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 24 participants 18 participants 40 participants 44 participants 20 participants 16 participants 29 participants 35 participants 304 participants
< 30 kg/m^2
25
  65.8%
26
  65.0%
16
  66.7%
13
  72.2%
29
  72.5%
28
  63.6%
15
  75.0%
8
  50.0%
17
  58.6%
26
  74.3%
203
  66.8%
>= 30 kg/m^2
13
  34.2%
14
  35.0%
8
  33.3%
5
  27.8%
11
  27.5%
16
  36.4%
5
  25.0%
8
  50.0%
12
  41.4%
9
  25.7%
101
  33.2%
Prior Seasonal Influenza Vaccination  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 24 participants 18 participants 40 participants 44 participants 20 participants 16 participants 29 participants 35 participants 304 participants
2017-2018 and 2018-2019
30
  78.9%
32
  80.0%
17
  70.8%
13
  72.2%
31
  77.5%
30
  68.2%
16
  80.0%
10
  62.5%
13
  44.8%
14
  40.0%
206
  67.8%
2017-2018 only
0
   0.0%
2
   5.0%
3
  12.5%
1
   5.6%
2
   5.0%
2
   4.5%
1
   5.0%
2
  12.5%
6
  20.7%
7
  20.0%
26
   8.6%
2018-2019 only
3
   7.9%
3
   7.5%
0
   0.0%
1
   5.6%
2
   5.0%
6
  13.6%
0
   0.0%
3
  18.8%
4
  13.8%
6
  17.1%
28
   9.2%
Neither
5
  13.2%
3
   7.5%
4
  16.7%
3
  16.7%
5
  12.5%
6
  13.6%
3
  15.0%
1
   6.3%
6
  20.7%
8
  22.9%
44
  14.5%
1.Primary Outcome
Title Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: titer
22.7
(14.5 to 35.8)
116.1
(82.1 to 164.2)
77.7
(44.7 to 135.1)
190.3
(100.9 to 358.9)
10.9
(7.5 to 15.9)
31.7
(21.3 to 47.0)
33.1
(17.0 to 64.1)
180.9
(100.5 to 325.7)
6.6
(4.9 to 8.9)
8.3
(6.0 to 11.5)
2.Primary Outcome
Title Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: titer
64.3
(39.3 to 105.2)
367.6
(251.9 to 536.4)
204.5
(112.6 to 371.6)
870.9
(623.7 to 1216.0)
28.6
(17.8 to 46.1)
72.2
(47.3 to 110.2)
115.1
(54.0 to 245.2)
562.0
(316.0 to 999.4)
5.8
(4.9 to 6.9)
10.8
(7.7 to 15.1)
3.Primary Outcome
Title Number of Participants Reporting Serious Adverse Events (SAEs)
Hide Description SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect.
Time Frame Day 1 through Day 366
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Hide Analysis Population Description
The safety population includes all participants who received study vaccination.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 38 40 24 18 40 44 20 16 29 35
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   2.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.4%
0
   0.0%
4.Primary Outcome
Title Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs)
Hide Description Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10^3/µL or below or 416 x10^3/µL or greater; or WBC or 3.9 x10^3/µL or lower or 10.6 x10^3/µL or higher.
