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Trial record 98 of 112 for:    mf59

A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age

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: NCT02839330
Recruitment Status : Completed
First Posted : July 20, 2016
Results First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
Seqirus

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Avian Influenza
Interventions Biological: aH5N1c
Biological: Placebo
Enrollment 3196
Recruitment Details This study was conducted at 26 centers in the USA.
Pre-assignment Details All enrolled subjects were included in the study. A total of 5 subjects were enrolled and randomized in error by sites. These subjects were deemed screen or randomization failures due to violation of the inclusion and/or exclusion criteria. Therefore, of the 3196 subjects enrolled in the study 3191 subjects were vaccinated.
Arm/Group Title Group A: aH5N1c Lot #1 Group B: aH5N1c Lot #2 Group C: aH5N1c Lot #3 Group D: Placebo
Hide Arm/Group Description aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22) aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22) aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22) Placebo; receive 2 doses (on Day 1 and Day 22)
Period Title: Overall Study
Started [1] 804 799 795 798
Exposed 804 797 793 797
Completed 746 741 747 747
Not Completed 58 58 48 51
Reason Not Completed
Adverse Event             0             1             2             2
Death             4             6             1             1
Withdrawal by Subject             27             19             11             13
Lost to Follow-up             22             27             29             25
Administrative Reason             0             0             0             1
Protocol Violation             1             2             2             3
Other reason, not specified             4             3             3             6
[1]
as randomized population
Arm/Group Title Group A: aH5N1c Lot #1 Group B: aH5N1c Lot #2 Group C: aH5N1c Lot #3 Group D: Placebo Total
Hide Arm/Group Description aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22) aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22) aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22) Placebo; receive 2 doses (on Day 1 and Day 22) Total of all reporting groups
Overall Number of Baseline Participants 804 799 795 798 3196
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 804 participants 799 participants 795 participants 798 participants 3196 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
403
  50.1%
399
  49.9%
397
  49.9%
398
  49.9%
1597
  50.0%
>=65 years
401
  49.9%
400
  50.1%
398
  50.1%
400
  50.1%
1599
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 804 participants 799 participants 795 participants 798 participants 3196 participants
58.1  (17.67) 57.5  (17.83) 57.5  (18.24) 57.7  (18.29) 57.7  (18.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 804 participants 799 participants 795 participants 798 participants 3196 participants
Female
444
  55.2%
434
  54.3%
447
  56.2%
438
  54.9%
1763
  55.2%
Male
360
  44.8%
365
  45.7%
348
  43.8%
360
  45.1%
1433
  44.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 804 participants 799 participants 795 participants 798 participants 3196 participants
Hispanic or Latino
53
   6.6%
61
   7.6%
64
   8.1%
55
   6.9%
233
   7.3%
Not Hispanic or Latino
746
  92.8%
729
  91.2%
721
  90.7%
732
  91.7%
2928
  91.6%
Unknown or Not Reported
5
   0.6%
9
   1.1%
10
   1.3%
11
   1.4%
35
   1.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 804 participants 799 participants 795 participants 798 participants 3196 participants
American Indian or Alaska Native
6
   0.7%
4
   0.5%
5
   0.6%
3
   0.4%
18
   0.6%
Asian
12
   1.5%
7
   0.9%
9
   1.1%
7
   0.9%
35
   1.1%
Native Hawaiian or Other Pacific Islander
3
   0.4%
2
   0.3%
1
   0.1%
4
   0.5%
10
   0.3%
Black or African American
110
  13.7%
102
  12.8%
104
  13.1%
112
  14.0%
428
  13.4%
White
668
  83.1%
679
  85.0%
674
  84.8%
665
  83.3%
2686
  84.0%
More than one race NA [1]  NA [1]  NA [1]  NA [1]  NA [2] 
Unknown or Not Reported
5
   0.6%
5
   0.6%
2
   0.3%
7
   0.9%
19
   0.6%
[1]
Not assessed
[2]
Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 804 participants 799 participants 795 participants 798 participants 3196 participants
804 799 795 798 3196
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 804 participants 799 participants 794 participants 798 participants 3195 participants
78.86  (15.049) 80.22  (15.165) 78.86  (15.302) 79.84  (15.255) 79.44  (15.197)
[1]
Measure Analysis Population Description: N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 804 participants 799 participants 794 participants 798 participants 3195 participants
169.38  (9.596) 169.37  (9.708) 169.37  (10.153) 169.78  (9.424) 169.47  (9.720)
[1]
Measure Analysis Population Description: N=794 for aH5N1C lot#3 and 3195 for total for weight and height.
1.Primary Outcome
Title Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot
Hide Description Hemagglutination Inhibition (HI) GMT was assessed at Day 1 and Day 43 for 3 consecutively produced lots.
