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Trial record 1 of 1 for:    GRC51
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Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine

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ClinicalTrials.gov Identifier: NCT01946425
Recruitment Status : Completed
First Posted : September 19, 2013
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
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 Virus Vaccine, No Preservative
Enrollment 60
Recruitment Details The study participants were enrolled from 16 September 2013 to 10 October 2013 at 2 clinic centers in the United States.
Pre-assignment Details A total of 60 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in this study.
Arm/Group Title Age 6 Months to <36 Months Group Age 3 Years to <9 Years Group
Hide Arm/Group Description Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation) Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
Period Title: Overall Study
Started 30 30
Completed 28 30
Not Completed 2 0
Reason Not Completed
Protocol Violation             1             0
Withdrawal by Subject             1             0
Arm/Group Title Age 6 to <36 Months Group Age 3 to <9 Years Group Total
Hide Arm/Group Description Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation) Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation) 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:  Years
Age Continuous Number Analyzed 30 participants 30 participants 60 participants
1.9  (0.6) 5.4  (1.8) 3.7  (2.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
16
  53.3%
19
  63.3%
35
  58.3%
Male
14
  46.7%
11
  36.7%
25
  41.7%
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 Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
Hide Description

Solicited injection-site reactions (6 months to <36 months of age): Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite loss, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥50 mm; Fever, >103.1ºF; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.

Solicited injection-site reactions (3 years to < 9 years of age): Pain, Erythema, and Swelling. Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm; Fever, ≥102.1ºF; Headache, Malaise, and Myalgia, Significant, prevents daily activity.

Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all participants who received at least one dose of study vaccine.
Arm/Group Title Age 6 Months to <36 Months Group Age 3 Years to <9 Years Group
Hide Arm/Group Description:
Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
Overall Number of Participants Analyzed 29 30
Measure Type: Number
Unit of Measure: Participants
Injection-site tenderness 20 NA [1] 
Grade 3 Injection-site tenderness 5 NA [1] 
Injection-site erythema 15 10
Grade 3 Injection-site erythema 0 1
Injection-site swelling 7 7
Grade 3 Injection-site swelling 0 1
Injection-site pain NA [2]  21
Grade 3 Injection-site pain NA [2]  1
Fever 6 2
Grade 3 Fever 0 0
Vomiting 4 NA [3] 
Grade 3 Vomiting 0 NA [3] 
Crying abnormal 10 NA [3] 
Grade 3 Crying abnormal 3 NA [3] 
Drowsiness 8 NA [3] 
Grade 3 Drowsiness 1 NA [3] 
Appetite lost 7 NA [3] 
Grade 3 Appetite lost 2 NA [3] 
Irritability 17 NA [3] 
Grade 3 Irritability 3 NA [3] 
Headache NA [3]  4
Grade 3 Headache NA [3]  1
Malaise NA [3]  11
Grade 3 Malaise NA [3]  0
Myalgia NA [3]  13
Grade 3 Myalgia NA [3]  1
[1]
This injection-site reaction was not solicited in this group
[2]
This injection-site reaction was not solicited in this group.
[3]
This systemic reaction was not solicited in this group.
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
Hide Description Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.
Time Frame Day 0 (pre-vaccination) and Day 28 after final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers of antibodies against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Age 6 Months to <36 Months Group Age 3 Years to <9 Years Group
Hide Arm/Group Description:
Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
Overall Number of Participants Analyzed 26 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 (pre-vaccination; N = 25, 28)
14.1
(7.76 to 25.8)
136
(68.4 to 271)
A/H1N1 (post-vaccination; N = 26, 28)
245
(132 to 455)
1264
(930 to 1719)
A/H3N2 (pre-vaccination; N = 25, 28)
23.6
(12.5 to 44.8)
215
(109 to 427)
A/H3N2 (post-vaccination; N = 26, 28)
484
(287 to 817)
1103
(788 to 1544)
B Yamagata (pre-vaccination; N = 25, 28)
6.24
(4.94 to 7.88)
29.0
(18.3 to 45.8)
B Yamagata (post-vaccination; N = 26, 28)
48.2
(26.7 to 87.1)
162
(114 to 231)
B Victoria (pre-vaccination; N = 25, 28)
5.99
(4.76 to 7.54)
13.1
(8.61 to 20.0)
B Victoria (post-vaccination; N = 26, 28)
24.8
(12.7 to 48.1)
113
(72.8 to 176)
3.Secondary Outcome
Title Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
Hide Description Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).
Time Frame Day 0 (pre-vaccination) and Day 28 after final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Age 6 Months to <36 Months Group Age 3 Years to <9 Years Group
Hide Arm/Group Description:
Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
Overall Number of Participants Analyzed 26 28
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (pre-vaccination; N = 25, 28) 5 19
A/H1N1 (post-vaccination; N = 26, 28) 22 28
A/H3N2 (pre-vaccination; N = 25, 28) 8 24
A/H3N2 (post-vaccination; N = 26, 28) 24 28
B Yamagata (pre-vaccination; N = 25, 28) 1 16
B Yamagata (post-vaccination; N = 26, 28) 18 27
B Victoria (pre-vaccination; N = 25, 28) 1 6
B Victoria (post-vaccination; N = 26, 28) 8 22
4.Secondary Outcome
Title Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
Hide Description Influenza virus antibodies were measured using an HAI assay. Seroconversion was 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 0 (pre-vaccination) and Day 28 after final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Age 6 Months to <36 Months Group Age 3 Years to <9 Years Group
Hide Arm/Group Description:
Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
Overall Number of Participants Analyzed 26 28
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (N = 25, 28) 20 19
A/H3N2 (N = 25, 28) 22 14
B Yamagata (N = 25, 28) 17 17
B Victoria (N = 25, 28) 8 17
5.Secondary Outcome
Title Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
Hide Description Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccine.
Time Frame Day 0 (pre-vaccination) and Day 28 after final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Age 6 Months to <36 Months Group Age 3 Years to <9 Years Group
Hide Arm/Group Description:
Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
Overall Number of Participants Analyzed 26 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer Ratio
A/H1N1 (N = 25, 28)
13.9
(8.33 to 23.3)
8.83
(4.95 to 15.7)
A/H3N2 (N = 25, 28)
15.8
(9.43 to 26.4)
4.82
(2.99 to 7.75)
B Yamagata (N = 25, 28)
5.13
(3.06 to 8.61)
4.70
(3.20 to 6.90)
B Victoria (N = 25, 28)
2.87
(1.72 to 4.79)
6.17
(4.17 to 9.13)
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Age 6 Months to <36 Months Group Age 3 Years to <9 Years Group
Hide Arm/Group Description Participants 6 months to < 36 months of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation) Participants age 3 years to < 9 years of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation)
All-Cause Mortality
Age 6 Months to <36 Months Group Age 3 Years to <9 Years Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Age 6 Months to <36 Months Group Age 3 Years to <9 Years Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Age 6 Months to <36 Months Group Age 3 Years to <9 Years Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/30 (70.00%)      21/30 (70.00%)    
Gastrointestinal disorders     
Diarrhoea * 1  2/30 (6.67%)  2 1/30 (3.33%)  1
Vomiting  1  4/29 (13.79%)  4 0/0  0
General disorders     
Injection-site tenderness  1  20/29 (68.97%)  20 0/0  0
Injection-site erythema  1  15/29 (51.72%)  15 10/30 (33.33%)  10
Injection-site swelling  1  7/29 (24.14%)  7 7/30 (23.33%)  7
Fever  1  6/29 (20.69%)  6 2/30 (6.67%)  2
Injection-site pain  1  0/0  0 21/30 (70.00%)  21
Malaise  1  0/0  0 11/30 (36.67%)  11
Infections and infestations     
Croup infectious * 1  1/30 (3.33%)  1 2/30 (6.67%)  2
Sinusitis * 1  0/30 (0.00%)  0 2/30 (6.67%)  2
Upper respiratory tract infection * 1  7/30 (23.33%)  8 2/30 (6.67%)  3
Metabolism and nutrition disorders     
Appetite lost  1  7/29 (24.14%)  7 0/0  0
Musculoskeletal and connective tissue disorders     
Myalgia  1  0/0  0 13/30 (43.33%)  13
Nervous system disorders     
Drowsiness  1  8/29 (27.59%)  8 0/0  0
Headache  1  0/0  0 4/30 (13.33%)  4
Psychiatric disorders     
Crying abnormal  1  10/29 (34.48%)  10 0/0  0
Irritability  1  17/29 (58.62%)  17 0/0  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  3/30 (10.00%)  3 1/30 (3.33%)  1
Rhinorrhoea * 1  2/30 (6.67%)  2 3/30 (10.00%)  3
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
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01946425     History of Changes
Other Study ID Numbers: GRC51
U1111-1120-1262 ( Other Identifier: WHO )
First Submitted: September 16, 2013
First Posted: September 19, 2013
Results First Submitted: September 17, 2014
Results First Posted: September 25, 2014
Last Update Posted: September 25, 2014