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Trial record 1 of 1 for:    GRC56
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Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine

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ClinicalTrials.gov Identifier: NCT02222870
Recruitment Status : Completed
First Posted : August 21, 2014
Results First Posted : October 19, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: 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 19 August 2014 to 06 November 2014 at 2 clinical sites in the United States.
Pre-assignment Details A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in the study.
Arm/Group Title 6 to < 36 Months of Age 3 to < 9 Years of Age
Hide Arm/Group Description Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine. Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
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 Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine. Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine. 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
Age Continuous Number Analyzed 30 participants 30 participants 60 participants
25.0  (8.3) 66.9  (21.8) 45.9  (26.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
15
  50.0%
17
  56.7%
32
  53.3%
Male
15
  50.0%
13
  43.3%
28
  46.7%
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 Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Hide Description

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

Grade 3: Fever, > 39.5˚C (6 to < 36 months), ≥ 39.0˚C (3 to < 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity.

Time Frame Day 0 up to Day 7 post-any injection
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:
Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Percentage of participants
Injection-site Tenderness (N=30, 0) 70.0 NA [1] 
Grade 3 Injection-site Tenderness (N=30, 0) 3.3 NA [1] 
Injection site Pain (N=0, 30) NA [1]  73.3
Grade 3 Injection site Pain (N=0, 30) NA [1]  10
Injection-site Erythema 50.0 66.7
Grade 3 Injection-site Erythema 0.0 0.0
Injection-site Swelling 23.3 43.3
Grade 3 Injection site Swelling (6 to <36 months) 0.0 0.0
Fever 20.7 3.3
Grade 3 Fever 0.0 0.0
Vomiting (N=30, 0) 16.7 NA [1] 
Grade 3 Vomiting (N=30, 0) 0.0 NA [1] 
Crying abnormal (N=30, 0) 33.3 NA [1] 
Grade 3 Crying abnormal (N=30, 0) 0.0 NA [1] 
Drowsiness (N=30, 0) 30.0 NA [1] 
Grade 3 Drowsiness (N=30, 0) 0.0 NA [1] 
Appetite lost (N=30, 0) 26.7 NA [1] 
Grade 3 Appetite lost 0.0 NA [1] 
Irritability (N=30, 0) 53.3 NA [1] 
Grade 3 Irritability (N=30, 0) 0.0 NA [1] 
Headache (N=0, 30) NA [1]  10
Grade 3 Headache (N=0, 30) NA [1]  0
Malaise (N=0, 30) NA [1]  13.3
Grade 3 Malaise (N=0, 30) NA [1]  0
Myalgia (N=0, 30) NA [1]  13.3
Grade 3 Myalgia (N=0, 30) NA [1]  0
[1]
Event was not assessed in this group
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Hide Description Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
Time Frame Day 0 (pre-vaccination) and Day 28 post-final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean 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:
Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Overall Number of Participants Analyzed 29 29
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
A/H1N1; Pre-vaccination
32.6
(16.4 to 64.9)
361
(179 to 727)
A/H1N1; Post-vaccination
447
(254 to 787)
1235
(793 to 1924)
A/H3N2; Pre-vaccination
55.9
(25.7 to 121)
277
(162 to 473)
A/H3N2; Post-vaccination
696
(416 to 1165)
1250
(861 to 1814)
B (Yamagata); Pre-vaccination
56.6
(30.3 to 106)
281
(158 to 497)
B (Yamagata); Post-vaccination
617
(342 to 1115)
1425
(972 to 2090)
B (Victoria); Pre-vaccination
12.5
(6.88 to 22.9)
156
(85.9 to 284)
B (Victoria); Post-vaccination
352
(203 to 612)
1136
(706 to 1828)
3.Secondary Outcome
Title Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Hide Description Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.