Time Frame Day 1, Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set (PPS) - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample (lot-to-lot consistency) at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Arm/Group Title Group A: aH5N1c Lot #1 Group B: aH5N1c Lot #2 Group C: aH5N1c Lot #3
Hide Arm/Group Description:
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
Overall Number of Participants Analyzed 761 747 741
Geometric Mean (95% Confidence Interval)
Unit of Measure: geometric mean titer
Day 1 Number Analyzed 761 participants 747 participants 741 participants
16.1
(15.1 to 17.2)
17.0
(15.9 to 18.2)
17.0
(15.9 to 18.2)
Day 43 Number Analyzed 729 participants 710 participants 717 participants
128.6
(118.9 to 139.1)
127.4
(117.6 to 138.0)
132.2
(122.1 to 143.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A: aH5N1c Lot #1, Group B: aH5N1c Lot #2
Comments aH5N1c Lot #1 vs. aH5N1c Lot #2
Type of Statistical Test Equivalence
Comments Equivalence margin: The 2-sided 95% confidence interval (CI) of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.90 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B: aH5N1c Lot #2, Group C: aH5N1c Lot #3
Comments aH5N1c Lot #2 vs. aH5N1c Lot #3
Type of Statistical Test Equivalence
Comments Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.86 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A: aH5N1c Lot #1, Group C: aH5N1c Lot #3
Comments aH5N1c Lot #1 vs. aH5N1c Lot #3
Type of Statistical Test Equivalence
Comments Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.87 to 1.09
Estimation Comments [Not Specified]
2.Primary Outcome
Title Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort
Hide Description Percentage of subjects with HI titer ≥ 1:40 at Day 43 was assessed by age cohort (18 to <65 years of age and ≥65 years of age) for the pooled lots. Center for Biologics Evaluation and Research (CBER) criterion for subjects aged 18 to <65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%. CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%.
Time Frame Day 1, Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The PPS consisting of all subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons was used for analysis.
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description:
aH5N1c (Active Treatment Groups); receive 2 doses (on Day 1 and Day 22)
Placebo; receive 2 doses (on Day 1 and Day 22)
Overall Number of Participants Analyzed 2249 739
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Day 1, 18 to <65 years Number Analyzed 1116 participants 372 participants
13.0
(10.7 to 15.6)
15.0
(11.5 to 19.4)
Day 1, ≥65 Years Number Analyzed 1133 participants 367 participants
27.8
(24.9 to 30.9)
24.5
(20.1 to 29.6)
Day 43, 18 to <65 years Number Analyzed 1076 participants 349 participants
95.0
(93.4 to 96.2)
8.5
(5.9 to 12.1)
Day 43, ≥65 Years Number Analyzed 1080 participants 351 participants
85.7
(83.3 to 87.9)
20.8
(16.6 to 25.8)
3.Primary Outcome
Title Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Hide Description Percentages of subjects with solicited local, solicited systemic, and other AEs as measured for 7 days (inclusive) following each vaccination (first and second) and any (first or second) vaccination, by treatment group and calculated for several time intervals after vaccination : 30 minutes, 1 to 3 days (without 30 minutes), 4 to 7 days, and 1 to 7 days (without 30 minutes), and 1 to 3 days (including 30 minutes) and 1 to 7 days (including 30 minutes). Analysis for intervals of the first 30 minutes, days 1 to 3, and days 4 to 7 was not performed.
Time Frame Day 1 to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The overall safety set consisting of all subjects who received a study vaccination who underwent any assessment of local and systemic site reaction and/or assessment of any use of analgesics/antipyretics was used for analysis.
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description:
aH5N1c (Active Treatment Groups); receive 2 doses (on Day 1 and Day 22)
Placebo; receive 2 doses (on Day 1 and Day 22)
Overall Number of Participants Analyzed 2395 796
Measure Type: Number
Unit of Measure: percentage of subjects
Any Solicited AE, After Any Vac (D1-D7 excl 30m) Number Analyzed 2352 participants 784 participants
59.7 38.0
Solicited Loc AE, After Any Vac (D1-D7 excl 30m) Number Analyzed 2352 participants 784 participants
50.2 14.7
Solicited Sys AE, After Any Vac (D1-D7 excl 30m) Number Analyzed 2352 participants 784 participants
38.2 32.8
Any Solicited AE, After Vac 1 (D1-D7 excl 30m) Number Analyzed 2346 participants 782 participants
52.4 30.2
Solicited Loc AE, After Vac 1 (D1-D7 excl 30m) Number Analyzed 2346 participants 782 participants
43.2 10.2
Solicited Sys AE, After Vac 1 (D1-D7 excl 30m) Number Analyzed 2346 participants 770 participants
30.7 26.0
Any Solicited AE, After Vac 2 (D1-D7 excl 30m) Number Analyzed 2304 participants 770 participants
41.1 22.3
Solicited Loc AE, After Vac 2 (D1-D7 excl 30m) Number Analyzed 2304 participants 770 participants
33.9 7.4
Solicited Sys AE, After Vac 2 (D1-D7 excl 30m) Number Analyzed 2304 participants 770 participants
21.3 18.6
Any Solicited AE, After Any Vac (D1-D7) Number Analyzed 2395 participants 796 participants
59.3 38.7
Solicited Loc AE, After Any Vac (D1-D7) Number Analyzed 2395 participants 796 participants
50.0 16.3
Solicited Sys AE, After Any Vac (D1-D7) Number Analyzed 2395 participants 796 participants
37.7 32.5
Any Solicited AE, After Vac 1 (D1-D7) Number Analyzed 2395 participants 796 participants
52.0 30.3
Solicited Loc AE, After Vac 1 (D1-D7) Number Analyzed 2395 participants 796 participants
42.8 11.1
Solicited Sys AE, After Vac 1 (D1-D7) Number Analyzed 2395 participants 796 participants
30.3 25.5
Any Solicited AE, After Vac 2 (D1-D7) Number Analyzed 2334 participants 779 participants
41.0 23.1
Solicited Loc AE, After Vac 2 (D1-D7) Number Analyzed 2334 participants 779 participants
34.1 8.3
Solicited Sys AE, After Vac 2 (D1-D7) Number Analyzed 2334 participants 779 participants
21.2 18.9
4.Primary Outcome
Title Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination
Hide Description Percentages of subjects with any unsolicited AEs reported through 21 days after each (first and second) and any (first or second) vaccination by treatment group.
Time Frame Day 1 to Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The unsolicited safety set consisting of all subjects who received a study vaccination and who underwent any AEs assessment (ie, a subject did not have to have any AEs) was used for analysis.
