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Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®

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ClinicalTrials.gov Identifier: NCT00755274
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : April 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
Conditions Influenza
Orthomyxoviridae Infections
Intervention Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose
Enrollment 32
Recruitment Details Participants were enrolled from 15 September to 1 October 2008 in 1 clinical center in the US.
Pre-assignment Details A total of 32 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Primed Group Naive/Inadequately Primed Group
Hide Arm/Group Description Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Period Title: Overall Study
Started 24 8
Completed 24 8
Not Completed 0 0
Arm/Group Title Primed Group Naive/Inadequately Primed Group Total
Hide Arm/Group Description Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2. Total of all reporting groups
Overall Number of Baseline Participants 24 8 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 8 participants 32 participants
<=18 years
24
 100.0%
8
 100.0%
32
 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 24 participants 8 participants 32 participants
32.8  (10.52) 22.1  (10.36) 30.1  (11.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 8 participants 32 participants
Female
13
  54.2%
4
  50.0%
17
  53.1%
Male
11
  45.8%
4
  50.0%
15
  46.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 8 participants 32 participants
24 8 32
1.Primary Outcome
Title Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Hide Description Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Time Frame Day 0 to Day 3 post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants with available post-vaccination 1 data, intent-to-treat population.
Arm/Group Title Primed Group Naive/Inadequately Primed Group
Hide Arm/Group Description:
Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Overall Number of Participants Analyzed 24 8
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 10 2
Any Tenderness 2 1
Grade 3 Tenderness (Cries When Limb Is Moved) 0 0
Any Pain 8 1
Grade 3 Pain (Incapacitating) 0 0
Any Erythema 0 2
Grade 3 Erythema (≥ 5 cm) 0 0
Any Swelling 1 1
Grade 3 Swelling (≥ 5 cm) 0 0
Any Solicited Systemic Reaction 12 4
Any Fever 2 2
Grade 3 Fever (> 103.1 ºF) 0 0
Any Vomiting 0 1
Grade 3 Vomiting (≥ 6 Episodes per 24 hours) 0 0
Any Crying Abnormal 0 0
Grade 3 Crying Abnormal (> 3 hours) 0 0
Any Drowsiness 4 0
Grade 3 Drowsiness (Sleeps most of time) 0 0
Any Appetite Lost 1 0
Grade 3 Appetite Lost (Refuses ≥ 3 meals/feeds) 0 0
Any Irritability 2 1
Grade 3 Irritability (Inconsolable) 0 0
Any Headache 1 1
Grade 3 Headache (Prevents daily activities) 0 0
Any Malaise 4 1
Grade 3 Malaise (Prevents daily activities) 0 0
Any Myalgia 6 0
Grade 3 Myalgia (Prevents daily activities) 0 0
2.Primary Outcome
Title Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Hide Description Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Time Frame Day 0 to Day 3 post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis (post-vaccination 2) was on all enrolled and vaccinated participants with available data, intent-to-treat population. (Data is part of Primary Outcome 1, no data were generated for the Primed Group)
Arm/Group Title Primed Group Naive/Inadequately Primed Group
Hide Arm/Group Description:
Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Overall Number of Participants Analyzed 0 8
Measure Type: Number
Unit of Measure: Participants
Any Solicited injection site reaction 3
Any Tenderness 1
Grade 3 Tenderness (Cries when limb is moved) 0
Any Pain 2
Grade 3 Pain (Incapacitating) 0
Any Erythema 1
Grade 3 Erythema (≥ 5cm) 0
Any Swelling 2
Grade 3 Swelling (≥ 5cm) 0
Any Solicited Systemic Reaction 4
Any Fever 2
Grade 3 Fever (> 103.1 ºF) 0
Any Vomiting 0
Grade 3 Vomiting (≥ 6 Episode per 24 hour) 0
Any Crying Abnormal 2
Grade 3 Crying Abnormal (> 3 hours) 0
Any Drowsiness 1
Grade 3 Drowsiness (Sleeps most of the time) 0
Any Appetite Lost 0
Grade 3 Appetite Lost (Refuses ≥ 3 meals/feeds) 0
Any Irritability 1
Grade 3 Irritability (Inconsolable) 0
Any Headache 0
Grade 3 Headache (Prevents daily activities) 0
Any Malaise 1
Grade 3 Malaise (Prevents daily activities) 0
Any Myalgia 1
Grade 3 Myalgia (Prevents daily activities) 0
3.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Hide Description [Not Specified]
Time Frame Day 28 post-single dose or Day 21 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description

Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population.

