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Trial record 1 of 1 for:    GRC26
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Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

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ClinicalTrials.gov Identifier: NCT00258817
Recruitment Status : Completed
First Posted : November 28, 2005
Results First Posted : March 25, 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 30
Recruitment Details Subjects were enrolled from October to December 2005
Pre-assignment Details A total of 30 subjects that met the inclusion and exclusion criteria were enrolled and vaccinated
Arm/Group Title Influenza Vaccine-naive Group Influenza Vaccine-primed Group
Hide Arm/Group Description Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively. Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Influenza Vaccine-naive Group Influenza Vaccine-primed Group Total
Hide Arm/Group Description Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively. Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
15
 100.0%
15
 100.0%
30
 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 15 participants 15 participants 30 participants
11.92  (6.36) 26.43  (8.00) 19.18  (10.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
10
  66.7%
7
  46.7%
17
  56.7%
Male
5
  33.3%
8
  53.3%
13
  43.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination
Hide Description

GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation.

Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)

Time Frame Day 14 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers were assessed on the per-protocol population.
Arm/Group Title Influenza Vaccine-naive Group Influenza Vaccine-primed Group
Hide Arm/Group Description:
Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed 13 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Flu A/New Caledonia/20/99 (H1N1) - Pre
5.0
(5.0 to 5.0)
8.2
(4.3 to 15.6)
Flu A/New Caledonia/20/99 (H1N1) - Post
187.8
(105.4 to 334.5)
95.1
(44.0 to 205.9)
Flu A/New York/55/2004 (H3N2) - Pre
8.5
(4.9 to 14.7)
32.8
(10.9 to 98.4)
Flu A/New York/55/2004 (H3N2) - Post
328.6
(181.2 to 596.0)
249.8
(88.1 to 708.6)
Flu B/Jiangsu/10/2003 - Pre
9.2
(4.6 to 18.7)
5.3
(4.7 to 5.8)
Flu B/Jiangsu/10/2003 - Post
59.7
(22.7 to 156.9)
39.0
(17.2 to 88.7)
2.Other Pre-specified Outcome
Title Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1
Hide Description Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting.
Time Frame 0 to 3 days post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis post-vaccination 1 was on all enrolled and vaccinated subjects, Intend-to-treat population.
Arm/Group Title Influenza Vaccine-naive Group Influenza Vaccine-primed Group
Hide Arm/Group Description:
Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction post-dose 1 3 2
Any injection site Tenderness 2 1
Grade 3 injection site Tenderness-reduced movement 0 0
Any injection site Erythema 1 1
Grade 3 injection site Erythema (≥ 5.0 cm) 0 1
Any injection site Swelling 1 1
Grade 3 injection site Swelling (≥ 5.0 cm) 0 0
Any Solicited Systemic Reactions post-dose 1 10 5
Any Fever (≥ 100.4°F) 1 2
Grade 3 Fever (> 103.2°F) 0 0
Any Crying abnormal 4 1
Grade 3 Crying abnormal (> 3 hours) 0 0
Any Irritability 6 1
Grade 3 Irritability (Inconsolable) 0 0
Any Vomiting (per 24 hours) 1 0
Grade 3 Vomiting (≥ 6 episodes) 0 0
Any Drowsiness 6 3
Grade 3 Drowsiness (Sleeps most time) 0 0
Any Appetite lost 4 1
Grade 3 Appetite lost (Refuse most feeds) 0 0
3.Other Pre-specified Outcome
Title Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2
Hide Description

Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting

Note: Influenza vaccine-primed group received only dose 1

Time Frame 0 to 3 days post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis post vaccination 2 was on all enrolled and vaccinated subjects, Intend-to-treat population.
Arm/Group Title Influenza Vaccine-naive Group Influenza Vaccine-primed Group
Hide Arm/Group Description:
Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed 15 0
Measure Type: Number
Unit of Measure: Participants
Any solicited injection site reaction post-dose 2 2
Any injection site Tenderness 1
Grade 3 injection site Tenderness-reduced movement 0
Any injection site Erythema 0
Grade 3 injection site Erythema (≥ 5.0 cm) 0
Any injection site Swelling 1
Grade 3 injection site Swelling (≥ 5.0 cm) 0
Any solicited systemic reactions post-dose 2 8
Any Fever (≥ 100.4 ºF) 5
Grade 3 Fever (> 103.2 ºF) 0
Any Crying abnormal 3
Grade 3 Crying abnormal (> 3 hours) 1
Any Irritability 5
Grade 3 Irritability (inconsolable) 0
Any Vomiting (per 24 hours) 0
Grade 3 Vomiting (≥ 6 episodes) 0
Any Drowsiness 2
Grade 3 Drowsiness (sleeping most time) 0
Any Appetite lost 3
Grade 3 Appetite lost (refuses most feeds) 0
Time Frame Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Influenza Vaccine-naive Group Influenza Vaccine-primed Group
Hide Arm/Group Description Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively. Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
All-Cause Mortality
Influenza Vaccine-naive Group Influenza Vaccine-primed Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Influenza Vaccine-naive Group Influenza Vaccine-primed Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Influenza Vaccine-naive Group Influenza Vaccine-primed Group
Affected / at Risk (%) Affected / at Risk (%)
Total   13/15 (86.67%)   5/15 (33.33%) 
Gastrointestinal disorders     
Vomiting NOS  1  1/15 (6.67%)  0/15 (0.00%) 
Diarrhoea * 1  1/15 (6.67%)  0/15 (0.00%) 
General disorders     
Injection site tenderness  1  3/15 (20.00%)  1/15 (6.67%) 
Injection site erythema  1  1/15 (6.67%)  1/15 (6.67%) 
Injection site swelling  1  1/15 (6.67%)  1/15 (6.67%) 
Pyrexia  1  6/15 (40.00%)  2/15 (13.33%) 
Pyrexia * 1  3/15 (20.00%)  0/15 (0.00%) 
Infections and infestations     
Otitis media * 1  1/15 (6.67%)  0/15 (0.00%) 
Upper respiratory tract infection * 1  3/15 (20.00%)  0/15 (0.00%) 
Viral infection * 1  1/15 (6.67%)  0/15 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  6/15 (40.00%)  1/15 (6.67%) 
Nervous system disorders     
Somnolence  1  6/15 (40.00%)  3/15 (20.00%) 
Psychiatric disorders     
Crying  1  5/15 (33.33%)  1/15 (6.67%) 
Irritability  1  8/15 (53.33%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
*
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: NCT00258817     History of Changes
Other Study ID Numbers: GRC26
First Submitted: November 24, 2005
First Posted: November 28, 2005
Results First Submitted: January 21, 2009
Results First Posted: March 25, 2009
Last Update Posted: April 14, 2016