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description:
aH5N1c (Active Treatment Groups); receive 2 doses (on Day 1 and Day 22)
Placebo; receive 2 doses (on Day 1 and Day 22)
Overall Number of Participants Analyzed 2395 796
Measure Type: Number
Unit of Measure: percentage of subjects
Unsolicited AEs, V1 or V2 23.4 22.2
Possibly/probably related unsolicited AE, V1 or V2 7.0 6.2
Unsolicited AE, V1 15.3 13.2
Possibly/probably related unsolicited AE, V1 4.8 3.8
Unsolicited AE, V2 12.2 11.9
Possibly/probably related unsolicited AE, V2 2.8 2.8
5.Primary Outcome
Title Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.
Hide Description Percentages of subjects with any adverse events (AE), adverse events of special interest (AESI), new onset of chronic disease (NOCD), and serious adverse event (SAE) through study termination by treatment group.
Time Frame Day 1 to Day 387
Hide Outcome Measure Data
Hide Analysis Population Description
The unsolicited safety set consisting of all subjects who received a study vaccination and who underwent any AEs assessment (ie, a subject did not have to have any AEs) was used for analysis.
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description:
aH5N1c (Active Treatment Groups); receive 2 doses (on Day 1 and Day 22)
Placebo; receive 2 doses (on Day 1 and Day 22)
Overall Number of Participants Analyzed 2395 796
Measure Type: Number
Unit of Measure: percentage of subjects
SAE 6.7 9.3
Possibly or probably related SAEs 0 0.3
AEs leading to premature withdrawal 0.5 0.4
Medically attended AEs 46.5 46.0
AEs leading to NOCD 9.5 9.2
AESI 0.3 0.9
AE leading to death 0.5 0.1
6.Secondary Outcome
Title Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Hide Description Estimates of hemagglutination inhibition (HI) GMTs, and their associated 95% CIs at Day 1, Day 22, Day 43 and Day 183 were computed using ANCOVA with factors for treatment (active treatment groups or placebo), center and a covariate for the effect defined by the log-transformed prevaccination antibody titer (Day 1).
Time Frame Day 1, Day 22, Day 43, and Day 183
Hide Outcome Measure Data
Hide Analysis Population Description
PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description:
aH5N1c: Active Treatment Groups, received 2 doses on Day 1 and Day 22
Placebo, received 2 doses on Day 1 and Day 22
Overall Number of Participants Analyzed 2249 739
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 1 Number Analyzed 2249 participants 739 participants
16.6
(16.0 to 17.3)
16.7
(15.6 to 17.9)
Day 1, 18 to <65 years Number Analyzed 1116 participants 372 participants
13.5
(12.8 to 14.2)
13.7
(12.5 to 15.0)
Day 1, ≥65 years Number Analyzed 1133 participants 367 participants
20.5
(19.4 to 21.8)
20.6
(18.6 to 22.7)
Day 22 Number Analyzed 2245 participants 736 participants
46.4
(44.5 to 48.4)
13.0
(12.1 to 14.0)
Day 22, 18 to <65 years Number Analyzed 1115 participants 370 participants
50.6
(47.6 to 53.8)
11.6
(10.4 to 12.9)
Day 22, ≥65 years Number Analyzed 1130 participants 366 participants
42.4
(40.0 to 45.0)
14.5
(13.1 to 16.0)
Day 43 Number Analyzed 2156 participants 700 participants
130.6
(124.8 to 136.6)
13.7
(12.6 to 14.8)
Day 43, 18 to <65 years Number Analyzed 1076 participants 349 participants
170.7
(160.5 to 181.6)
11.0
(9.9 to 12.2)
Day 43, ≥65 years Number Analyzed 1080 participants 351 participants
97.9
(92.1 to 104.1)
16.7
(15.0 to 18.5)
Day 183 Number Analyzed 2079 participants 687 participants
20.0
(19.2 to 20.8)
7.7
(7.2 to 8.2)
Day 183, 18 to <65 years Number Analyzed 1025 participants 341 participants
20.4
(19.3 to 21.6)
6.8
(6.1 to 7.4)
Day 183, ≥65 years Number Analyzed 1054 participants 346 participants
19.3
(18.2 to 20.4)
8.6
(7.8 to 9.5)
7.Secondary Outcome
Title Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Hide Description

The percentage of subjects with HI titer ≥1:40 data over time by vaccine group and age cohort are presented. CBER criterion for subjects aged 18 to <65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.

CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%.

Time Frame Day 1, Day 22, Day 43 and Day 183
Hide Outcome Measure Data
Hide Analysis Population Description
PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description:
aH5N1c: Active Treatment Groups, received 2 doses on Day 1 and Day 22
Placebo, received 2 doses on Day 1 and Day 22
Overall Number of Participants Analyzed 2249 739
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Day 1 Number Analyzed 2249 participants 739 participants
22.9
(21.1 to 24.6)
22.6
(19.6 to 25.8)
Day 1, 18 to <65 years Number Analyzed 1116 participants 372 participants
17.4
(15.2 to 19.7)
19.6
(15.7 to 24.0)
Day 1, ≥65 years Number Analyzed 1133 participants 367 participants
28.2
(25.6 to 31.0)
25.6
(21.2 to 30.4)
Day 22 Number Analyzed 2245 participants 736 participants
59.3
(57.2 to 61.3)
14.9
(12.4 to 17.7)
Day 22, 18 to <65 years Number Analyzed 1115 participants 370 participants
63.0
(60.1 to 65.9)
13.5
(10.2 to 17.4)
Day 22, ≥65 years Number Analyzed 1130 participants 366 participants
55.6
(52.6 to 58.5)
16.4
(12.7 to 20.6)
Day 43 Number Analyzed 2156 participants 700 participants
88.3
(86.9 to 89.6)
16.9
(14.2 to 19.8)
Day 43, 18 to <65 years Number Analyzed 1076 participants 349 participants
93.1
(91.4 to 94.6)
10.9
(7.8 to 14.6)
Day 43, ≥65 years Number Analyzed 1080 participants 351 participants
83.5
(81.2 to 85.7)
22.8
(18.5 to 27.5)
Day 183 Number Analyzed 2079 participants 687 participants
32.6
(30.6 to 34.6)
5.2
(3.7 to 7.2)
Day 183, 18 to <65 years Number Analyzed 1025 participants 341 participants
34.2
(31.3 to 37.2)
2.1
(0.8 to 4.2)
Day 183, ≥65 years Number Analyzed 1054 participants 346 participants
30.9
(28.1 to 33.8)
8.4
(5.7 to 11.8)
8.Secondary Outcome
Title Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).
