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Trial record 1 of 1 for:    GCE03
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Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT00845429
Recruitment Status : Completed
First Posted : February 18, 2009
Results First Posted : December 17, 2012
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Influenza
Orthomyxoviruses
Myxovirus Infection
Interventions Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)
Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)
Biological: Influenza virus vaccine (2007-2008 Formulation)
Enrollment 729
Recruitment Details Participants were enrolled from 16 to 23 October 2007 in 15 clinical centers in the US.
Pre-assignment Details A total of 729 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Arm/Group Title Group 1: Standard Dose Cell-Based Influenza Vaccine Group 2: High-dose Cell-Based Influenza Vaccine Group 3: Licensed Fluzone® Influenza Vaccine
Hide Arm/Group Description Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly. Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly. Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Period Title: Overall Study
Started 244 241 244
Completed 230 226 224
Not Completed 14 15 20
Reason Not Completed
Protocol Violation             5             4             7
Lost to Follow-up             7             9             10
Withdrawal by Subject             2             2             2
Serious adverse event             0             0             1
Arm/Group Title Group 1: Standard Dose Cell-Based Influenza Vaccine Group 2: High-dose Cell-Based Influenza Vaccine Group 3: Licensed Fluzone® Influenza Vaccine Total
Hide Arm/Group Description Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly. Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly. Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly. Total of all reporting groups
Overall Number of Baseline Participants 244 241 244 729
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 241 participants 244 participants 729 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
244
 100.0%
241
 100.0%
244
 100.0%
729
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 244 participants 241 participants 244 participants 729 participants
34.4  (9.41) 34.5  (9.18) 34.1  (9.42) 34.3  (9.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 241 participants 244 participants 729 participants
Female
158
  64.8%
162
  67.2%
151
  61.9%
471
  64.6%
Male
86
  35.2%
79
  32.8%
93
  38.1%
258
  35.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 244 participants 241 participants 244 participants 729 participants
244 241 244 729
1.Primary Outcome
Title Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.
Hide Description [Not Specified]
Time Frame Days 0 and 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the full analysis set population.
Arm/Group Title Group 1: Standard Dose Cell-Based Influenza Vaccine Group 2: High-dose Cell-Based Influenza Vaccine Group 3: Licensed Fluzone® Influenza Vaccine
Hide Arm/Group Description:
Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Overall Number of Participants Analyzed 236 233 238
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1: Solomon Islands, Day 0 (N = 236, 231, 237)
25.9
(21.0 to 32.0)
26.4
(21.6 to 32.4)
26.6
(21.7 to 32.5)
A/H1N1: Solomon Islands, Day 21 (N= 236, 232, 238)
184.8
(150.1 to 227.5)
226.6
(187.2 to 274.4)
425.1
(357.2 to 505.9)
A/H3N2: Wisconsin, Day 0 (N = 236, 232, 237)
51.2
(41.2 to 63.6)
53.4
(43.8 to 65.2)
51.5
(41.4 to 64.0)
A/H3N2: Wisconsin, Day 21 (N = 236, 230, 238)
288.3
(243.1 to 342.0)
351.3
(302.2 to 408.5)
692.4
(596.3 to 803.9)
B: Malaysia, Day 0 (N = 236, 233, 238)
13.4
(11.8 to 15.1)
14.3
(12.6 to 16.3)
14.2
(12.5 to 16.2)
B: Malaysia, Day 21 (nN= 235, 233, 237)
51.1
(43.2 to 60.4)
53.0
(45.6 to 61.6)
108.6
(95.4 to 123.7)
2.Primary Outcome
Title Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.
Hide Description Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in the full analysis set population.
Arm/Group Title Group 1: Standard Dose Cell-Based Influenza Vaccine Group 2: High-dose Cell-Based Influenza Vaccine Group 3: Licensed Fluzone® Influenza Vaccine
Hide Arm/Group Description:
Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Overall Number of Participants Analyzed 236 233 238
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1: Solomon Islands Day 0 (N = 236, 231, 237) 40 39 41
A/H1N1: Solomon Islands Day 21 (N = 236, 232, 238) 86 90 98
A/H3N2: Wisconsin Day 0 (N = 236, 232, 237) 54 62 55
A/H3N2: Wisconsin Day 21 (N = 236, 230, 238) 94 98 99
B: Malaysia Day 0 (N = 236, 233, 238) 14 20 20
B: Malaysia Day 21 (N = 235, 233, 237) 60 64 87
3.Primary Outcome
Title Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.
Hide Description

Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21.

Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.

Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion and significant increase in Influenza vaccine antibodies were assessed in the full analysis set population.
Arm/Group Title Group 1: Standard Dose Cell-Based Influenza Vaccine Group 2: High-dose Cell-Based Influenza Vaccine Group 3: Licensed Fluzone® Influenza Vaccine
Hide Arm/Group Description:
Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Overall Number of Participants Analyzed 236 233 238
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1: Solomon Islands (N = 236, 231, 237) 54 63 74
A/H3N2: Wisconsin (N = 236, 230, 237) 50 53 71
B: Malaysia (N = 235, 233, 237) 38 38 61
4.Secondary Outcome
Title Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.
Hide Description

Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.

Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.

