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Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children

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ClinicalTrials.gov Identifier: NCT02539108
Recruitment Status : Completed
First Posted : September 2, 2015
Results First Posted : October 20, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Fluzone® Quadrivalent Influenza Vaccine, No Preservative
Enrollment 60
Recruitment Details Study participants were enrolled from 31 August 2015 to 30 November 2015 at 2 clinic centers in the United States.
Pre-assignment Details A total of 60 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.
Arm/Group Title 6 to <36 Months of Age 3 to <9 Years of Age
Hide Arm/Group Description Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines. Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title 6 to <36 Months of Age 3 to <9 Years of Age Total
Hide Arm/Group Description Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines. Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
30
 100.0%
30
 100.0%
60
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 30 participants 30 participants 60 participants
21.9  (8.59) 72.0  (22.9) 46.9  (30.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
20
  66.7%
14
  46.7%
34
  56.7%
Male
10
  33.3%
16
  53.3%
26
  43.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine.
Hide Description

Solicited injection-site reactions for 6 to < 36 months: Tenderness, Erythema, and Swelling. For 3 to < 9 years: Pain, Erythema, and Swelling. Solicited systemic reactions for 6 to < 36 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. For 3 to < 9 years: Fever (Temperature), Headache, Malaise, and Myalgia.

Grade 3 for 6 to < 36 months: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Vomiting, 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.

Grade 3 for 3 to < 9 years: Pain, Incapacitating; Erythema and Swelling, ≥ 50 mm; Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, prevents daily activity.

