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Trial record 1 of 1 for:    GRC49
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Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)

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ClinicalTrials.gov Identifier: NCT01691326
Recruitment Status : Completed
First Posted : September 24, 2012
Results First Posted : April 16, 2014
Last Update Posted : April 16, 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
Interventions Biological: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose
Biological: Fluzone®; Influenza Virus Vaccine, No Preservative
Enrollment 60
Recruitment Details The study participants were enrolled from 19 September 2012 to 12 December 2012 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 randomized and vaccinated in this study.
Arm/Group Title Age 6 to < 36 Months Group Age 3 to < 9 Years Group
Hide Arm/Group Description Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine Participants 3 years to < 9 years of age that received one or two doses 0.5 mL of Fluzone vaccine
Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 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 that received one or two doses of 0.25 mL of Fluzone vaccine Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone 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:  Years
Number Analyzed 30 participants 30 participants 60 participants
1.8  (0.6) 5.2  (1.6) 3.5  (1.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
14
  46.7%
13
  43.3%
27
  45.0%
Male
16
  53.3%
17
  56.7%
33
  55.0%
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 Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Hide Description

Solicited injection site reactions (Age 6 to < 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.

Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, >103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, >3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable.

Solicited injection site reactions (Age 24 Months to < 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; 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 persons who received at least one dose of study vaccine.
Arm/Group Title Age 6 to < 36 Months Group Age 3 to < 9 Years Group
Hide Arm/Group Description:
Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Participants
Injection site Tenderness (N = 15, 0) 8 NA [1] 
Grade 3 Injection site Tenderness (N =15, 0) 1 NA [1] 
Injection site Pain (N =15, 30) 8 13
Grade 3 Injection site Pain (N = 15, 30) 0 0
Injection site Erythema (N = 30, 30) 8 9
Grade 3 Injection site Erythema (N = 30, 30) 0 0
Injection site Swelling (N = 30, 30) 5 7
Grade 3 Injection site Swelling (N = 30, 30) 0 0
Fever (N = 30, 28) 2 0
Grade 3 Fever (N = 30, 28) 0 0
Headache (N = 15, 30) 1 5
Grade 3 Headache (N = 15, 30) 0 0
Malaise (N = 15, 30) 4 4
Grade 3 Malaise (N = 15, 30) 0 0
Myalgia (N = 15, 30) 3 2
Grade 3 Myalgia (N = 15, 30) 0 0
Vomiting (N = 15, 0) 1 NA [2] 
Grade 3 Vomiting (N = 15, 0) 0 NA [2] 
Abnormal crying (N = 15, 0) 6 NA [3] 
Grade 3 Abnormal crying (N = 15, 0) 0 NA [3] 
Drowsiness (N = 15, 0) 5 NA [4] 
Grade 3 Drowsiness (N = 15, 0) 0 NA [4] 
Loss of Appetite (N = 15, 0) 4 NA [5] 
Grade 3 Loss of Appetite (N = 15, 0) 0 NA [5] 
Irritability (N = 15, 0) 9 NA [6] 
Grade 3 Irritability (N = 15, 0) 1 NA [6] 
[1]
Injection site Tenderness was not solicited in this group
[2]
Vomiting was not solicited in this group
[3]
Abnormal crying was not solicited in this group
[4]
Drowsiness was not solicited in this group
[5]
Loss of Appetite was not solicited in this group
[6]
Irritability was not solicited in this group
2.Other Pre-specified Outcome
Title Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).
Hide Description The 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 influenza virus antigens were assessed in the Per-protocol Analysis Set.
Arm/Group Title 6 to < 36 Months Age Group 3 to < 9 Years Age Group
Hide Arm/Group Description:
Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
Overall Number of Participants Analyzed 25 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 (pre-vaccination)
20.6
(9.93 to 42.6)
68.8
(30.5 to 155)
A/H1N1 (post-vaccination)
334
(189 to 589)
864
(559 to 1337)