Time Frame Day 1 to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants who received study vaccination. Participants with at least one lab result reported for Day 8 were included for this outcome measure.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 38 40 24 18 40 44 20 16 29 35
Measure Type: Count of Participants
Unit of Measure: Participants
ALT Number Analyzed 37 participants 40 participants 24 participants 18 participants 40 participants 43 participants 20 participants 16 participants 28 participants 34 participants
1
   2.7%
0
   0.0%
3
  12.5%
0
   0.0%
3
   7.5%
0
   0.0%
1
   5.0%
3
  18.8%
0
   0.0%
1
   2.9%
Bilirubin Number Analyzed 37 participants 40 participants 24 participants 18 participants 40 participants 43 participants 20 participants 16 participants 28 participants 34 participants
0
   0.0%
0
   0.0%
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.6%
0
   0.0%
Creatinine Number Analyzed 37 participants 40 participants 24 participants 18 participants 40 participants 43 participants 20 participants 16 participants 28 participants 34 participants
0
   0.0%
1
   2.5%
0
   0.0%
0
   0.0%
2
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
Hemoglobin Number Analyzed 37 participants 40 participants 24 participants 17 participants 39 participants 41 participants 20 participants 16 participants 28 participants 35 participants
2
   5.4%
0
   0.0%
0
   0.0%
1
   5.9%
2
   5.1%
0
   0.0%
0
   0.0%
1
   6.3%
1
   3.6%
3
   8.6%
Platelets Number Analyzed 37 participants 40 participants 24 participants 17 participants 39 participants 41 participants 20 participants 16 participants 28 participants 35 participants
2
   5.4%
0
   0.0%
1
   4.2%
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.7%
WBC Number Analyzed 37 participants 40 participants 24 participants 17 participants 39 participants 41 participants 20 participants 16 participants 28 participants 35 participants
3
   8.1%
2
   5.0%
2
   8.3%
0
   0.0%
3
   7.7%
3
   7.3%
0
   0.0%
1
   6.3%
1
   3.6%
3
   8.6%
5.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site Reactogenicity Events
Hide Description Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value >0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value >0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value >0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Time Frame Day 1 through Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants who received study vaccination.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 38 40 24 18 40 44 20 16 29 35
Measure Type: Count of Participants
Unit of Measure: Participants
11
  28.9%
35
  87.5%
5
  20.8%
16
  88.9%
11
  27.5%
38
  86.4%
3
  15.0%
14
  87.5%
12
  41.4%
30
  85.7%
6.Primary Outcome
Title Number of Participants Reporting Solicited Systemic Reactogenicity Events
Hide Description Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Time Frame Day 1 through Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants who received study vaccination.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 38 40 24 18 40 44 20 16 29 35
Measure Type: Count of Participants
Unit of Measure: Participants
12
  31.6%
24
  60.0%
8
  33.3%
6
  33.3%
16
  40.0%
16
  36.4%
7
  35.0%
10
  62.5%
10
  34.5%
20
  57.1%
7.Primary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
49
(31 to 66)
88
(73 to 96)
75
(53 to 90)
89
(65 to 99)
20
(9 to 36)
59
(43 to 74)
55
(32 to 77)
94
(70 to 100)
11
(2 to 28)
9
(2 to 23)
8.Primary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
69
(51 to 83)
98
(87 to 100)
92
(73 to 99)
100
(81 to 100)
43
(27 to 59)
66
(50 to 80)
75
(51 to 91)
94
(70 to 100)
4
(0 to 18)
3
(0 to 15)
9.Primary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus
Hide Description Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
49
(31 to 66)
88
(73 to 96)
75
(53 to 90)
83
(59 to 96)
20
(9 to 36)
52
(37 to 68)
55
(32 to 77)
88
(62 to 98)
7
(1 to 24)
6
(1 to 19)
10.Primary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2017 Influenza A/H7N9 Study Vaccine Virus
Hide Description Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
69
(51 to 83)
98
(87 to 100)
83
(63 to 95)
100
(81 to 100)
43
(27 to 59)
64
(48 to 78)
75
(51 to 91)
94
(70 to 100)
4
(0 to 18)
3
(0 to 15)
11.Secondary Outcome
Title Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 8 Against the 2017 Influenza A/ H7N9 Vaccine Virus
Hide Description Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 7 days post study vaccination (Day 8).
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 36 40 24 18 40 44 20 16 28 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
13.9
(9.3 to 20.7)
54.2
(33.4 to 87.7)
36.2
(21.3 to 61.3)
113.9
(62.2 to 208.5)
9.9
(7.0 to 14.0)
18.1
(12.1 to 27.2)
16.8
(9.2 to 30.8)
91.8
(46.8 to 180.0)
6.1
(4.6 to 8.1)
6.1
(4.8 to 7.7)
12.Secondary Outcome
Title Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 181 Against the 2017 Influenza A/ H7N9 Vaccine Virus
Hide Description Blood was collected for HAI assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 180 days post study vaccination (Day 181).
Time Frame Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
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2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 27 34
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
10.5
(7.2 to 15.2)
40.0
(25.6 to 62.4)
35.1
(19.2 to 64.2)
79.5
(40.6 to 155.6)
9.9
(6.4 to 15.3)
11.5
(8.3 to 15.9)
9.5
(6.3 to 14.4)
42.7
(23.3 to 78.1)
5.1
(4.9 to 5.3)
6.2
(4.8 to 7.9)
13.Secondary Outcome
Title Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 7 days post study vaccination (Day 8).
