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Trial record 1 of 1 for:    GRC35
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Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine

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ClinicalTrials.gov Identifier: NCT00389532
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : March 30, 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 (2006-2007 Fluzone® vaccine)
Enrollment 116
Recruitment Details Study participants were enrolled from October through December 2006 in 1 medical clinic in the US
Pre-assignment Details A total of 116 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Aged 18 to 59 Years Aged ≥ 60 Years
Hide Arm/Group Description Participants aged 18 to 59 years at enrollment Participants aged 60 years and older at enrollment
Period Title: Overall Study
Started 60 56
Completed 60 [1] 56
Not Completed 0 0
[1]
3 of the participants did not have valid post-vaccination serological results
Arm/Group Title Aged 18 to 59 Years Aged ≥ 60 Years Total
Hide Arm/Group Description Participants aged 18 to 59 years at enrollment Participants aged 60 years and older at enrollment Total of all reporting groups
Overall Number of Baseline Participants 60 56 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 56 participants 116 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
 100.0%
9
  16.1%
69
  59.5%
>=65 years
0
   0.0%
47
  83.9%
47
  40.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 56 participants 116 participants
39.5  (12.25) 76.4  (8.55) 57.3  (21.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 56 participants 116 participants
Female
49
  81.7%
37
  66.1%
86
  74.1%
Male
11
  18.3%
19
  33.9%
30
  25.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 56 participants 116 participants
60 56 116
1.Primary Outcome
Title Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Hide Description Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)
Time Frame 0-3 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was on all enrolled and vaccinated participants, Intend-to-treat population.
Arm/Group Title Aged 18 to 59 Years Aged ≥ 60 Years
Hide Arm/Group Description:
Participants aged 18 to 59 years at enrollment
Participants aged 60 years and older at enrollment
Overall Number of Participants Analyzed 60 56
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Injection Site Reaction 78 38
Any Pain 78 30
Grade 3 Pain (Incapacitating) 0 0
Any Redness 7 9
Grade 3 Redness (≥ 5.0 cm) 0 4
Any Swelling 3 6
Grade 3 Swelling (≥ 5.0 cm) 0 0
Any Solicited Systemic Reaction 49 29
Any Fever 3 2
Grade 3 Fever (> 102.2°F) 0 0
Any Headache 39 11
Grade 3 Headache (Prevented daily activities) 2 0
Any Malaise 25 9
Grade 3 Malaise (Prevented daily activities) 2 0
Any Myalgia 27 21
Grade 3 Myalgia (Prevented daily activities) 2 0
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
Hide Description GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.
Time Frame 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers were evaluated in the per-protocol immunogenicity Population
Arm/Group Title Aged 18 to 59 Years Aged ≥ 60 Years
Hide Arm/Group Description:
Participants aged 18 to 59 years at enrollment
Participants aged 60 years and older at enrollment
Overall Number of Participants Analyzed 55 55
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
H1N1 FLU A/NEW CALEDONIA/20/99 - PRE
66.2
(41.6 to 105)
36.9
(28.5 to 47.7)
H1N1 FLU A/NEW CALEDONIA/20/99 - POST
214
(151 to 304)
77.0
(57.9 to 102)
H3N2 FLU A/WISCONSIN/67/2005 - PRE
67.9
(44.4 to 104)
110
(70.8 to 170)
H3N2 FLU A/WISCONSIN/67/2005 - POST
453
(334 to 613)
513
(363 to 726)
B FLU B/MALAYSIA SPLIT/2506/2004 - PRE
117
(83.5 to 165)
195
(157 to 241)
B FLU B/MALAYSIA SPLIT/2506/2004 - POST
788
(589 to 1054)
597
(477 to 748)
Time Frame Up to 28 days post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aged 18 to 59 Years Aged ≥ 60 Years
Hide Arm/Group Description Participants aged 18 to 59 years at enrollment Participants aged 60 years and older at enrollment
All-Cause Mortality
Aged 18 to 59 Years Aged ≥ 60 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aged 18 to 59 Years Aged ≥ 60 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/56 (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%
Aged 18 to 59 Years Aged ≥ 60 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/60 (25.00%)      2/56 (3.57%)    
Gastrointestinal disorders     
Diarrhoea * 1  3/60 (5.00%)  4 1/56 (1.79%)  1
Nervous system disorders     
Headache * 1  7/60 (11.67%)  9 0/56 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  3/60 (5.00%)  3 1/56 (1.79%)  1
Nasal Congestion * 1  3/60 (5.00%)  3 1/56 (1.79%)  1
Pharyngolaryngeal pain * 1  3/60 (5.00%)  3 1/56 (1.79%)  1
Rhinorrhoea * 1  4/60 (6.67%)  4 0/56 (0.00%)  0
*
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: NCT00389532     History of Changes
Other Study ID Numbers: GRC35
First Submitted: October 18, 2006
First Posted: October 19, 2006
Results First Submitted: February 24, 2009
Results First Posted: March 30, 2009
Last Update Posted: April 14, 2016