A/H3N2 (pre-vaccination)
23.3
(11.4 to 47.5)
84.8
(49.5 to 145)
A/H3N2 (post-vaccination)
506
(296 to 865)
895
(585 to 1369)
B (pre-vaccination)
5.82
(4.76 to 7.13)
9.66
(7.42 to 12.6)
B (post-vaccination)
16.7
(11.2 to 24.8)
69.6
(46.4 to 105)
3.Other Pre-specified Outcome
Title Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Hide Description Influenza virus antibodies were measured using a 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 influenza virus antigens were assessed in the Per-protocol Analysis Set.
Arm/Group Title Age 6 to < 36 Months Group Age 3 to < 9 Years Group
Hide Arm/Group Description:
Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
Overall Number of Participants Analyzed 25 30
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (pre-vaccination) 10 18
A/H1N1 (post-vaccination) 24 30
A/H3N2 (pre-vaccination) 11 20
A/H3N2 (post-vaccination) 25 30
B (pre-vaccination) 1 2
B (post-vaccination) 6 21
4.Other Pre-specified Outcome
Title Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Hide Description Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.
Time Frame Day 28 after final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion against the influenza virus antigens were assessed in the Per-protocol Analysis Set.
Arm/Group Title Age 6 to < 36 Months Group Age 3 to < 9 Years Group
Hide Arm/Group Description:
Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
Overall Number of Participants Analyzed 25 30
Measure Type: Number
Unit of Measure: Participants
A/H1N1 22 22
A/H3N2 23 25
B 5 20
5.Other Pre-specified Outcome
Title Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).
Hide Description Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens
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 influenza virus antigens were assessed in the Per-protocol Analysis Set.
Arm/Group Title Age 6 to < 36 Months Group Age 3 to < 9 Years Group
Hide Arm/Group Description:
Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
Overall Number of Participants Analyzed 25 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
A/H1N1
11.6
(7.24 to 18.7)
10.7
(5.56 to 20.5)
A/H3N2
16.2
(9.45 to 27.9)
10.3
(5.88 to 18.1)
B
1.82
(1.29 to 2.55)
5.34
(3.75 to 7.60)
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 6 to < 36 Months Age Group 3 to < 9 Years Age Group
Hide Arm/Group Description Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
All-Cause Mortality
6 to < 36 Months Age Group 3 to < 9 Years Age Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
6 to < 36 Months Age Group 3 to < 9 Years Age 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%
6 to < 36 Months Age Group 3 to < 9 Years Age Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/30 (30.00%)      13/30 (43.33%)    
Gastrointestinal disorders     
Diarrhoea * 1  4/30 (13.33%)  4 0/30 (0.00%)  0
Vomiting  1  1/15 (6.67%)  1 0/0  0
General disorders     
Pyrexia * 1  1/30 (3.33%)  1 2/30 (6.67%)  2
Injection site Tenderness  1  8/15 (53.33%)  8 0/0  0
Injection site Pain  1  8/15 (53.33%)  8 13/30 (43.33%)  13
Injection site Erythema  1  8/30 (26.67%)  8 9/30 (30.00%)  9
Injection site Swelling  1  5/30 (16.67%)  5 7/30 (23.33%)  7
Fever  1  2/30 (6.67%)  2 0/28 (0.00%)  0
Malaise  1  4/15 (26.67%)  4 4/30 (13.33%)  4
Infections and infestations     
Upper respiratory tract infection * 1  4/30 (13.33%)  5 0/30 (0.00%)  0
Metabolism and nutrition disorders     
Loss of Appetite  1  4/15 (26.67%)  4 0/0  0
Musculoskeletal and connective tissue disorders     
Myalgia  1  3/15 (20.00%)  3 2/30 (6.67%)  2
Nervous system disorders     
Drowsiness  1  5/15 (33.33%)  5 0/0  0
Headache  1  1/15 (6.67%)  1 5/30 (16.67%)  5
Psychiatric disorders     
Abnormal crying  1  6/15 (40.00%)  6 0/0  0
Irritability  1  9/15 (60.00%)  9 0/0  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/30 (6.67%)  3 2/30 (6.67%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0 version
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: NCT01691326     History of Changes
Other Study ID Numbers: GRC49
U1111-1124-8218 ( Other Identifier: WHO )
First Submitted: September 19, 2012
First Posted: September 24, 2012
Results First Submitted: January 24, 2014
Results First Posted: April 16, 2014
Last Update Posted: April 16, 2014