Time Frame Day 8
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Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
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2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 36 40 24 18 40 44 20 16 28 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
34.3
(21.4 to 55.1)
153.2
(91.6 to 256.1)
108.9
(62.4 to 189.8)
482.5
(270.5 to 860.9)
17.5
(12.1 to 25.2)
31.4
(21.0 to 47.0)
45.2
(20.8 to 97.9)
320.0
(166.4 to 615.3)
5.9
(4.8 to 7.3)
7.0
(5.0 to 9.9)
14.Secondary Outcome
Title Geometric Mean Titers (GMT) of Serum Neutralizing (Neut) Antibodies on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for Neutralizing assay which was conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 180 days post study vaccination (Day 181).
Time Frame Day 181
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Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
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2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 19 16 27 34
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
24.1
(15.4 to 37.5)
105.3
(65.8 to 168.2)
73.4
(38.0 to 141.6)
296.3
(147.4 to 595.6)
14.3
(9.5 to 21.4)
17.0
(12.2 to 23.9)
34.6
(15.2 to 78.4)
110.7
(56.1 to 218.4)
5.4
(4.9 to 5.9)
10.2
(7.8 to 13.4)
15.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Hide Description Blood was collected for HAI assay which was conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
18.7
(12.2 to 28.5)
92.7
(62.4 to 137.6)
62.6
(35.3 to 111.0)
166.3
(87.5 to 315.9)
9.0
(6.5 to 12.6)
21.0
(14.6 to 30.0)
27.3
(14.5 to 51.4)
146.7
(80.1 to 268.7)
5.3
(4.8 to 5.9)
6.1
(4.8 to 7.8)
16.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Hide Description Blood was collected for Neutralizing assay which was conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
98.5
(59.8 to 162.2)
515.4
(367.1 to 723.5)
329.4
(192.5 to 563.6)
1015.9
(785.2 to 1314.5)
39.3
(23.6 to 65.5)
102.1
(64.9 to 160.8)
171.5
(82.6 to 356.0)
744.8
(449.7 to 1233.5)
7.0
(5.1 to 9.5)
10.1
(7.2 to 14.1)
17.Secondary Outcome
Title Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
Hide Description Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) throughout the duration of the study.
Time Frame Day 1 through Day 366
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants who received study vaccination.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 38 40 24 18 40 44 20 16 29 35
Measure Type: Count of Participants
Unit of Measure: Participants
MAAE
5
  13.2%
8
  20.0%
5
  20.8%
6
  33.3%
13
  32.5%
7
  15.9%
8
  40.0%
4
  25.0%
10
  34.5%
3
   8.6%
NOCMC
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
2
   4.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
PIMMC
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title Number of Participants Reporting Unsolicited Non-serious AEs
Hide Description Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through 21 days after study vaccination.
Time Frame Day 1 through Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants who received study vaccination.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 38 40 24 18 40 44 20 16 29 35
Measure Type: Count of Participants
Unit of Measure: Participants
9
  23.7%
10
  25.0%
3
  12.5%
4
  22.2%
15
  37.5%
10
  22.7%
7
  35.0%
5
  31.3%
8
  27.6%
7
  20.0%
19.Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 7 days post second vaccination (Day 8).
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 36 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28
(14 to 45)
65
(48 to 79)
63
(41 to 81)
83
(59 to 96)
18
(7 to 33)
41
(26 to 57)
35
(15 to 59)
81
(54 to 96)
7
(1 to 24)
6
(1 to 19)
20.Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 180 days post second vaccination (Day 181).
Time Frame Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 27 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20
(8 to 37)
55
(38 to 71)
54
(33 to 74)
78
(52 to 94)
18
(7 to 33)
25
(13 to 40)
20
(6 to 44)
56
(30 to 80)
0
(0 to 13)
6
(1 to 20)
21.Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 7 days post study vaccination (Day 8).
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 36 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53
(35 to 70)
80
(64 to 91)
79
(58 to 93)
100
(81 to 100)
33
(19 to 49)
48
(32 to 63)
55
(32 to 77)
94
(70 to 100)
4
(0 to 18)
9
(2 to 23)
22.Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 180 days post study vaccination (Day 181).