Hide Description Percentage of subjects achieving seroconversion (defined as: HI titer ≥1:40 for subjects negative at baseline [HI titer <1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI titer ≥1:10]) on Day 22, and Day 43 by vaccine group (aH5N1c or placebo) and by age cohort (18 to <65 years of age and ≥65 years of age).
Time Frame Day 22, and Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description:
aH5N1c: Active Treatment Groups, received 2 doses on Day 1 and Day 22
Placebo, received 2 doses on Day 1 and Day 22
Overall Number of Participants Analyzed 2249 739
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Day 22 Number Analyzed 2245 participants 736 participants
32.2
(30.3 to 34.2)
1.1
(0.5 to 2.1)
Day 22, 18 to <65 years Number Analyzed 1115 participants 370 participants
40.4
(37.6 to 43.4)
1.9
(0.8 to 3.9)
Day 22, ≥65 years Number Analyzed 1130 participants 366 participants
24.2
(21.7 to 26.8)
0.3
(0.0 to 1.5)
Day 43 Number Analyzed 2156 participants 700 participants
66.9
(64.9 to 68.9)
1.0
(0.4 to 2.0)
Day 43, 18 to <65 years Number Analyzed 1076 participants 349 participants
79.9
(77.4 to 82.3)
0.3
(0.0 to 1.6)
Day 43, ≥65 Years Number Analyzed 1080 participants 351 participants
54.0
(51.0 to 57.0)
1.7
(0.6 to 3.7)
9.Secondary Outcome
Title Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Hide Description Hemagglutination inhibition (HI) GMTs were assessed over time for the vaccine group and age cohort. Adjusted estimates of GMTs, and their associated 95% CIs at Day 1, Day 22, Day 43 and Day 183 were computed using ANCOVA with factors for treatment (active treatment groups or placebo), center and a covariate for the effect defined by the log-transformed prevaccination antibody titer (Day 1).
Time Frame Day 1, Day 22, Day 43 and Day 183
Hide Outcome Measure Data
Hide Analysis Population Description
PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description:
aH5N1c: Active Treatment Groups, received 2 doses on Day 1 and Day 22
Placebo, received 2 doses on Day 1 and Day 22
Overall Number of Participants Analyzed 2249 739
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: titer
Day 1, 18 to <60 years Number Analyzed 980 participants 331 participants
13.0
(12.3 to 13.8)
13.4
(12.2 to 14.7)
Day 1, ≥60 years Number Analyzed 1269 participants 408 participants
20.1
(19.1 to 21.3)
20.1
(18.3 to 22.0)
Day 22, 18 to <60 years Number Analyzed 979 participants 329 participants
51.1
(47.9 to 54.6)
11.2
(10.0 to 12.5)
Day 22, ≥60 years Number Analyzed 1266 participants 407 participants
42.9
(40.5 to 45.3)
14.4
(13.1 to 15.9)
Day 43, 18 to <60 years Number Analyzed 947 participants 309 participants
177.4
(166.2 to 189.4)
10.7
(9.5 to 11.9)
Day 43, ≥60 years Number Analyzed 1209 participants 391 participants
100.7
(95.0 to 106.7)
16.2
(14.7 to 17.9)
Day 183, 18 to <60 years Number Analyzed 899 participants 302 participants
20.4
(19.3 to 21.7)
6.7
(6.0 to 7.4)
Day 183, ≥60 years Number Analyzed 1180 participants 385 participants
19.3
(18.3 to 20.4)
8.5
(7.7 to 9.3)
10.Secondary Outcome
Title Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Hide Description The percentage of subjects with HI titer ≥1:40 data over time by vaccine group and age cohort. Committee for Medicinal Products for Human Use (CHMP) criterion for subjects aged 18 to <60 years: The percentage of subjects achieving an HI titer ≥1:40 is >70%. CHMP criterion for subjects aged ≥60 years: The percentage of subjects achieving an HI titer ≥1:40 is >60%.
