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Trial record 1 of 1 for:    GRC32
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Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age

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ClinicalTrials.gov Identifier: NCT00885105
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : January 1, 2010
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
Enrollment 242
Recruitment Details Participants were enrolled from 17 October 2005 to 05 January 2006 at 7 medical centers in the US.
Pre-assignment Details A total of 242 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group
Hide Arm/Group Description Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Period Title: Overall Study
Started 112 130
Completed 111 120
Not Completed 1 10
Reason Not Completed
Withdrawal by Subject             0             8
Adverse Event             1             0
Protocol Violation             0             2
Arm/Group Title Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group Total
Hide Arm/Group Description Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. Total of all reporting groups
Overall Number of Baseline Participants 112 130 242
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 130 participants 242 participants
<=18 years
112
 100.0%
130
 100.0%
242
 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 112 participants 130 participants 242 participants
7.29  (1.1) 7.28  (1.47) 7.28  (1.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 130 participants 242 participants
Female
53
  47.3%
60
  46.2%
113
  46.7%
Male
59
  52.7%
70
  53.8%
129
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 112 participants 130 participants 242 participants
112 130 242
1.Primary Outcome
Title Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.
Hide Description Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
Time Frame Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Hemagglutination inhibition titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.
Arm/Group Title Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group
Hide Arm/Group Description:
Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Overall Number of Participants Analyzed 51 51
Measure Type: Number
Unit of Measure: Percentage of Participants
A/New Caledonia/20/99 Post-Dose 1 44 34
A/New York/55/2004 Post-Dose 1 31 74
B/Jiangsu/310/2003 Post-Dose 1 22 6
A/New Caledonia/20/99 Post-Dose 2 69 86
A/New York/55/2004 Post-Dose 2 84 100
B/Jiangsu/310/2003 Post-Dose 2 28 47
2.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.
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
Geometric Mean Titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.
Arm/Group Title Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group
Hide Arm/Group Description:
Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Overall Number of Participants Analyzed 51 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/New Caledonia/20/99 Post-Dose 1
30.5
(22.3 to 41.8)
18.9
(14.1 to 25.4)
A/New York/55/2004 Post-Dose 1
21.4
(15.7 to 29.3)
65.6
(47.7 to 90.2)
B/Jiangsu/310/2003 Post-Dose 1
13.2
(9.89 to 17.6)
6.2
(5.27 to 7.29)
A/New Caledonia/20/99 Post-Dose 2
38.1
(29.6 to 49.2)
104
(77.1 to 139)
A/New York/55/2004 Post-Dose 2
78.9
(61.3 to 102)
277
(223 to 346)
B/Jiangsu/310/2003 Post-Dose 2
20.7
(16.1 to 26.6)
23.9
(18.2 to 31.3)
3.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.
Hide Description

Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA).

Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method.

The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay.

