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Trial record 46 of 597 for:    Fluzone® | Studies With Results

Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age

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ClinicalTrials.gov Identifier: NCT00858468
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : July 31, 2009
Last Update Posted : April 14, 2016
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: Influenza virus vaccine (2004-2005 Formulation)
Enrollment 394

Recruitment Details Participants were enrolled from 08 April to 05 August 2005 in 8 medical centers in the US
Pre-assignment Details A total of 394 participants that met the inclusion and exclusion criteria were enrolled, 393 were vaccinated.
Arm/Group Title Age 6 to 12 Weeks Age 24 to 36 Weeks
Hide Arm/Group Description Participants enrolled at 6 to 12 weeks of age Participants enrolled at 24 to 36 weeks of age
Period Title: Overall Study
Started 201 [1] 192
Completed 201 192
Not Completed 0 0
[1]
1 enrolled participant was not vaccinated and removed from analysis
Arm/Group Title Age 6 to 12 Weeks Age 24 to 36 Weeks Total
Hide Arm/Group Description Participants enrolled at 6 to 12 weeks of age Participants enrolled at 24 to 36 weeks of age Total of all reporting groups
Overall Number of Baseline Participants 201 192 393
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 192 participants 393 participants
<=18 years
201
 100.0%
192
 100.0%
393
 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:  Weeks
Number Analyzed 201 participants 192 participants 393 participants
9.4  (0.98) 27.0  (1.31) 18.0  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 192 participants 393 participants
Female
98
  48.8%
99
  51.6%
197
  50.1%
Male
103
  51.2%
93
  48.4%
196
  49.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 201 participants 192 participants 393 participants
201 192 393
1.Primary Outcome
Title Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
Hide Description Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
Time Frame Day 0 to Day 7 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intend-to-treat population
Arm/Group Title Age 6 to 12 Weeks Age 24 to 36 Weeks
Hide Arm/Group Description:
Participants enrolled at 6 to 12 weeks of age
Participants enrolled at 24 to 36 weeks of age
Overall Number of Participants Analyzed 201 192
Measure Type: Number
Unit of Measure: Percentage of participants
Any Solicited Injection Site Reaction - Dose 1 54 47
Any Tenderness 50 44
Grd 3 Tenderness-Inj. Limb movement reduced 6 2
Any Redness 11 7
Grade 3 Redness (≥ 5.0 cm) 0 0
Any Swelling 8 5
Grade 3 Swelling (≥ 5.0 cm) 0 0
Any Solicited Injection Site Reaction - Dose 2 41 27
Any Tenderness 38 26
Grd 3 Tenderness-Inj. Limb movement reduced 1 0
Any Redness 10 5
Grade 3 Redness (≥ 5.0 cm) 1 0
Any Swelling 5 2
Grade 3 Swelling (≥5.0 cm) 0 0
Any Solicited Injection Site Reaction - Any Doses 61 52
Any Tenderness 57 50
Grd 3 Tenderness-Inj. Limb movement reduced 7 2
Any Redness 16 10
Grade 3 Redness (≥ 5.0 cm) 1 0
Any Swelling 12 6
Grade 3 Swelling (≥ 5.0 cm) 0 0
Any Solicited Systemic Reaction Dose 1 90 82
Any Fever (Rectal Temp) 8 18
Grade 3 Fever (>39.5 ºC) 0 0
Any Vomiting 22 16
Grade 3 Vomiting (≥ 6 episodes per 24 hrs) 1 0
Any Abnormal Crying 59 45
Grade 3 Abnormal Crying 3 3
Any Drowsiness 72 50
Grade 3 Drowsiness (difficulty waking up) 2 1
Any Loss of Appetite 43 35
Grd 3 Loss of Appetite (refuses ≥ 3 meals) 0 2
Any Irritability 77 67
Grade 3 Irritability (inconsolable) 5 3
Any Solicited Systemic Reaction Dose 2 70 70
Any Fever (Rectal Temp) 4 14
Grade 3 Fever (>39.5 ºC) 0 2
Any Vomiting 14 8
Grade 3 Vomiting (≥ 6 episodes per 24 hrs) 1 0
Any Abnormal Crying 37 34
Grade 3 Abnormal Crying 4 1
Any Drowsiness 47 38
Grade 3 Drowsiness (difficulty waking up) 2 0
Any Loss of Appetite 28 27
Grade 3 Loss of Appetite (refuses ≥ 3 meals) 1 0
Any Irritability 55 53
Grade 3 Irritability (inconsolable) 3 1
Any Solicited Systemic Reaction Any Dose 92 89
Any Fever (Rectal Temp) 11 26
Grade 3 Fever (>39.5 ºC) 0 2
Any Vomiting 27 21
Grade 3 Vomiting (≥ 6 episodes per 24 hrs) 2 0
Any Abnormal Crying 66 55
Grade 3 Abnormal Crying 6 4
Any Drowsiness 78 58
Grade 3 Drowsiness (difficulty waking up) 4 1
Any Loss of Appetite 52 47
Grade 3 Loss of Appetite (refuses ≥ 3 meals) 1 2
Any Irritability 82 76
Grade 3 Irritability (inconsolable) 7 4
2.Other Pre-specified Outcome
Title Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).
Hide Description

Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.

Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40

Time Frame 21 days post-vaccination 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Seroprotection analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.
Arm/Group Title Age 6 to 12 Weeks Age 24 to 36 Weeks
Hide Arm/Group Description:
Participants enrolled at 6 to 12 weeks of age
Participants enrolled at 24 to 36 weeks of age
Overall Number of Participants Analyzed 149 144
Measure Type: Number
Unit of Measure: Percentage of participants
A/NEW CALEDONIA/20/99 ≥ 40 Post-dose 46 69
A/WYOMING/03/2003 ≥ 40 Post-dose 59 78
B/JIANGSU/10/2003 ≥ 40 Post-dose 5 22
3.Other Pre-specified Outcome
Title Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion).
Hide Description Seroconversion was defined as the percentage of participants with a pre-titer < 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination.
Time Frame 21 days post-vaccination 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Seroconversion analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.
Arm/Group Title Age 6 to 12 Weeks Age 24 to 36 Weeks
Hide Arm/Group Description:
Participants enrolled at 6 to 12 weeks of age
Participants enrolled at 24 to 36 weeks of age
Overall Number of Participants Analyzed 149 144
Measure Type: Number
Unit of Measure: Percentage of participants
A/NEW CALEDONIA/20/99, Pre-Dose ≤ 10 70 96
A/NEW CALEDONIA/20/99, Pre-Dose ≤10, Post-Dose ≥40 48 72
A/WYOMING/03/2003, Pre-Dose ≤ 10 32 74
A/WYOMING/03/2003, Pre-Dose ≤10, Post-Dose ≥40 60 86
FLU B/JIANGSU/10/2003, Pre-Dose ≤ 10 84 97
FLU B/JIANGSU/10/2003, Pre-Dose ≤10, Post-Dose ≥40 4 20
4.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.
Hide Description Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.
Time Frame 21 days post-vaccination 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
GMTs were assessed on the Per-Protocol Population
Arm/Group Title Age 6 to 12 Weeks Age 24 to 36 Weeks
Hide Arm/Group Description:
Participants enrolled at 6 to 12 weeks of age
Participants enrolled at 24 to 36 weeks of age
Overall Number of Participants Analyzed 149 144
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/NEW CALEDONIA/20/99 Pre-dose
11.5
(9.4 to 14.1)
5.7
(5.3 to 6.0)
A/NEW CALEDONIA/20/99 Post-dose
27.6
(23.1 to 33.1)
47.0
(39.3 to 56.2)
A/WYOMING/03/2003 Pre-dose
40.8
(31.2 to 53.2)
9.8
(8.1 to 11.9)
A/WYOMING/03/2003 Post-dose
46.3
(38.7 to 55.4)
90.9
(72.2 to 114.4)
B/JIANGSU/10/2003 Pre-dose
7.0
(6.3 to 7.8)
5.4
(5.1 to 5.7)
B/JIANGSU/10/2003 Post-dose
8.4
(7.5 to 9.3)
15.3
(12.9 to 18.2)
Time Frame Adverse event data were collected for 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Age 6 to 12 Weeks Age 24 to 36 Weeks
Hide Arm/Group Description Participants enrolled at 6 to 12 weeks of age Participants enrolled at 24 to 36 weeks of age
All-Cause Mortality
Age 6 to 12 Weeks Age 24 to 36 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Age 6 to 12 Weeks Age 24 to 36 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/201 (1.99%)      3/192 (1.56%)    
Gastrointestinal disorders     
Viral gastroenteritis * 1  0/201 (0.00%)  0 1/192 (0.52%)  1
Infections and infestations     
Kawasaki’s disease * 1  1/201 (0.50%)  1 0/192 (0.00%)  0
Cellulitis * 1  0/201 (0.00%)  0 1/192 (0.52%)  1
Fever * 1  1/201 (0.50%)  1 0/192 (0.00%)  0
Nervous system disorders     
Febrile convulsion * 1  0/201 (0.00%)  0 1/192 (0.52%)  3
Respiratory, thoracic and mediastinal disorders     
Choking * 1  1/201 (0.50%)  1 0/192 (0.00%)  0
Bronchiolitis * 1  1/201 (0.50%)  1 0/192 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Age 6 to 12 Weeks Age 24 to 36 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/201 (26.87%)      94/192 (48.96%)    
Gastrointestinal disorders     
Diarrhoea * 1  10/201 (4.98%)  11 12/192 (6.25%)  13
Teething * 1  0/201 (0.00%)  0 17/192 (8.85%)  22
General disorders     
Injection site haemorrhage * 1  4/201 (1.99%)  5 10/192 (5.21%)  11
Pyrexia * 1  5/201 (2.49%)  6 19/192 (9.90%)  20
Infections and infestations     
Nasopharyngitis * 1  2/201 (1.00%)  2 11/192 (5.73%)  12
Otitis media * 1  3/201 (1.49%)  3 16/192 (8.33%)  18
Upper respiratory tract infection * 1  13/201 (6.47%)  13 19/192 (9.90%)  20
Respiratory, thoracic and mediastinal disorders     
Cough * 1  8/201 (3.98%)  8 16/192 (8.33%)  17
Nasal congestion * 1  13/201 (6.47%)  14 3/192 (1.56%)  3
Rhinorrhoea * 1  9/201 (4.48%)  10 15/192 (7.81%)  17
Skin and subcutaneous tissue disorders     
Rash * 1  4/201 (1.99%)  5 10/192 (5.21%)  11
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
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: NCT00858468     History of Changes
Other Study ID Numbers: GRC27
First Submitted: March 5, 2009
First Posted: March 9, 2009
Results First Submitted: April 20, 2009
Results First Posted: July 31, 2009
Last Update Posted: April 14, 2016