Time Frame Day 1, Day 22, Day 43, and Day 183
Hide Outcome Measure Data
Hide Analysis Population Description
PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description:
aH5N1c: Active Treatment Groups, received 2 doses on Day 1 and Day 22
Placebo, received 2 doses on Day 1 and Day 22
Overall Number of Participants Analyzed 2249 739
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Day 1, 18 to <60 years Number Analyzed 980 participants 331 participants
17.1
(14.8 to 19.7)
19.6
(15.5 to 24.3)
Day 1, ≥60 years Number Analyzed 1269 participants 408 participants
27.3
(24.8 to 29.8)
25.0
(20.9 to 29.5)
Day 22, 18 to <60 years Number Analyzed 979 participants 329 participants
63.2
(60.1 to 66.3)
12.2
(8.8 to 16.2)
Day 22, ≥60 years Number Analyzed 1266 participants 407 participants
56.2
(53.5 to 59.0)
17.2
(13.7 to 21.2)
Day 43, 18 to <60 years Number Analyzed 947 participants 309 participants
93.6
(91.8 to 95.0)
10.0
(6.9 to 13.9)
Day 43, ≥60 years Number Analyzed 1209 participants 391 participants
84.2
(82.0 to 86.2)
22.3
(18.2 to 26.7)
Day 183, 18 to <60 years Number Analyzed 899 participants 302 participants
34.3
(31.2 to 37.5)
2.3
(0.9 to 4.7)
Day 183, ≥60 years Number Analyzed 1180 participants 385 participants
31.3
(28.6 to 34.0)
7.5
(5.1 to 10.6)
11.Secondary Outcome
Title Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Hide Description Percentage of subjects achieving seroconversion (defined as: HI titer ≥1:40 for subjects negative at baseline [HI titer <1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI titer ≥1:10]) on Day 22, and Day 43 by vaccine group (aH5N1c or placebo) and by age cohort (18 to <60 years of age and ≥60 years of age)
Time Frame Day 22, and Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description:
aH5N1c: Active Treatment Groups, received 2 doses on Day 1 and Day 22
Placebo, received 2 doses on Day 1 and Day 22
Overall Number of Participants Analyzed 2249 739
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Day 22, 18 to <60 years Number Analyzed 979 participants 329 participants
42.2
(39.1 to 45.4)
1.5
(0.5 to 3.5)
Day 22, ≥60 years Number Analyzed 1266 participants 407 participants
24.6
(22.2 to 27.0)
0.7
(0.2 to 2.1)
Day 43, 18 to <60 years Number Analyzed 947 participants 309 participants
81.6
(79.0 to 84.0)
0.3
(0.0 to 1.8)
Day 43, ≥60 years Number Analyzed 1209 participants 391 participants
55.4
(52.6 to 58.2)
1.5
(0.6 to 3.3)
12.Secondary Outcome
Title Secondary Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Haemagglutination Inhibition (HI) Titer: Day 22/Day 1, Day 43/Day 1 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)
Hide Description The GMR of HI titers (Day 22/Day 1, Day 43/Day 1) is presented for the vaccine groups and age cohort. CHMP criterion for subjects aged 18 to <60 years: GMR is >2.5. CHMP criterion for subjects aged ≥60 years: GMR is >2.0.
Time Frame Day 1, Day 22, Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description:
aH5N1c: Active Treatment Groups, received 2 doses on Day 1 and Day 22
Placebo, received 2 doses on Day 1 and Day 22
Overall Number of Participants Analyzed 2249 739
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: ratio
Day 22/Day 1, Overall Number Analyzed 2245 participants 736 participants
2.86
(2.74 to 2.98)
0.80
(0.77 to 0.90)
Day 43/Day 1, Overall Number Analyzed 2156 participants 700 participants
7.96
(7.61 to 8.33)
0.83
(0.74 to 0.86)
Day 22/Day 1, 18 to <60 years Number Analyzed 979 participants 329 participants
3.92
(3.67 to 4.18)
0.85
(0.76 to 0.96)
Day 22/Day 1, ≥60 years Number Analyzed 1266 participants 407 participants
2.22
(2.10 to 2.35)
0.75
(0.68 to 0.82)
Day 43/Day 1, 18 to <60 years Number Analyzed 947 participants 309 participants
13.44
(12.59 to 14.35)
0.81
(0.72 to 0.90)
Day 43/Day 1, ≥60 years Number Analyzed 1209 participants 391 participants
5.18
(4.88 to 5.49)
0.83
(0.76 to 0.92)
Time Frame Day 1 to Day 387
Adverse Event Reporting Description

The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).

After lot-to-lot consistency was demonstrated, the populations of all aH5N1c vaccine recipients were pooled in order to evaluate immunogenicity and safety. Therefore, the H5N1c arms are pooled for the safety assessments.

