Trial record 1 of 1 for:
GCE03
Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00845429 |
Recruitment Status :
Completed
First Posted : February 18, 2009
Results First Posted : December 17, 2012
Last Update Posted : December 19, 2012
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
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 | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 244 participants | 241 participants | 244 participants | 729 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
244 100.0%
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241 100.0%
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244 100.0%
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729 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 244 participants | 241 participants | 244 participants | 729 participants | |
Female |
158 64.8%
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162 67.2%
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151 61.9%
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471 64.6%
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Male |
86 35.2%
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79 32.8%
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93 38.1%
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258 35.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 244 participants | 241 participants | 244 participants | 729 participants |
244 | 241 | 244 | 729 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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. |
EMail: | RegistryContactUs@sanofipasteur.com |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00845429 |
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 |