One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data.

Arm/Group Title Primed Group Naive/Inadequately Primed Group
Hide Arm/Group Description:
Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Overall Number of Participants Analyzed 23 7
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 Flu A/Brisbane/59/2007 IVR-148 Pre, All
54.8
(28.5 to 105.5)
8.6
(3.5 to 21.3)
H3N2 Flu A/Uruguay/716/2007/X175-C Pre, All
24.5
(12.7 to 47.6)
10.5
(3.0 to 37.1)
B Flu B/Florida/04/2006 Pre, All
5.3
(4.9 to 5.8)
5.0
(5.0 to 5.0)
H1N1 Flu A/Brisbane/59/2007 IVR-148 Pre, 6-35 mo
46.5
(21.5 to 101.0)
8.6
(3.5 to 21.3)
H3N2 Flu A/Uruguay/716/2007/X175-C Pre, 6-35 mo
17.9
(8.4 to 38.3)
10.5
(3.0 to 37.1)
B Flu B/Florida/04/2006 Pre, 6-35 mo
5.2
(4.8 to 5.7)
5.0
(5.0 to 5.0)
H1N1 Flu A/Brisbane/59/2007 IVR-148 Post, All
320.0
(218.7 to 468.3)
168.1
(70.0 to 403.9)
H3N2 Flu A/Uruguay/716/2007/X175-C Post, All
510.5
(305.2 to 854.0)
226.3
(62.8 to 815.5)
B Flu B/Florida/04/2006 Post, All
26.2
(13.1 to 52.4)
31.2
(14.0 to 69.5)
H1N1 Flu A/Brisbane/59/2007 IVR-148 Post, 6-35 mo
320.0
(196.8 to 520.4)
168.1
(70.0 to 403.9)
H3N2 Flu A/Uruguay/716/2007/X175-C Post, 6-35 mo
424.1
(223.5 to 804.7)
226.3
(62.8 to 815.5)
B Flu B/Florida/04/2006 Post, 6-35 mo
18.3
(8.2 to 40.9)
31.2
(14.0 to 69.5)
4.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Hide Description [Not Specified]
Time Frame Day 28 post-single dose or Day 21 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description

Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population. (Data is part of Outcome 3, no data were generated for the Naive/Inadequately Primed Group).

One of the enrolled participants in the Primed group did not have valid post-vaccination serology test data.

Arm/Group Title Primed Group Naive/Inadequately Primed Group
Hide Arm/Group Description:
Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Overall Number of Participants Analyzed 23 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 Flu A/Brisbane/59/2007 IVR-148, Pre 36-59 mo
84.8
(16.0 to 448.2)
H3N2 Flu A/Uruguay/716/2007/ X175-C, Pre 36-59 mo
56.6
(12.3 to 260.2)
B Flu B/Florida/04/2006, Pre 36-59 mo
5.6
(4.2 to 7.6)
H1N1 Flu A/Brisbane/59/2007 IVR-148, Post 36-59 mo
320.0
(142.8 to 716.9)
H3N2 Flu A/Uruguay/716/2007/ X175-C, Post 36-59 mo
780.2
(274.5 to 2217.2)
B Flu B/Florida/04/2006, Post 36-59 mo
59.4
(13.5 to 262.5)
5.Other Pre-specified Outcome
Title Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
Hide Description Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.
Time Frame Day 28 post-single dose or Day 21 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description

Seroprotection post-vaccination were determined in the per-protocol population.

One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data.