Time Frame Day 0 up to Day 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 Group 1: Standard Dose Cell-Based Influenza Vaccine Group 2: High-dose Cell-Based Influenza Vaccine Group 3: Licensed Fluzone® Influenza Vaccine
Hide Arm/Group Description:
Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
Overall Number of Participants Analyzed 244 241 244
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 117 156 184
Any Pain 103 144 175
Grade 3 Pain (incapacitating, prevents activities) 1 2 1
Any Erythema 36 57 55
Grade 3 Erythema (≥ 5 cm) 0 0 4
Any Swelling 24 23 36
Grade 3 Swelling (≥ 5 cm) 0 0 1
Any Ecchymosis 6 19 14
Grade 3 Ecchymosis (≥ 5 cm) 0 0 1
Any Induration 31 29 38
Grade 3 Induration (≥ 5 cm) 0 0 0
Any Solicited Systemic Reaction 114 126 137
Any Fever 13 9 11
Grade 3 Fever (39.0 ºC or 102.2 ºF) 0 0 2
Any Headache 75 85 89
Grade 3 Headache (Prevents daily activities) 3 3 6
Any Malaise 58 54 63
Grade 3 Malaise (Prevents daily activities) 6 4 5
Any Myalgia 60 70 83
Grade 3 Myalgia (Prevents daily activities) 1 3 4
Any Rigors 16 9 13
Grade 3 Rigors (Prevents daily activities) 2 1 1
Time Frame Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: Standard Dose Cell-Based Influenza Vaccine Group 2: High-dose Cell-Based Influenza Vaccine Group 3: Licensed Fluzone® Influenza Vaccine
Hide Arm/Group Description Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly. Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly. Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
All-Cause Mortality
Group 1: Standard Dose Cell-Based Influenza Vaccine Group 2: High-dose Cell-Based Influenza Vaccine Group 3: Licensed Fluzone® Influenza Vaccine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Standard Dose Cell-Based Influenza Vaccine Group 2: High-dose Cell-Based Influenza Vaccine Group 3: Licensed Fluzone® Influenza Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/244 (1.23%)      4/241 (1.66%)      6/244 (2.46%)    
Hepatobiliary disorders       
Biliary Dyskinesia * 1  0/244 (0.00%)  0 0/241 (0.00%)  0 1/244 (0.41%)  1
Gallbladder Non-functioning * 1  0/244 (0.00%)  0 1/241 (0.41%)  1 0/244 (0.00%)  0
Infections and infestations       
Diverticulitis * 1  1/244 (0.41%)  1 0/241 (0.00%)  0 0/244 (0.00%)  0
Gastroenteritis * 1  1/244 (0.41%)  1 0/241 (0.00%)  0 1/244 (0.41%)  1
Injury, poisoning and procedural complications       
Gastrointestinal Stoma Complication * 1  0/244 (0.00%)  0 1/241 (0.41%)  1 0/244 (0.00%)  0
Pelvic Fracture * 1  0/244 (0.00%)  0 0/241 (0.00%)  0 1/244 (0.41%)  1
Tibia Fracture * 1  0/244 (0.00%)  0 1/241 (0.41%)  1 0/244 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration * 1  1/244 (0.41%)  1 0/241 (0.00%)  0 0/244 (0.00%)  0
Diabetic Ketoacidosis * 1  0/244 (0.00%)  0 0/241 (0.00%)  0 1/244 (0.41%)  1
Musculoskeletal and connective tissue disorders       
Intervertebral Disc Protrusion * 1  0/244 (0.00%)  0 0/241 (0.00%)  0 1/244 (0.41%)  1
Nervous system disorders       
Loss of Consciousness * 1  0/244 (0.00%)  0 0/241 (0.00%)  0 1/244 (0.41%)  1
Pregnancy, puerperium and perinatal conditions       
Abortion Spontaneous * 1  0/244 (0.00%)  0 1/241 (0.41%)  1 0/244 (0.00%)  0
Psychiatric disorders       
Depression * 1  1/244 (0.41%)  1 0/241 (0.00%)  0 0/244 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis * 1  0/244 (0.00%)  0 1/241 (0.41%)  1 0/244 (0.00%)  0
Reproductive system and breast disorders       
Ovarian Cyst Ruptured * 1  0/244 (0.00%)  0 0/241 (0.00%)  0 1/244 (0.41%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MeDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: Standard Dose Cell-Based Influenza Vaccine Group 2: High-dose Cell-Based Influenza Vaccine Group 3: Licensed Fluzone® Influenza Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   158/244 (64.75%)      179/241 (74.27%)      199/244 (81.56%)    
General disorders       
Injection site Pain  1  103/240 (42.92%)  144/234 (61.54%)  175/238 (73.53%) 
Injection site Erythema  2  36/240 (15.00%)  57/234 (24.36%)  55/238 (23.11%) 
Injection site Swelling  2  24/240 (10.00%)  23/234 (9.83%)  36/238 (15.13%) 
Injection site Ecchymosis  2  6/240 (2.50%)  19/234 (8.12%)  14/238 (5.88%) 
Injection site Induration  2  31/240 (12.92%)  29/234 (12.39%)  38/238 (15.97%) 
Fever  2  13/240 (5.42%)  9/234 (3.85%)  11/238 (4.62%) 
Malaise  2  58/240 (24.17%)  54/234 (23.08%)  63/238 (26.47%) 
Rigors  2  16/240 (6.67%)  9/234 (3.85%)  13/238 (5.46%) 
Musculoskeletal and connective tissue disorders       
Myalgia  2  60/240 (25.00%)  70/234 (29.91%)  83/238 (34.87%) 
Nervous system disorders       
Headache * 2  75/240 (31.25%)  85/234 (36.32%)  89/238 (37.39%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MeDRA
2
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
ClinicalTrials.gov Identifier: NCT00845429     History of Changes
Other Study ID Numbers: GCE03
First Submitted: February 13, 2009
First Posted: February 18, 2009
Results First Submitted: November 17, 2012
Results First Posted: December 17, 2012
Last Update Posted: December 19, 2012