 
Arm/Group Title aH5N1c Placebo
Hide Arm/Group Description aH5N1c (Active Treatment Groups); receive 2 doses (on Day 1 and Day 22) Placebo; receive 2 doses (on Day 1 and Day 22)
All-Cause Mortality
aH5N1c Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   11/2395 (0.46%)   1/796 (0.13%) 
Show Serious Adverse Events Hide Serious Adverse Events
aH5N1c Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   161/2395 (6.72%)   74/796 (9.30%) 
Blood and lymphatic system disorders     
Anaemia  1  2/2395 (0.08%)  0/796 (0.00%) 
Febrile neutropenia  1  1/2395 (0.04%)  0/796 (0.00%) 
Immune thrombocytopenic purpura  1  0/2395 (0.00%)  1/796 (0.13%) 
Cardiac disorders     
Atrial fibrillation  1  8/2395 (0.33%)  8/796 (1.01%) 
Coronary artery disease  1  3/2395 (0.13%)  3/796 (0.38%) 
Myocardial infarction  1  2/2395 (0.08%)  4/796 (0.50%) 
Acute myocardial infarction  1  4/2395 (0.17%)  1/796 (0.13%) 
Cardiac failure congestive  1  1/2395 (0.04%)  3/796 (0.38%) 
Angina pectoris  1  3/2395 (0.13%)  0/796 (0.00%) 
Atrial flutter  1  2/2395 (0.08%)  0/796 (0.00%) 
Atrioventricular block  1  1/2395 (0.04%)  1/796 (0.13%) 
Cardio-respiratory arrest  1  2/2395 (0.08%)  0/796 (0.00%) 
Hypertensive heart disease  1  2/2395 (0.08%)  0/796 (0.00%) 
Acute coronary syndrome  1  0/2395 (0.00%)  1/796 (0.13%) 
Angina unstable  1  1/2395 (0.04%)  0/796 (0.00%) 
Aortic valve incompetence  1  1/2395 (0.04%)  0/796 (0.00%) 
Arrhythmia  1  1/2395 (0.04%)  0/796 (0.00%) 
Bradycardia  1  1/2395 (0.04%)  0/796 (0.00%) 
Cardiac failure  1  0/2395 (0.00%)  1/796 (0.13%) 
Cardiac failure acute  1  0/2395 (0.00%)  1/796 (0.13%) 
Cardiac perforation  1  0/2395 (0.00%)  1/796 (0.13%) 
Cardiac tamponade  1  0/2395 (0.00%)  1/796 (0.13%) 
Cardiogenic shock  1  0/2395 (0.00%)  1/796 (0.13%) 
Pericarditis  1  0/2395 (0.00%)  1/796 (0.13%) 
Sinus tachycardia  1  1/2395 (0.04%)  0/796 (0.00%) 
Stress cardiomyopathy  1  1/2395 (0.04%)  0/796 (0.00%) 
Supraventricular tachycardia  1  1/2395 (0.04%)  0/796 (0.00%) 
Ear and labyrinth disorders     
Vertigo positional  1  1/2395 (0.04%)  1/796 (0.13%) 
Gastrointestinal disorders     
Gastritis alcoholic  1  2/2395 (0.08%)  0/796 (0.00%) 
Nausea  1  2/2395 (0.08%)  0/796 (0.00%) 
Pancreatitis  1  0/2395 (0.00%)  2/796 (0.25%) 
Small intestinal obstruction  1  1/2395 (0.04%)  1/796 (0.13%) 
Vomiting  1  2/2395 (0.08%)  0/796 (0.00%) 
Abdominal pain upper  1  1/2395 (0.04%)  0/796 (0.00%) 
Abdominal strangulated hernia  1  1/2395 (0.04%)  0/796 (0.00%) 
Coeliac disease  1  0/2395 (0.00%)  1/796 (0.13%) 
Colitis  1  1/2395 (0.04%)  0/796 (0.00%) 
Colitis ulcerative  1  0/2395 (0.00%)  1/796 (0.13%) 
Constipation  1  1/2395 (0.04%)  0/796 (0.00%) 
Diverticulum intestinal haemorrhagic  1  1/2395 (0.04%)  0/796 (0.00%) 
Gastric ulcer haemorrhage  1  1/2395 (0.04%)  0/796 (0.00%) 
Gastritis  1  1/2395 (0.04%)  0/796 (0.00%) 
Gastrointestinal haemorrhage  1  0/2395 (0.00%)  1/796 (0.13%) 
Gastrooesophageal reflux disease  1  1/2395 (0.04%)  0/796 (0.00%) 
Intestinal obstruction  1  1/2395 (0.04%)  0/796 (0.00%) 
Intestinal perforation  1  1/2395 (0.04%)  0/796 (0.00%) 
Large intestine perforation  1  0/2395 (0.00%)  1/796 (0.13%) 
Lower gastrointestinal haemorrhage  1  1/2395 (0.04%)  0/796 (0.00%) 
Oesophageal ulcer  1  1/2395 (0.04%)  0/796 (0.00%) 
Oesophageal varices haemorrhage  1  1/2395 (0.04%)  0/796 (0.00%) 
Pancreatic pseudocyst  1  1/2395 (0.04%)  0/796 (0.00%) 
Rectal haemorrhage  1  0/2395 (0.00%)  1/796 (0.13%) 
Small intestinal perforation  1  0/2395 (0.00%)  1/796 (0.13%) 
Upper gastrointestinal haemorrhage  1  1/2395 (0.04%)  0/796 (0.00%) 
General disorders     
Non-cardiac chest pain  1  2/2395 (0.08%)  0/796 (0.00%) 
Chest pain  1  1/2395 (0.04%)  0/796 (0.00%) 
Death  1  1/2395 (0.04%)  0/796 (0.00%) 
Perforated ulcer  1  1/2395 (0.04%)  0/796 (0.00%) 
Systemic inflammatory response syndrome  1  0/2395 (0.00%)  1/796 (0.13%) 
Hepatobiliary disorders     
Cholecystitis  1  2/2395 (0.08%)  1/796 (0.13%) 
Cholecystitis acute  1  1/2395 (0.04%)  1/796 (0.13%) 
Biliary cirrhosis primary  1  0/2395 (0.00%)  1/796 (0.13%) 