Time Frame Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 19 16 27 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31
(17 to 49)
75
(59 to 87)
67
(45 to 84)
94
(73 to 100)
23
(11 to 38)
32
(19 to 48)
42
(20 to 67)
88
(62 to 98)
0
(0 to 13)
9
(2 to 24)
23.Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. Day 8 is 7 days post study vaccination.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 36 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28
(14 to 45)
60
(43 to 75)
58
(37 to 78)
83
(59 to 96)
18
(7 to 33)
34
(20 to 50)
35
(15 to 59)
75
(48 to 93)
4
(0 to 18)
3
(0 to 15)
24.Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. Day 181 is 180 days post study vaccination.
Time Frame Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 27 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20
(8 to 37)
53
(36 to 68)
50
(29 to 71)
72
(47 to 90)
18
(7 to 33)
18
(8 to 33)
20
(6 to 44)
50
(25 to 75)
0
(0 to 13)
3
(0 to 15)
25.Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 8 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 7 days after study vaccination is Day 8.
Time Frame Day 8
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Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 36 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53
(35 to 70)
80
(64 to 91)
75
(53 to 90)
100
(81 to 100)
33
(19 to 49)
48
(32 to 63)
55
(32 to 77)
88
(62 to 98)
4
(0 to 18)
9
(2 to 23)
26.Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 181 Against the 2017 Influenza A/H7N9 Vaccine Virus
Hide Description Blood was collected for the Neutralizing assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 180 days after study vaccination is Day 181.
Time Frame Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 19 16 27 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31
(17 to 49)
73
(56 to 85)
63
(41 to 81)
94
(73 to 100)
23
(11 to 38)
32
(19 to 48)
42
(20 to 67)
88
(62 to 98)
0
(0 to 13)
9
(2 to 24)
27.Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Hide Description Blood was collected for the HAI assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with HAI titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post second vaccination (Day 22).
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34
(19 to 52)
85
(70 to 94)
75
(53 to 90)
94
(73 to 100)
15
(6 to 30)
45
(30 to 61)
55
(32 to 77)
94
(70 to 100)
0
(0 to 12)
3
(0 to 15)
28.Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Titer of 1:40 or Greater on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Hide Description Blood was collected for the Neutralizing assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The percentage of participants with Neut titer >= 1:40 was calculated for each study arm and stratum from the available results at 21 days post study vaccination (Day 22).
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74
(57 to 88)
98
(87 to 100)
96
(79 to 100)
100
(81 to 100)
50
(34 to 66)
84
(70 to 93)
90
(68 to 99)
100
(79 to 100)
4
(0 to 18)
6
(1 to 19)
29.Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Hide Description Blood was collected for the HAI assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. Day 22 is 21 days post study vaccination.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34
(19 to 52)
85
(70 to 94)
75
(53 to 90)
89
(65 to 99)
15
(6 to 30)
45
(30 to 61)
55
(32 to 77)
94
(70 to 100)
0
(0 to 12)
3
(0 to 15)
30.Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibody Seroconversion on Day 22 Against the 2013 Influenza A/H7N9 Vaccine Virus (Priming Vaccine Virus)
Hide Description Blood was collected for the Neutralizing assay conducted with the 2013 H7N9 priming vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as Neut pre-vaccination titer <1:10 and post-vaccination titer >= 1:40 or pre-vaccination titer >= 1:10 and minimum 4-fold rise in post-vaccination antibody titer. 21 days after study vaccination is Day 22.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description:
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1.
3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
Overall Number of Participants Analyzed 35 40 24 18 40 44 20 16 28 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74
(57 to 88)
98
(87 to 100)
96
(79 to 100)
100
(81 to 100)
50
(34 to 66)
84
(70 to 93)
90
(68 to 99)
100
(79 to 100)
4
(0 to 18)
3
(0 to 15)
Time Frame Solicited events and clinical safety laboratory AEs were collected from the time of study vaccination through 7 days after study vaccination. Unsolicited, non-serious AEs were collected from the time of study vaccination through approximately 21 days after study vaccination. SAEs, MAAEs, including NOCMCs and PIMMCs were collected from the time of study vaccination through approximately 12 months after study vaccination
Adverse Event Reporting Description AEs were defined according to ICH E6. Any medical condition present at the time of screening was considered baseline and was not reported as an AE. If the severity of any pre-existing medical condition increased, it was recorded as an AE.