Arm/Group Title Primed Group Naive/Inadequately Primed Group
Hide Arm/Group Description:
Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Overall Number of Participants Analyzed 23 7
Measure Type: Number
Unit of Measure: Percentage of participants
H1N1 Flu A/Brisbane/59/2007 IVR-148 - All 100 100
H3N2 Flu A/Uruguay/716/2007/X175-C - All 100 86
B Flu B/Florida/04/2006 - All 44 71
H1N1 Flu A/Brisbane/59/2007 IVR-148 - 6-35 mo 100 100
H3N2 Flu A/Uruguay/716/2007/X175-C - 6-35 mo 100 86
B Flu B/Florida/04/2006 - 6-35 mo 31 71
6.Other Pre-specified Outcome
Title Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
Hide Description Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.
Time Frame Day 28 post-single dose or Day 21 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description

Seroprotection post-vaccination were determined in the per-protocol population. (Data is part of Outcome 5, no data were generated for the Naive/Inadequately Primed Group).

One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data.

Arm/Group Title Primed Group Naive/Inadequately Primed Group
Hide Arm/Group Description:
Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Overall Number of Participants Analyzed 23 0
Measure Type: Number
Unit of Measure: Percentage of participants
H1N1 Flu A/Brisbane/59/2007 IVR-148, 36-59 mo 100
H3N2 Flu A/Uruguay/716/2007/ X175-C, 36-59 mo 100
B Flu B/Florida/04/2006, 36-59 mo 71
7.Other Pre-specified Outcome
Title Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
Hide Description Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.
Time Frame Day 28 post-single dose or Day 21 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description

Four-fold rises in vaccine Influenza titers were determined in the per-protocol population.

One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data.

Arm/Group Title Primed Group Naive/Inadequately Primed Group
Hide Arm/Group Description:
Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Overall Number of Participants Analyzed 23 7
Measure Type: Number
Unit of Measure: Percentage of participants
H1N1 Flu A/Brisbane/59/2007 IVR-148 - All 50 86
H3N2 Flu A/Uruguay/716/2007/X175-C - All 91 86
B Flu B/Florida/04/2006 - All 41 71
H1N1 Flu A/Brisbane/59/2007 IVR-148 - 6-35 mo 50 86
H3N2 Flu A/Uruguay/716/2007/X175-C - 6-35 mo 94 86
B Flu B/Florida/04/2006 - 6-35 mo 31 71
8.Other Pre-specified Outcome
Title Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
Hide Description Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.
Time Frame Day 28 post-single dose or Day 21 post-Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description

Fold-rises in vaccine Influenza titers were determined in the per-protocol population. (Data is part of Outcome 7, no data were generated for the Naive/Inadequately Primed Group).

One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data.

Arm/Group Title Primed Group Naive/Inadequately Primed Group
Hide Arm/Group Description:
Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Overall Number of Participants Analyzed 23 0
Measure Type: Number
Unit of Measure: Percentage of participants
H1N1 Flu A/Brisbane/59/2007 IVR-148, 36-59 mo 50
H3N2 Flu A/Uruguay/716/2007/X-175-C, 36-59 mo 83
B Flu B/Florida/04/2006, 36-59 mo 67
Time Frame Adverse event data were collected through the entire study, 1 or 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Primed Group Naive/Inadequately Primed Group
Hide Arm/Group Description Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
All-Cause Mortality
Primed Group Naive/Inadequately Primed Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Primed Group Naive/Inadequately Primed Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Primed Group Naive/Inadequately Primed Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/24 (16.67%)      4/8 (50.00%)    
Gastrointestinal disorders     
Diarrhoea * 1  1/24 (4.17%)  1 1/8 (12.50%)  1
Vomiting * 1  2/24 (8.33%)  3 0/8 (0.00%)  0
Infections and infestations     
Nasopharyngitis * 1  0/24 (0.00%)  0 1/8 (12.50%)  1
Sinusitis * 1  0/24 (0.00%)  0 1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/24 (8.33%)  2 2/8 (25.00%)  3
Rhinorrhoea * 1  1/24 (4.17%)  1 1/8 (12.50%)  1
Skin and subcutaneous tissue disorders     
Rash * 1  0/24 (0.00%)  0 1/8 (12.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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: NCT00755274     History of Changes
Other Study ID Numbers: GRC40
First Submitted: September 16, 2008
First Posted: September 18, 2008
Results First Submitted: February 1, 2010
Results First Posted: April 1, 2010
Last Update Posted: April 14, 2016