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Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

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ClinicalTrials.gov Identifier: NCT00390884
Recruitment Status : Completed
First Posted : October 23, 2006
Results First Posted : December 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: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Influenza Virus Vaccine, Fluzone®
Enrollment 173
Recruitment Details Participants were enrolled into this study from 03 October 2006 to 04 January 2007 at 5 US clinical centers.
Pre-assignment Details A total of 173 participants were enrolled, vaccinated, and analyzed.
Arm/Group Title Fluzone®-Primed Group Fluzone®-Naive Group
Hide Arm/Group Description Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Period Title: Overall Study
Started 116 57
Completed 114 55
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             2             2
Arm/Group Title Fluzone®-Primed Group Fluzone®-Naive Group Total
Hide Arm/Group Description Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. Total of all reporting groups
Overall Number of Baseline Participants 116 57 173
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 57 participants 173 participants
<=18 years
116
 100.0%
57
 100.0%
173
 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 116 participants 57 participants 173 participants
13.8  (1.01) 13.9  (1.13) 13.8  (1.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 57 participants 173 participants
Female
48
  41.4%
22
  38.6%
70
  40.5%
Male
68
  58.6%
35
  61.4%
103
  59.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 116 participants 57 participants 173 participants
116 57 173
1.Primary Outcome
Title Percentage of Seroprotected Participants Post-vaccination With Fluzone®
Hide Description Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.
Time Frame Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Hemagglutination inhibition titers to the Fluzone® vaccine antigens were assessed in the per-protocol immunogenicity population.
Arm/Group Title Fluzone®-Primed Group Fluzone®-Naive Group
Hide Arm/Group Description:
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Overall Number of Participants Analyzed 94 50
Measure Type: Number
Unit of Measure: Percentage of Participants
Flu A/New Caledonia/20/99 (H1N1) Post-Dose 1 59 34
Flu A/Wisconsin/67/2005 (H3N2) Post -Dose 1 95 80
Flu B/Malaysia/2506/2004 Post-Dose 1 10 6
Flu A/New Caledonia/20/99 (H1N1) Post-Dose 2 62 82
Flu A/Wisconsin/67/2005 (H3N2) Post -Dose 2 79 94
Flu B/Malaysia/2506/2004 Post-Dose 2 50 65
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
Hide Description Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.
Time Frame Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Geometric Mean Titers were analyzed in the per-protocol immunogenicity population
Arm/Group Title Fluzone®-Primed Group Fluzone®-Naive Group
Hide Arm/Group Description:
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Overall Number of Participants Analyzed 94 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/New Caledonia/20/99 (H1N1) Post-Dose 1
41.3
(32.9 to 52.0)
22.7
(17.9 to 28.7)
Flu A/Wisconsin/67/2005 (H3N2) Post-Dose 1
144
(116 to 179)
89.4
(55.4 to 144)
Flu B/Malaysia/2506/2004 Post-Dose 1
11.1
(8.45 to 14.6)
9.27
(6.31 to 13.6)
Flu A/New Caledonia/20/99 (H1N1) Post-Dose 2
42.1
(27.3 to 64.8)
78.4
(47.1 to 131)
Flu A/Wisconsin/67/2005 (H3N2) Post-Dose 2
103
(68.9 to 155)
217
(122 to 388)
Flu B/Malaysia/2506/2004 Post-Dose 2
39.2
(25.5 to 60.3)
63.9
(34.9 to 117)
3.Other Pre-specified Outcome
Title Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Hide Description Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination
Time Frame Days 0-7 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
Arm/Group Title Fluzone®-Primed Group Fluzone®-Naive Group
Hide Arm/Group Description:
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Overall Number of Participants Analyzed 116 57
