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Trial record 33 of 597 for:    Fluzone® | Studies With Results

Trial to Collect Safety Data and Sera for Immunogenicity Testing

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ClinicalTrials.gov Identifier: NCT00389857
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : March 24, 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 31

Recruitment Details Subjects were recruited from 13 October to 13 December 2006, at a single site in the US.
Pre-assignment Details A total of 31 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 in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively. Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
Period Title: Overall Study
Started 14 17
Completed 14 17
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 in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively. Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 14 17 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
<=18 years
14
 100.0%
17
 100.0%
31
 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 14 participants 17 participants 31 participants
15.4  (7.40) 29.3  (6.55) 23.0  (9.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
Female
8
  57.1%
10
  58.8%
18
  58.1%
Male
6
  42.9%
7
  41.2%
13
  41.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 17 participants 31 participants
14 17 31
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination
Hide Description

GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation.

Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)

Time Frame 14 days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were evaluated in the per-protocol population.
Arm/Group Title Influenza Vaccine-Naive Group Influenza Vaccine-Primed Group
Hide Arm/Group Description:
Subjects have never received Influenza virus vaccine
Subjects have received Influenza virus vaccine in the past
Overall Number of Participants Analyzed 13 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
H1N1 Flu A/New Caledonia/20/99 - Pre
5.36
(4.83 to 5.95)
15.1
(6.51 to 34.8)
H1N1 Flu A/New Caledonia/20/99 - Post
169
(77.5 to 367)
135
(61.9 to 293)
H3N2 Flu A/Wisconsin/67/2005 - Pre
13.7
(2.97 to 62.8)
22.0
(8.27 to 58.4)
H3N2 Flu A/Wisconsin/67/2005 - Post
806
(316 to 2056)
698
(400 to 1218)
Flu B/Malaysia Split/2506/2004 - Pre
5.55
(4.92 to 6.25)
6.23
(4.71 to 8.25)
Flu B/Malaysia Split/2506/2004 - Post
234
(107 to 511)
54.8
(20.9 to 144)
2.Other Pre-specified Outcome
Title Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1.
Hide Description Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).
Time Frame 0 to 3 days post-vaccination 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population
Arm/Group Title Influenza Vaccine-Naive Group Influenza Vaccine-Primed Group
Hide Arm/Group Description:
Subjects have never received Influenza virus vaccine
Subjects have received Influenza virus vaccine in the past
Overall Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction Post-dose 1 3 6
Any injection site Tenderness 3 2
Grade 3 injection site Tenderness-reduced movement 0 0
Any injection site Pain 0 4
Grade 3 injection site Pain (Incapacitating) 0 0
Any injection site Redness 2 1
Grade 3 injection site Redness (≥ 5.0 cm) 0 0
Any injection site Swelling 1 0
Grade 3 injection site Swelling (≥ 5.0 cm) 0 0
Any Solicited Systemic Reaction Post-dose 1 7 7
Any Fever 0 1
Grade 3 Fever (>103.1°F) 0 0
Any Vomiting (Per 24 hours) 2 0
Grade 3 Vomiting (≥ 6 episodes) 0 0
Any Abnormal Crying 3 2
Grade 3 Abnormal Crying (> 3 hours) 0 0
Any Drowsiness 1 1
Grade 3 Drowsiness (Sleeping most time) 0 0
Any Loss of Appetite 1 2
Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) 0 0
Any Irritability 5 2
Grade 3 Irritability (Inconsolable) 0 0
Any Headache 0 3
Grade 3 Headache (Prevented daily activities) 0 0
Any Myalgia 1 1
Grade 3 Myalgia (Prevented daily activities) 0 0
Any Malaise 2 3
Grade 3 Malaise (Prevented daily activities) 0 0
3.Other Pre-specified Outcome
Title Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2.
Hide Description

Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).

Note: Influenza vaccine-primed group did not receive vaccination 2

Time Frame 0 to 3 days post-vaccination 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Safety analysis was on all enrolled and vaccinated participants, intend to treat population.