Time Frame Day 0 up to Day 7 post any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title 6 to <36 Months of Age 3 to <9 Years of Age
Hide Arm/Group Description:
Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Participants
Injection-Site Tenderness (N=30, 0) 21 NA [1] 
Grade 3 Injection-Site Tenderness 0 NA [1] 
Injection-Site Pain (N=0, 30) NA [1]  16
Grade 3 Injection-site Pain NA [1]  0
Injection-Site Erythema 11 11
Grade 3 Injection-Site Erythema 0 0
Injection-Site Swelling 3 8
Grade 3 Injection-Site Swelling 0 0
Fever 4 2
Grade 3 Fever 0 2
Vomiting (N=30, 0) 1 NA [1] 
Grade 3 Vomiting 0 NA [1] 
Crying abnormal (N=30, 0) 9 NA [1] 
Grade 3 Crying abnormal 0 NA [1] 
Drowsiness (N=30, 0) 8 NA [1] 
Grade 3 Drowsiness 0 NA [1] 
Appetite lost (N=30, 0) 9 NA [1] 
Grade 3 Appetite lost 0 NA [1] 
Irritability (N=30, 0) 15 NA [1] 
Grade 3 Irritability 0 NA [1] 
Headache (N=0, 30) NA [1]  2
Grade 3 Headache NA [1]  0
Malaise(N=0, 30) NA [1]  6
Grade 3 Malaise NA [1]  0
Myalgia (N=0, 30) NA [1]  10
Grade 3 Myalgia NA [1]  0
[1]
Event was not assessed in this group
2.Secondary Outcome
Title Geometric Mean Titers of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Hide Description Anti-influenza antibodies were measured using an hemagglutination inhibition assay.
Time Frame Day 0 (pre-vaccination) and 28 days post-last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-influenza antibody titers were assessed in the Per-protocol Analysis Set.
Arm/Group Title 6 to <36 Months of Age 3 to <9 Years of Age
Hide Arm/Group Description:
Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
Overall Number of Participants Analyzed 30 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
A/H1N1; Pre-vaccination
14.8
(8.60 to 25.5)
184
(85.3 to 396)
A/H1N1; Post-vaccination
288
(167 to 498)
937
(625 to 1406)
A/H3N2; Pre-vaccination
28.9
(13.5 to 62.0)
139
(79.8 to 243)
A/H3N2; Post-vaccination
1140
(576 to 2259)
3263
(2255 to 4721)
B Yamagata; Pre-vaccination
16.2
(10.7 to 24.7)
113
(64.3 to 199)
B Yamagata; Post-vaccination
408
(257 to 646)
1028
(659 to 1604)
B Victoria; Pre-vaccination
14.0
(8.35 to 23.4)
108
(54.1 to 216)
B Victoria; Post-vaccination
339
(207 to 555)
718
(462 to 1118)
3.Secondary Outcome
Title Number of Participants Who Achieved Seroprotection to Influenza Virus Antigens Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Hide Description Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as a pre-vaccination or post-vaccination influenza antibody titer of ≥ 1:40 (1/dilutions).
Time Frame Day 0 (pre-vaccination) and 28 days post-last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-influenza antibody titers were assessed in the Per-Protocol Analysis Set.
Arm/Group Title 6 to <36 Months of Age 3 to <9 Years of Age
Hide Arm/Group Description:
Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Participants
A/H1N1; Pre-vaccination 10 22
A/H1N1; Post-vaccination 28 30
A/H3N2; Pre-vaccination 14 26
A/H3N2; Post-vaccination 29 30
B Yamagata; Pre-vaccination 8 23
B Yamagata; Post-vaccination 29 30
B Victoria; Pre-vaccination 7 20
B Victoria; Post-vaccination 28 30
4.Secondary Outcome
Title Number of Participants Who Achieved Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Hide Description Anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-final vaccination titer.
Time Frame 28 days post-last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-influenza antibody titers were assessed in the Per-Protocol Analysis Set.
Arm/Group Title 6 to <36 Months of Age 3 to <9 Years of Age
Hide Arm/Group Description:
Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Participants
A/H1N1 24 15
A/H3N2 28 28
B Yamagata 28 24
B Victoria 27 21
5.Secondary Outcome
Title Geometric Mean Titer Ratios of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Hide Description Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios
Time Frame Day 0 (pre-vaccination) and 28 days post-last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-influenza antibody titers were assessed in the Per-protocol Analysis Set.
Arm/Group Title 6 to <36 Months of Age 3 to <9 Years of Age
Hide Arm/Group Description:
Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
Overall Number of Participants Analyzed 30 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratio
A/H1N1
13.0
(7.63 to 22.1)
4.59
(2.93 to 7.21)
A/H3N2
28.2
(17.0 to 46.8)
22.9
(15.0 to 34.9)
B Yamagata
21.1
(13.5 to 32.9)
8.67
(5.76 to 13.1)
B Victoria
17.3
(10.8 to 28.0)
6.35
(4.17 to 9.66)
Time Frame Adverse event data were collected from Day 0 up to 28 days following the last vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 6 to <36 Months of Age 3 to <9 Years of Age
Hide Arm/Group Description Children 6 to < 36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines. Children 3 to < 9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
All-Cause Mortality
6 to <36 Months of Age 3 to <9 Years of Age
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
6 to <36 Months of Age 3 to <9 Years of Age
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      0/30 (0.00%)    
Skin and subcutaneous tissue disorders     
Linear IgA disease * 1  1/30 (3.33%)  1 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
6 to <36 Months of Age 3 to <9 Years of Age
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/30 (70.00%)      16/30 (53.33%)    
Gastrointestinal disorders     
Diarrhoea * 1  2/30 (6.67%)  2 1/30 (3.33%)  1
Teething * 1  2/30 (6.67%)  2 0/30 (0.00%)  0
General disorders     
Injection site Tenderness / Pain  1  21/30 (70.00%)  21 16/30 (53.33%)  16
Injection site Erythema  1  11/30 (36.67%)  11 11/30 (36.67%)  11
Injection site Swelling  1  3/30 (10.00%)  3 8/30 (26.67%)  8
Fever  1  4/30 (13.33%)  4 2/30 (6.67%)  2
Malaise  1  0/30 (0.00%)  0 6/30 (20.00%)  6
Infections and infestations     
Otitis media acute * 1  3/30 (10.00%)  3 0/30 (0.00%)  0
Upper respiratory tract infection * 1  5/30 (16.67%)  7 2/30 (6.67%)  2
Metabolism and nutrition disorders     
Appetite lost  1  9/30 (30.00%)  9 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Myalgia  1  0/30 (0.00%)  0 10/30 (33.33%)  10
Nervous system disorders     
Drowsiness  1  8/30 (26.67%)  8 0/30 (0.00%)  0
Headache  1  0/30 (0.00%)  0 2/30 (6.67%)  2
Psychiatric disorders     
Crying abnormal  1  9/30 (30.00%)  9 0/30 (0.00%)  0
Irritability  1  15/30 (50.00%)  15 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  3/30 (10.00%)  3 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis diaper * 1  2/30 (6.67%)  2 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v18.0
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02539108     History of Changes
Other Study ID Numbers: GRC58
U1111-1161-2526 ( Other Identifier: WHO )
First Submitted: August 31, 2015
First Posted: September 2, 2015
Results First Submitted: August 26, 2016
Results First Posted: October 20, 2016
Last Update Posted: November 29, 2016