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Injection Site Reaction Post-Dose 1 51 55
Any Tenderness 46 55
Grade 3 Tenderness (Crying when limb is moved) 0 0
Any Redness (> 0.5 cm) 7 7
Grade 3 Redness (≥ 5.0 cm) 0 0
Any Swelling (> 0.5 cm) 5 7
Grade 3 Swelling (≥ 5.0 cm) 0 0
Any Injection Site Reaction Post-Dose 2 57 51
Any Tenderness 56 49
Grade 3 Tenderness (Crying when limb is moved) 1 0
Any Redness (> 0.5 cm) 7 6
Grade 3 Redness (≥ 5.0 cm) 0 0
Any Swelling (> 0.5 cm) 4 0
Grade 3 Swelling (≥ 5.0 cm) 0 0
Any Injection Site Reaction - Any Dose 68 69
Any Tenderness 65 69
Grade 3 Tenderness (Crying when limb is moved) 1 0
Any Redness (> 0.5 cm) 13 11
Grade 3 Redness (≥ 5.0 cm) 0 0
Any Swelling (> 0.5 cm) 6 7
Grade 3 Swelling (≥ 5.0 cm) 0 0
Any Systemic Reaction Post-Dose 1 75 76
Any Fever 16 11
Grade 3 Fever (≥ 103.2 ºF) 0 0
Any Vomiting 13 16
Grade 3 Vomiting (≥ 6 episodes per 24 hours) 0 0
Any Abnormal Crying 42 36
Grade 3 Abnormal Crying (> 3 hours) 0 0
Any Drowsiness 32 31
Grade 3 Drowsiness (Slept most of time) 0 2
Any Loss of Appetite 38 33
Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) 2 2
Any Irritability 66 64
Grade 3 Irritability (Inconsolable) 2 0
Any Systemic Reaction Post-Dose 2 72 71
Any Fever 17 15
Grade 3 Fever (≥ 103.2 ºF) 2 2
Any Vomiting 12 16
Grade 3 Vomiting (≥ 6 episodes per 24 hours) 2 0
Any Abnormal Crying 39 33
Grade 3 Abnormal Crying (> 3 hours) 3 0
Any Drowsiness 32 33
Grade 3 Drowsiness (Slept most of time) 1 0
Any Loss of Appetite 32 33
Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) 5 0
Any Irritability 57 60
Grade 3 Irritability (Inconsolable) 4 0
Any Systemic Reaction - Any Dose 88 89
Any Fever 29 24
Grade 3 Fever (≥ 103.2 ºF) 2 2
Any Vomiting 21 29
Grade 3 Vomiting (≥ 6 episodes per 24 hours) 2 0
Any Abnormal Crying 55 53
Grade 3 Abnormal Crying (> 3 hours) 3 0
Any Drowsiness 46 47
Grade 3 Drowsiness (Slept most of time) 1 2
Any Loss of Appetite 53 51
Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) 5 2
Any Irritability 74 78
Grade 3 Irritability (Inconsolable) 5 0
Time Frame Adverse event data were collected for 2 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluzone®-Primed Group Fluzone®-Naive Group
Hide Arm/Group Description Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
All-Cause Mortality
Fluzone®-Primed Group Fluzone®-Naive Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone®-Primed Group Fluzone®-Naive Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/116 (0.86%)      0/57 (0.00%)    
Infections and infestations     
Gastroenteritis * 1  1/116 (0.86%)  1 0/57 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluzone®-Primed Group Fluzone®-Naive Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   87/116 (75.00%)      40/57 (70.18%)    
Gastrointestinal disorders     
Diarrhoea * 1  23/116 (19.83%)  27 13/57 (22.81%)  14
Teething * 1  20/116 (17.24%)  30 5/57 (8.77%)  6
Vomiting * 1  17/116 (14.66%)  17 5/57 (8.77%)  5
General disorders     
Pyrexia * 1  19/116 (16.38%)  20 11/57 (19.30%)  12
Infections and infestations     
Croup infectious * 1  7/116 (6.03%)  7 1/57 (1.75%)  1
Nasopharyngitis * 1  13/116 (11.21%)  15 6/57 (10.53%)  6
Otitis media * 1  26/116 (22.41%)  28 9/57 (15.79%)  10
Upper respiratory tract infection * 1  24/116 (20.69%)  31 9/57 (15.79%)  9
Respiratory, thoracic and mediastinal disorders     
Cough * 1  22/116 (18.97%)  25 15/57 (26.32%)  17
Nasal congestion * 1  7/116 (6.03%)  7 5/57 (8.77%)  5
Rhinorrhoea * 1  21/116 (18.10%)  25 6/57 (10.53%)  7
Skin and subcutaneous tissue disorders     
Rash * 1  3/116 (2.59%)  3 3/57 (5.26%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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: NCT00390884     History of Changes
Other Study ID Numbers: GRC29
First Submitted: October 20, 2006
First Posted: October 23, 2006
Results First Submitted: September 21, 2009
Results First Posted: December 31, 2009
Last Update Posted: April 14, 2016