Influenza vaccine-primed group did not received vaccination 2

Arm/Group Title Influenza Vaccine-Naive Group Influenza Vaccine-Primed Group
Hide Arm/Group Description:
Subjects have never received Influenza virus vaccine
Subjects have received Influenza virus vaccine in the past
Overall Number of Participants Analyzed 14 0
Measure Type: Number
Unit of Measure: Participants
Any solicited injection site reaction Post-dose 2 4
Any injection site Tenderness 4
Grade 3 injection site Tenderness-reduced movement 0
Any injection site Pain 0
Grade 3 injection site Pain (incapacitating) 0
Any injection site Redness 3
Grade 3 injection site Redness (≥ 5.0 cm) 0
Any injection site Swelling 1
Grade 3 injection site Swelling (≥ 5.0 cm) 0
Any solicited systemic reaction Post-dose 2 6
Any Fever 1
Grade 3 Fever (> 103.1ºF) 0
Any Vomiting (per 24 hours) 2
Grade 3 Vomiting (≥ 6 episodes) 0
Any abnormal Crying 4
Grade 3 abnormal Crying (> 3 hours) 0
Any Drowsiness 3
Grade 3 Drowsiness (sleeping most time) 0
Any Loss of appetite 5
Grade 3 Loss of appetitie (refuses 3 feeds) 0
Any Irritability 5
Grade 3 Irritability (inconsolable) 0
Any Headache 0
Grade 3 Headache (prevents daily activities) 0
Any Myalgia 0
Grade 3 Myalgia (prevents daily activities) 0
Any Malaise 0
Grade 3 Malaise (prevents daily activities) 0
Time Frame Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (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 in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively. Participants have received Influenza virus vaccine in the past. They received a single dose 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   0/14 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Influenza Vaccine-Naive Group Influenza Vaccine-Primed Group
Affected / at Risk (%) Affected / at Risk (%)
Total   9/14 (64.29%)   7/17 (41.18%) 
Gastrointestinal disorders     
Vomiting NOS  1  2/14 (14.29%)  0/17 (0.00%) 
Diarrhoea * 1  1/14 (7.14%)  1/17 (5.88%) 
Haematochezia * 1  0/14 (0.00%)  1/17 (5.88%) 
Teething * 1  1/14 (7.14%)  1/17 (5.88%) 
Vomiting * 1  1/14 (7.14%)  0/17 (0.00%) 
General disorders     
Injection site tenderness  1  4/14 (28.57%)  2/17 (11.76%) 
Injection site pain  1  0/14 (0.00%)  4/17 (23.53%) 
Injection site redness  1  3/14 (21.43%)  1/17 (5.88%) 
Injection site swelling  1  1/14 (7.14%)  0/17 (0.00%) 
Pyrexia  1  1/14 (7.14%)  1/17 (5.88%) 
Malaise  1  2/14 (14.29%)  3/17 (17.65%) 
Irritability * 1  1/14 (7.14%)  1/17 (5.88%) 
Pyrexia * 1  1/14 (7.14%)  1/17 (5.88%) 
Infections and infestations     
Nasopharyngitis * 1  0/14 (0.00%)  1/17 (5.88%) 
Otitis media * 1  1/14 (7.14%)  0/17 (0.00%) 
Upper respiratory tract infection * 1  2/14 (14.29%)  0/17 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  5/14 (35.71%)  2/17 (11.76%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  1/14 (7.14%)  1/17 (5.88%) 
Nervous system disorders     
Somnolence  1  3/14 (21.43%)  1/17 (5.88%) 
Headache  1  0/14 (0.00%)  3/17 (17.65%) 
Psychiatric disorders     
Crying  1  4/14 (28.57%)  2/17 (11.76%) 
Irritability  1  6/14 (42.86%)  2/17 (11.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/14 (0.00%)  1/17 (5.88%) 
Nasal congestion * 1  0/14 (0.00%)  1/17 (5.88%) 
Rhinorrhoea * 1  0/14 (0.00%)  1/17 (5.88%) 
Indicates events were collected by systematic assessment
*
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
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00389857     History of Changes
Other Study ID Numbers: GRC34
First Submitted: October 18, 2006
First Posted: October 19, 2006
Results First Submitted: February 24, 2009
Results First Posted: March 24, 2009
Last Update Posted: April 14, 2016