Cholelithiasis  1  1/2395 (0.04%)  0/796 (0.00%) 
Gallbladder obstruction  1  1/2395 (0.04%)  0/796 (0.00%) 
Appendicitis  1  1/2395 (0.04%)  1/796 (0.13%) 
Immune system disorders     
Food allergy  1  1/2395 (0.04%)  0/796 (0.00%) 
Sarcoidosis  1  1/2395 (0.04%)  0/796 (0.00%) 
Infections and infestations     
Pneumonia  1  4/2395 (0.17%)  2/796 (0.25%) 
Diverticulitis  1  2/2395 (0.08%)  1/796 (0.13%) 
Bronchitis  1  1/2395 (0.04%)  1/796 (0.13%) 
Gastroenteritis  1  1/2395 (0.04%)  1/796 (0.13%) 
Sepsis  1  1/2395 (0.04%)  1/796 (0.13%) 
Septic shock  1  1/2395 (0.04%)  1/796 (0.13%) 
Urinary tract infection  1  2/2395 (0.08%)  0/796 (0.00%) 
Device related infection  1  1/2395 (0.04%)  0/796 (0.00%) 
Endocarditis  1  1/2395 (0.04%)  0/796 (0.00%) 
Enterococcal infection  1  1/2395 (0.04%)  0/796 (0.00%) 
Escherichia urinary tract infection  1  1/2395 (0.04%)  0/796 (0.00%) 
External ear cellulitis  1  1/2395 (0.04%)  0/796 (0.00%) 
Gallbladder abscess  1  1/2395 (0.04%)  0/796 (0.00%) 
Incision site cellulitis  1  1/2395 (0.04%)  0/796 (0.00%) 
Influenza  1  1/2395 (0.04%)  0/796 (0.00%) 
Labyrinthitis  1  1/2395 (0.04%)  0/796 (0.00%) 
Lower respiratory tract infection  1  0/2395 (0.00%)  1/796 (0.13%) 
Metapneumovirus infection  1  1/2395 (0.04%)  0/796 (0.00%) 
Pneumonia mycoplasmal  1  1/2395 (0.04%)  0/796 (0.00%) 
Pseudomonal bacteraemia  1  1/2395 (0.04%)  0/796 (0.00%) 
Pyelonephritis  1  0/2395 (0.00%)  1/796 (0.13%) 
Shigella infection  1  1/2395 (0.04%)  0/796 (0.00%) 
Soft tissue infection  1  1/2395 (0.04%)  0/796 (0.00%) 
Tonsillitis  1  0/2395 (0.00%)  1/796 (0.13%) 
Urosepsis  1  1/2395 (0.04%)  0/796 (0.00%) 
Injury, poisoning and procedural complications     
Spinal compression fracture  1  4/2395 (0.17%)  0/796 (0.00%) 
Ankle fracture  1  1/2395 (0.04%)  1/796 (0.13%) 
Tibia fracture  1  2/2395 (0.08%)  0/796 (0.00%) 
Bone contusion  1  1/2395 (0.04%)  0/796 (0.00%) 
Cervical vertebral fracture  1  1/2395 (0.04%)  0/796 (0.00%) 
Femur fracture  1  1/2395 (0.04%)  0/796 (0.00%) 
Gun shot wound  1  1/2395 (0.04%)  0/796 (0.00%) 
Lower limb fracture  1  1/2395 (0.04%)  0/796 (0.00%) 
Overdose  1  1/2395 (0.04%)  0/796 (0.00%) 
Rib fracture  1  1/2395 (0.04%)  0/796 (0.00%) 
Subdural haematoma  1  1/2395 (0.04%)  0/796 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  2/2395 (0.08%)  2/796 (0.25%) 
Diabetic ketoacidosis  1  1/2395 (0.04%)  0/796 (0.00%) 
Hyponatraemia  1  1/2395 (0.04%)  0/796 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  15/2395 (0.63%)  4/796 (0.50%) 
Back pain  1  2/2395 (0.08%)  1/796 (0.13%) 
Spondylolisthesis  1  3/2395 (0.13%)  0/796 (0.00%) 
Intervertebral disc protrusion  1  2/2395 (0.08%)  0/796 (0.00%) 
Lumbar spinal stenosis  1  2/2395 (0.08%)  0/796 (0.00%) 
Polymyalgia rheumatica  1  1/2395 (0.04%)  1/796 (0.13%) 
Arthritis  1  0/2395 (0.00%)  1/796 (0.13%) 
Coccydynia  1  1/2395 (0.04%)  0/796 (0.00%) 
Intervertebral disc degeneration  1  1/2395 (0.04%)  0/796 (0.00%) 
Muscular weakness  1  1/2395 (0.04%)  0/796 (0.00%) 
Periarthritis  1  1/2395 (0.04%)  0/796 (0.00%) 
Rheumatoid arthritis  1  0/2395 (0.00%)  1/796 (0.13%) 
Spinal column stenosis  1  1/2395 (0.04%)  0/796 (0.00%) 
Spinal osteoarthritis  1  1/2395 (0.04%)  0/796 (0.00%) 
Synovitis  1  1/2395 (0.04%)  0/796 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma  1  5/2395 (0.21%)  1/796 (0.13%) 
B-cell lymphoma  1  2/2395 (0.08%)  0/796 (0.00%) 
Breast cancer  1  2/2395 (0.08%)  0/796 (0.00%) 
Invasive ductal breast carcinoma  1  1/2395 (0.04%)  1/796 (0.13%) 
Lung neoplasm malignant  1  1/2395 (0.04%)  1/796 (0.13%) 
Prostate cancer  1  0/2395 (0.00%)  2/796 (0.25%) 
Acute myeloid leukaemia  1  1/2395 (0.04%)  0/796 (0.00%) 
Clear cell renal cell carcinoma  1  1/2395 (0.04%)  0/796 (0.00%) 
Ductal adenocarcinoma of pancreas  1  1/2395 (0.04%)  0/796 (0.00%) 
Lung adenocarcinoma  1  1/2395 (0.04%)  0/796 (0.00%) 
Lung adenocarcinoma stage IV  1  1/2395 (0.04%)  0/796 (0.00%) 
Lymphoma  1  1/2395 (0.04%)  0/796 (0.00%) 
Oesophageal carcinoma  1  0/2395 (0.00%)  1/796 (0.13%) 