 
Arm/Group Title 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Hide Arm/Group Description 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with MF59. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV with AS03. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV 15 mcg or 45 mcg unadjuvanted. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 2013 A/H7N9 IIV + MF59 or AS03 (1st) then 2013 A/H7N9 IIV 15 mcg (2nd). 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1. 3.75 mcg Hemagglutinin (HA) per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + AS03 adjuvant administered intramuscularly on Day 1.
All-Cause Mortality
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)      0/40 (0.00%)      0/24 (0.00%)      0/18 (0.00%)      0/40 (0.00%)      0/44 (0.00%)      0/20 (0.00%)      0/16 (0.00%)      0/29 (0.00%)      0/35 (0.00%)    
Hide Serious Adverse Events
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      1/40 (2.50%)      0/24 (0.00%)      0/18 (0.00%)      0/40 (0.00%)      0/44 (0.00%)      0/20 (0.00%)      0/16 (0.00%)      1/29 (3.45%)      0/35 (0.00%)    
General disorders                     
Chest Pain * 1  0/38 (0.00%)  0 1/40 (2.50%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Infections and infestations                     
Sepsis * 1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 1/29 (3.45%)  1 0/35 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV 2013 A/H7N9 IIV+MF59|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV 2013 A/H7N9 IIV+AS03|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV|2017 A/H7N9 IIV 2013 A/H7N9 IIV|2017 A/H7N9 IIV+AS03 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV 2013 A/H7N9 IIV + MF59 or AS03 Then 2013 A/H7N9 IIV |2017 A/H7N9 IIV+AS03 A/H7 IIV Naïve |2017 A/H7N9 IIV A/H7 IIV Naïve |2017 A/H7N9 IIV+AS03
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/38 (65.79%)      37/40 (92.50%)      12/24 (50.00%)      16/18 (88.89%)      29/40 (72.50%)      40/44 (90.91%)      13/20 (65.00%)      15/16 (93.75%)      19/29 (65.52%)      34/35 (97.14%)    
Eye disorders                     
Ocular Hyperaemia  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Swelling of Eyelid  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Gastrointestinal disorders                     
Diarrhoea  1  1/38 (2.63%)  1 1/40 (2.50%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 2/44 (4.55%)  2 2/20 (10.00%)  2 1/16 (6.25%)  1 0/29 (0.00%)  0 2/35 (5.71%)  2
Nausea  1  1/38 (2.63%)  1 0/40 (0.00%)  0 2/24 (8.33%)  2 0/18 (0.00%)  0 2/40 (5.00%)  2 3/44 (6.82%)  3 0/20 (0.00%)  0 4/16 (25.00%)  4 1/29 (3.45%)  1 2/35 (5.71%)  2
Vomiting  1  1/38 (2.63%)  1 1/40 (2.50%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 1/16 (6.25%)  1 1/29 (3.45%)  1 0/35 (0.00%)  0
General disorders                     
Fatigue  1  7/38 (18.42%)  7 15/40 (37.50%)  15 3/24 (12.50%)  3 2/18 (11.11%)  2 11/40 (27.50%)  11 9/44 (20.45%)  9 5/20 (25.00%)  5 6/16 (37.50%)  7 7/29 (24.14%)  7 10/35 (28.57%)  10
Feeling Hot  1  2/38 (5.26%)  2 4/40 (10.00%)  4 2/24 (8.33%)  2 2/18 (11.11%)  2 3/40 (7.50%)  3 3/44 (6.82%)  3 2/20 (10.00%)  2 1/16 (6.25%)  1 3/29 (10.34%)  3 5/35 (14.29%)  5
Influenza Like Illness  1  0/38 (0.00%)  0 1/40 (2.50%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 1/16 (6.25%)  1 1/29 (3.45%)  1 0/35 (0.00%)  0
Injection Site Erythema  1  5/38 (13.16%)  5 10/40 (25.00%)  10 3/24 (12.50%)  3 4/18 (22.22%)  4 5/40 (12.50%)  5 10/44 (22.73%)  10 1/20 (5.00%)  1 5/16 (31.25%)  5 8/29 (27.59%)  8 7/35 (20.00%)  7