Time Frame Day 0 (pre-vaccination) and Day 28 post-final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was 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:
Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Overall Number of Participants Analyzed 29 29
Measure Type: Number
Unit of Measure: Percentage of participants
A/H1N1; Pre-vaccination 44.8 86.2
A/H1N1; Post-vaccination 93.1 96.6
A/H3N2; Pre-vaccination 62.1 93.1
A/H3N2; Post-vaccination 96.6 100.0
B (Yamagata); Pre-vaccination 55.2 89.7
B (Yamagata); Post-vaccination 100.0 100.0
B (Victoria); Pre-vaccination 17.2 82.8
B (Victoria); Post-vaccination 100.0 100.0
4.Secondary Outcome
Title Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Hide Description Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.
Time Frame Day 28 post-final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was 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:
Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Overall Number of Participants Analyzed 29 29
Measure Type: Number
Unit of Measure: Percentage of participants
A/H1N1 86.2 34.5
A/H3N2 89.7 58.6
B (Yamagata) 86.2 58.6
B (Victoria) 89.7 69.0
5.Secondary Outcome
Title Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Hide Description Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
Time Frame Day 28 post-final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios 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:
Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
Overall Number of Participants Analyzed 29 29
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratio
A/H1N1
10.9
(6.61 to 18.0)
3.30
(2.14 to 5.11)
A/H3N2
10.4
(6.59 to 16.4)
4.51
(3.09 to 6.58)
B (Yamagata)
10.0
(6.35 to 15.9)
5.02
(3.43 to 7.34)
B (Victoria)
18.9
(11.6 to 30.8)
7.10
(4.71 to 10.7)
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any 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 Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine. Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
All-Cause Mortality
6 to < 36 Months of Age 3 to < 9 Years of Age
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
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%)    
Infections and infestations     
Abscess neck * 1  1/30 (3.33%)  1 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 16.0
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%)      22/30 (73.33%)    
Eye disorders     
Conjunctivitis * 1  2/30 (6.67%)  2 0/30 (0.00%)  0
Gastrointestinal disorders     
Vomiting  1  5/30 (16.67%)  5 0/30 (0.00%)  0
General disorders     
Pyrexia * 1  3/30 (10.00%)  3 1/30 (3.33%)  1
Injection site Tenderness  1  21/30 (70.00%)  21 0/30 (0.00%)  0
Injection site Erythema  1  15/30 (50.00%)  15 20/30 (66.67%)  20
Injection site Swelling  1  7/30 (23.33%)  7 13/30 (43.33%)  13
Fever  1  6/29 (20.69%)  6 1/30 (3.33%)  1
Injection site Pain  1  0/30 (0.00%)  0 22/30 (73.33%)  22
Malaise  1  0/30 (0.00%)  0 4/30 (13.33%)  4
Infections and infestations     
Otitis media acute * 1  3/30 (10.00%)  3 2/30 (6.67%)  2
Metabolism and nutrition disorders     
Appetite lost  1  8/30 (26.67%)  8 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  0/30 (0.00%)  0 2/30 (6.67%)  2
Myalgia  1  0/30 (0.00%)  0 4/30 (13.33%)  4
Nervous system disorders     
Drowsiness  1  9/30 (30.00%)  9 0/30 (0.00%)  0
Headache  1  0/30 (0.00%)  0 3/30 (10.00%)  3
Psychiatric disorders     
Crying abnormal  1  10/30 (33.33%)  10 0/30 (0.00%)  0
Irritability  1  16/30 (53.33%)  16 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/30 (6.67%)  3 5/30 (16.67%)  5
Rhinorrhoea * 1  3/30 (10.00%)  3 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 version 16.0
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: NCT02222870    
Other Study ID Numbers: GRC56
U1111-1143-8966 ( Other Identifier: WHO )
First Submitted: August 20, 2014
First Posted: August 21, 2014
Results First Submitted: September 16, 2015
Results First Posted: October 19, 2015
Last Update Posted: October 19, 2015