Pancreatic carcinoma  1  1/2395 (0.04%)  0/796 (0.00%) 
Papillary thyroid cancer  1  1/2395 (0.04%)  0/796 (0.00%) 
Pituitary tumour benign  1  0/2395 (0.00%)  1/796 (0.13%) 
Plasma cell myeloma  1  1/2395 (0.04%)  0/796 (0.00%) 
Prostate cancer stage II  1  1/2395 (0.04%)  0/796 (0.00%) 
Rectal adenocarcinoma  1  0/2395 (0.00%)  1/796 (0.13%) 
Transitional cell carcinoma  1  0/2395 (0.00%)  1/796 (0.13%) 
Uterine cancer  1  1/2395 (0.04%)  0/796 (0.00%) 
Uterine leiomyoma  1  0/2395 (0.00%)  1/796 (0.13%) 
Nervous system disorders     
Syncope  1  2/2395 (0.08%)  3/796 (0.38%) 
Transient ischaemic attack  1  3/2395 (0.13%)  1/796 (0.13%) 
Carotid artery stenosis  1  2/2395 (0.08%)  1/796 (0.13%) 
Basal ganglia infarction  1  1/2395 (0.04%)  0/796 (0.00%) 
Brain stem infarction  1  0/2395 (0.00%)  1/796 (0.13%) 
Carpal tunnel syndrome  1  1/2395 (0.04%)  0/796 (0.00%) 
Cerebellar haemorrhage  1  1/2395 (0.04%)  0/796 (0.00%) 
Cerebellar stroke  1  1/2395 (0.04%)  0/796 (0.00%) 
Cerebral haematoma  1  1/2395 (0.04%)  0/796 (0.00%) 
Cerebral infarction  1  1/2395 (0.04%)  0/796 (0.00%) 
Cerebrovascular accident  1  1/2395 (0.04%)  0/796 (0.00%) 
Chronic inflammatory demyelinating polyradiculoneuropathy  1  1/2395 (0.04%)  0/796 (0.00%) 
Encephalopathy  1  1/2395 (0.04%)  0/796 (0.00%) 
Haemorrhagic stroke  1  1/2395 (0.04%)  0/796 (0.00%) 
Hypoaesthesia  1  1/2395 (0.04%)  0/796 (0.00%) 
Intracranial aneurysm  1  0/2395 (0.00%)  1/796 (0.13%) 
Neuropathy peripheral  1  1/2395 (0.04%)  0/796 (0.00%) 
Presyncope  1  1/2395 (0.04%)  0/796 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/2395 (0.04%)  1/796 (0.13%) 
Abortion spontaneous incomplete  1  0/2395 (0.00%)  1/796 (0.13%) 
Psychiatric disorders     
Acute psychosis  1  0/2395 (0.00%)  1/796 (0.13%) 
Bipolar disorder  1  0/2395 (0.00%)  1/796 (0.13%) 
Borderline personality disorder  1  0/2395 (0.00%)  1/796 (0.13%) 
Psychotic disorder  1  0/2395 (0.00%)  1/796 (0.13%) 
Suicide attempt  1  1/2395 (0.04%)  0/796 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  3/2395 (0.13%)  0/796 (0.00%) 
Nephrolithiasis  1  1/2395 (0.04%)  1/796 (0.13%) 
Hydronephrosis  1  1/2395 (0.04%)  0/796 (0.00%) 
Renal failure  1  1/2395 (0.04%)  0/796 (0.00%) 
Ureterolithiasis  1  1/2395 (0.04%)  0/796 (0.00%) 
Urinary retention  1  1/2395 (0.04%)  0/796 (0.00%) 
Adenomyosis  1  0/2395 (0.00%)  1/796 (0.13%) 
Benign prostatic hyperplasia  1  1/2395 (0.04%)  0/796 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  5/2395 (0.21%)  2/796 (0.25%) 
Respiratory failure  1  3/2395 (0.13%)  4/796 (0.50%) 
Pulmonary embolism  1  2/2395 (0.08%)  2/796 (0.25%) 
Acute respiratory failure  1  1/2395 (0.04%)  0/796 (0.00%) 
Asthma  1  1/2395 (0.04%)  0/796 (0.00%) 
Dyspnoea  1  0/2395 (0.00%)  1/796 (0.13%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/2395 (0.04%)  0/796 (0.00%) 
Surgical and medical procedures     
Hospitalisation  1  1/2395 (0.04%)  0/796 (0.00%) 
Vascular disorders     
Aortic stenosis  1  1/2395 (0.04%)  1/796 (0.13%) 
Peripheral arterial occlusive disease  1  0/2395 (0.00%)  2/796 (0.25%) 
Aortic aneurysm  1  1/2395 (0.04%)  0/796 (0.00%) 
Deep vein thrombosis  1  0/2395 (0.00%)  1/796 (0.13%) 
Haematoma  1  1/2395 (0.04%)  0/796 (0.00%) 
Hypertension  1  1/2395 (0.04%)  0/796 (0.00%) 
Orthostatic hypotension  1  1/2395 (0.04%)  0/796 (0.00%) 
Thrombosis  1  1/2395 (0.04%)  0/796 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
aH5N1c Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   91/2395 (3.80%)   44/796 (5.53%) 
Infections and infestations     
Upper respiratory tract infection  1  91/2395 (3.80%)  44/796 (5.53%) 
1
Term from vocabulary, MedDRA 20.0
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
Name/Title: Seqirus Clinical Trial Disclosure Manager
Organization: Seqirus
Phone: 1-855-358-8966
Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT02839330     History of Changes
Other Study ID Numbers: V89_18
First Submitted: July 18, 2016
First Posted: July 20, 2016
Results First Submitted: February 26, 2019
Results First Posted: April 4, 2019
Last Update Posted: April 4, 2019