Injection Site Haemorrhage  1  1/38 (2.63%)  1 2/40 (5.00%)  2 2/24 (8.33%)  2 2/18 (11.11%)  2 0/40 (0.00%)  0 6/44 (13.64%)  6 0/20 (0.00%)  0 2/16 (12.50%)  2 1/29 (3.45%)  1 4/35 (11.43%)  4
Injection Site Induration  1  1/38 (2.63%)  1 7/40 (17.50%)  7 1/24 (4.17%)  1 4/18 (22.22%)  4 2/40 (5.00%)  2 7/44 (15.91%)  7 1/20 (5.00%)  1 3/16 (18.75%)  3 2/29 (6.90%)  2 8/35 (22.86%)  8
Injection Site Pain  1  0/38 (0.00%)  0 22/40 (55.00%)  22 0/24 (0.00%)  0 8/18 (44.44%)  9 2/40 (5.00%)  2 18/44 (40.91%)  18 1/20 (5.00%)  1 13/16 (81.25%)  13 3/29 (10.34%)  3 17/35 (48.57%)  17
Injection Site Pain (Tenderness)  1  7/38 (18.42%)  7 31/40 (77.50%)  31 1/24 (4.17%)  1 14/18 (77.78%)  14 6/40 (15.00%)  6 34/44 (77.27%)  34 1/20 (5.00%)  1 13/16 (81.25%)  13 4/29 (13.79%)  4 28/35 (80.00%)  28
Injection Site Pruritus  1  0/38 (0.00%)  0 3/40 (7.50%)  3 0/24 (0.00%)  0 2/18 (11.11%)  2 0/40 (0.00%)  0 1/44 (2.27%)  1 0/20 (0.00%)  0 2/16 (12.50%)  2 0/29 (0.00%)  0 1/35 (2.86%)  1
Malaise  1  4/38 (10.53%)  4 9/40 (22.50%)  9 3/24 (12.50%)  3 2/18 (11.11%)  2 8/40 (20.00%)  9 6/44 (13.64%)  6 2/20 (10.00%)  2 3/16 (18.75%)  3 3/29 (10.34%)  3 5/35 (14.29%)  5
Pyrexia  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 1/40 (2.50%)  1 0/44 (0.00%)  0 0/20 (0.00%)  0 1/16 (6.25%)  1 0/29 (0.00%)  0 1/35 (2.86%)  1
Vaccination Site Lymphadenopathy  1  0/38 (0.00%)  0 1/40 (2.50%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 1/16 (6.25%)  1 0/29 (0.00%)  0 0/35 (0.00%)  0
Infections and infestations                     
Bronchitis  1  0/38 (0.00%)  0 1/40 (2.50%)  1 0/24 (0.00%)  0 1/18 (5.56%)  1 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Influenza  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 1/16 (6.25%)  1 1/29 (3.45%)  1 0/35 (0.00%)  0
Nasopharyngitis  1  1/38 (2.63%)  1 1/40 (2.50%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0 2/40 (5.00%)  3 2/44 (4.55%)  2 1/20 (5.00%)  1 0/16 (0.00%)  0 1/29 (3.45%)  1 0/35 (0.00%)  0
Respiratory Tract Infection  1  1/38 (2.63%)  1 1/40 (2.50%)  1 1/24 (4.17%)  1 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 1/16 (6.25%)  1 1/29 (3.45%)  1 0/35 (0.00%)  0
Sinusitis  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 1/29 (3.45%)  1 0/35 (0.00%)  0
Upper Respiratory Tract Infection  1  2/38 (5.26%)  2 1/40 (2.50%)  2 0/24 (0.00%)  0 2/18 (11.11%)  2 4/40 (10.00%)  4 2/44 (4.55%)  3 0/20 (0.00%)  0 1/16 (6.25%)  1 1/29 (3.45%)  1 1/35 (2.86%)  1
Injury, poisoning and procedural complications                     
Chest Injury  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Contusion  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 1/29 (3.45%)  1 0/35 (0.00%)  0
Fibula Fracture  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 1/16 (6.25%)  1 0/29 (0.00%)  0 0/35 (0.00%)  0
Skin Laceration  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Investigations                     
Alanine Aminotransferase Increased  1  1/38 (2.63%)  2 0/40 (0.00%)  0 3/24 (12.50%)  3 0/18 (0.00%)  0 3/40 (7.50%)  5 0/44 (0.00%)  0 1/20 (5.00%)  1 3/16 (18.75%)  4 0/29 (0.00%)  0 1/35 (2.86%)  1
Blood Creatinine Increased  1  0/38 (0.00%)  0 1/40 (2.50%)  2 0/24 (0.00%)  0 0/18 (0.00%)  0 2/40 (5.00%)  3 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 0/29 (0.00%)  0 1/35 (2.86%)  1
Hemoglobin Decreased  1  2/38 (5.26%)  2 0/40 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 2/40 (5.00%)  2 0/44 (0.00%)  0 0/20 (0.00%)  0 1/16 (6.25%)  1 1/29 (3.45%)  1 3/35 (8.57%)  4