Time Frame Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs to the Pertussis, Tetanus, Diphtheria and Haemophilus Influenzae antigens were assessed in the per-protocol immunogenicity population.
Arm/Group Title Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group
Hide Arm/Group Description:
Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Overall Number of Participants Analyzed 94 104
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Pertussis Toxoid (EU/mL)
57.9
(47.9 to 69.9)
69.5
(57.6 to 83.7)
Filamentous Hemagglutinin (EU/mL)
37.3
(29.5 to 47.1)
47.3
(37.9 to 59.0)
Pertactin (EU/mL)
22.0
(16.8 to 28.8)
33.6
(26.1 to 43.2)
Fimbriae Types 2 and 3 (EU/mL)
26.7
(18.1 to 39.5)
11.6
(7.76 to 17.4)
Diphtheria (IU/mL)
0.230
(0.180 to 0.294)
0.251
(0.191 to 0.329)
Tetanus (IU/mL)
0.976
(0.694 to 1.37)
0.980
(0.720 to 1.33)
4.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.
Hide Description Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal antibodies were determined in the per-protocol population.
Arm/Group Title Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group
Hide Arm/Group Description:
Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Overall Number of Participants Analyzed 91 97
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Polyribosylribitol Phosphate (mcg/mL)
1.69
(1.16 to 2.46)
2.12
(1.49 to 3.02)
Pneumococcal 4 (mcg/mL)
1.02
(0.854 to 1.22)
0.956
(0.781 to 1.17)
Pneumococcal 6B (mcg/mL)
1.14
(0.906 to 1.44)
1.24
(0.949 to 1.61)
Pneumococcal 9V (mcg/mL)
0.974
(0.812 to 1.17)
1.20
(0.981 to 1.46)
Pneumococcal 14 (mcg/mL)
4.98
(4.12 to 6.03)
5.54
(4.56 to 6.74)
Pneumococcal 18C (mcg/mL)
0.783
(0.646 to 0.950)
0.790
(0.644 to 0.970)
Pneumococcal 19F (mcg/mL)
1.49
(1.27 to 1.74)
1.26
(1.05 to 1.51)
Pneumococcal 23F (mcg/mL)
0.920
(0.737 to 1.15)
1.00
(0.779 to 1.29)
5.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.
Hide Description Antibodies to polio viruses were measured by a serum neutralization assay.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers (GMTs) for the Polio antibodies were determined in the per-protocol population.
Arm/Group Title Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group
Hide Arm/Group Description:
Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Overall Number of Participants Analyzed 94 104
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Polio Type 1 (1/dil)
555
(415 to 742)
1072
(814 to 1411)
Polio Type 2 (1/dil)
356
(268 to 474)
550
(411 to 736)
Polio Type 3 (1/dil)
394
(282 to 551)
571
(397 to 822)
6.Other Pre-specified Outcome
Title Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Hide Description Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
Time Frame Days 0 up to 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population
Arm/Group Title Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group
Hide Arm/Group Description:
Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Overall Number of Participants Analyzed 112 130
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Injection Site Reaction Post-Dose 1 45 42
Any Tenderness 40 40
Grd 3 Tenderness (injected limb movement reduced) 1 1
Any Redness (> 0.5 cm) 11 14
Grade 3 Redness (≥ 5.0 cm) 2 1
Any Swelling (> 0.5 cm) 9 7
Grade 3 Swelling (≥ 5.0 cm) 1 0
Any Solicited Injection Site Reaction Post-Dose 2 36 34
Any Tenderness 34 28
Grd 3 Tenderness (injected limb movement reduced) 1 0
Any Redness (> 0.5 cm) 12 10
Grade 3 Redness ≥ 5.0 cm) 0 0
Any Swelling (> 0.5 cm) 10 5
Grade 3 Swelling (≥ 5.0 cm) 1 0
Any Solicited Injection Site Reaction - Any Dose 51 51
Any Tenderness 48 45
Grd 3 Tenderness (injected limb movement reduced) 2 1
Any Redness (> 0.5 cm) 16 19
Grade 3 Redness (≥ 5.0 cm) 2 1
Any Swelling (> 0.5 cm) 13 10
Grade 3 Swelling (≥ 5.0 cm) 1 0
Any Solicited Systemic Reaction Post-Dose 1 79 82
Any Fever 25 25
Grade 3 Fever ≥ 103.3 ºF) 0 1
Any Vomiting 14 7
Grade 3 Vomiting (≥ 6 episodes per 24 hours) 1 0
Any Abnormal Crying 46 32
Grade 3 Abnormal Crying (> 3 hours) 5 1
Any Drowsiness 47 45
Grade 3 Drowsiness (difficulty waking up) 1 1
Any Loss of Appetite 39 33
Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds) 1 0
Any Irritability 65 63
Grade 3 Irritability (inconsolable) 2 1
Any Solicited Systemic Reaction Post-Dose 2 64 62
Any Fever 14 14
Grade 3 Fever (≥ 103.3 ºF) 1 2
Any Vomiting 8 12
Grade 3 Vomiting (≥ 6 episodes per 24 hours) 0 3
Any Abnormal Crying 39 26
Grade 3 Abnormal Crying (> 3 hours) 2 3
Any Drowsiness 29 34
Grade 3 Drowsiness (difficulty waking up) 0 1
Any Loss of Appetite 29 28
Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds) 0 1
Any Irritability 56 43
Grade 3 Irritability (inconsolable) 3 3
Any Solicited Systemic Reaction - Any Dose 86 90
Any Fever 32 34
Grade 3 Fever (≥ 103.3 ºF) 1 2
Any Vomiting 20 16
Grade 3 Vomiting (≥ 6 episodes per 24 hours) 1 2
Any Abnormal Crying 55 45
Grade 3 Abnormal Crying (> 3 hours) 6 3
Any Drowsiness 53 53
Grade 3 Drowsiness (difficulty waking up) 1 2
Any Loss of Appetite 52 43
Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds) 1 1
Any Irritability 76 71
Grade 3 Irritability (inconsolable) 4 2
Time Frame Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group
Hide Arm/Group Description Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
All-Cause Mortality
Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/112 (4.46%)      1/130 (0.77%)    
Congenital, familial and genetic disorders     
Sickle cell anaemia with crisis * 1  0/112 (0.00%)  0 1/130 (0.77%)  3
Ear and labyrinth disorders     
Deafness bilateral * 1  1/112 (0.89%)  1 0/130 (0.00%)  0
Infections and infestations     
Bronchiolitis * 1  1/112 (0.89%)  1 0/130 (0.00%)  0
Gastroenteritis * 1  0/112 (0.00%)  0 1/130 (0.77%)  1
Gastroenteritis viral * 1  1/112 (0.89%)  1 0/130 (0.00%)  0
Pneumonia * 1  1/112 (0.89%)  1 1/130 (0.77%)  1
Pneumonia respiratory syncytial viral * 1  1/112 (0.89%)  1 0/130 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/112 (0.89%)  1 0/130 (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%
Fluzone® Vaccine-Primed Group Influenza Vaccine-Naive Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   57/112 (50.89%)      56/130 (43.08%)    
Eye disorders     
Conjunctivitis * 1  5/112 (4.46%)  5 7/130 (5.38%)  9
General disorders     
Pyrexia * 1  8/112 (7.14%)  8 6/130 (4.62%)  6
Infections and infestations     
Bronchiolitis * 1  5/112 (4.46%)  5 8/130 (6.15%)  8
Croup infectious * 1  7/112 (6.25%)  7 2/130 (1.54%)  2
Otitis media * 1  30/112 (26.79%)  34 30/130 (23.08%)  31
Upper respiratory tract infection * 1  20/112 (17.86%)  21 24/130 (18.46%)  26
Respiratory, thoracic and mediastinal disorders     
Cough * 1  7/112 (6.25%)  7 12/130 (9.23%)  13
Rhinorrhoea * 1  3/112 (2.68%)  3 8/130 (6.15%)  8
*
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: NCT00885105     History of Changes
Other Study ID Numbers: GRC32
First Submitted: April 20, 2009
First Posted: April 21, 2009
Results First Submitted: September 2, 2009
Results First Posted: January 1, 2010
Last Update Posted: April 14, 2016