Platelet Count Increased  1  1/38 (2.63%)  1 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 0/29 (0.00%)  0 2/35 (5.71%)  3
White Blood Cell Count Decreased  1  3/38 (7.89%)  3 1/40 (2.50%)  1 1/24 (4.17%)  1 0/18 (0.00%)  0 4/40 (10.00%)  5 3/44 (6.82%)  3 0/20 (0.00%)  0 1/16 (6.25%)  1 1/29 (3.45%)  1 2/35 (5.71%)  2
Metabolism and nutrition disorders                     
Decreased Appetite  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 1/16 (6.25%)  1 0/29 (0.00%)  0 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders                     
Arthralgia  1  4/38 (10.53%)  4 2/40 (5.00%)  2 0/24 (0.00%)  0 2/18 (11.11%)  2 1/40 (2.50%)  1 2/44 (4.55%)  2 4/20 (20.00%)  4 0/16 (0.00%)  0 1/29 (3.45%)  1 4/35 (11.43%)  4
Back Pain  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 1/40 (2.50%)  1 1/44 (2.27%)  1 1/20 (5.00%)  1 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Intervertebral Disc Protrusion  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Myalgia  1  4/38 (10.53%)  4 11/40 (27.50%)  11 0/24 (0.00%)  0 1/18 (5.56%)  1 1/40 (2.50%)  1 8/44 (18.18%)  8 5/20 (25.00%)  5 2/16 (12.50%)  2 4/29 (13.79%)  4 9/35 (25.71%)  9
Osteoporosis  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Pain in Extremity  1  0/38 (0.00%)  0 1/40 (2.50%)  2 1/24 (4.17%)  1 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 2/20 (10.00%)  2 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Rotator Cuff Syndrome  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 1/40 (2.50%)  1 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Nervous system disorders                     
Dizziness  1  1/38 (2.63%)  1 0/40 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Headache  1  8/38 (21.05%)  8 11/40 (27.50%)  11 6/24 (25.00%)  6 4/18 (22.22%)  4 11/40 (27.50%)  12 8/44 (18.18%)  8 2/20 (10.00%)  2 7/16 (43.75%)  7 6/29 (20.69%)  6 9/35 (25.71%)  9
Psychiatric disorders                     
Insomnia  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 1/44 (2.27%)  1 0/20 (0.00%)  0 2/16 (12.50%)  2 0/29 (0.00%)  0 0/35 (0.00%)  0
Renal and urinary disorders                     
Nephrolithiasis  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Reproductive system and breast disorders                     
Menopausal Symptoms  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Asthma  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Cough  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 0/40 (0.00%)  0 0/44 (0.00%)  0 0/20 (0.00%)  0 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Oropharyngeal Pain  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 0/40 (0.00%)  0 0/44 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
Surgical and medical procedures                     
Bone Lesion Excision  1  0/38 (0.00%)  0 0/40 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 0/40 (0.00%)  0 0/44 (0.00%)  0 1/20 (5.00%)  1 0/16 (0.00%)  0 0/29 (0.00%)  0 0/35 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hana El Sahly, MD, FIDSA
Organization: Baylor College of Medicine
Phone: 713-798-2058
EMail: hana.elsahly@bcm.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03738241    
Other Study ID Numbers: 17-0090
HHSN272201300015I
First Submitted: November 8, 2018
First Posted: November 13, 2018
Results First Submitted: June 10, 2021
Results First Posted: July 1, 2021
Last Update Posted: July 30, 2021