Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00383539 |
The primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of the manufacturing process.
Secondary Objectives:
Immunogenicity
To demonstrate that the investigational vaccine induces an immune response at least as good as the one induced by the reference vaccine, in terms of antibody titers. To assess the immunogenicity of the investigational vaccine using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96).
Safety:
To demonstrate that the investigational vaccine is at least as well tolerated as the reference vaccine, in terms of defined safety profile.
To describe the safety profile after vaccination.
Comfort of the vaccination assessment:
To assess the pain immediately after the injection using a Verbal Rating Scale. To describe the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire.
Condition | Intervention | Phase |
---|---|---|
Orthomyxoviridae Infection Influenza Myxovirus Infection |
Biological: Inactivated Split-virion influenza vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 2256 |
Study Start Date: | September 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Lot 1
|
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 1
|
2: Experimental
Lot 2
|
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 2
|
3: Experimental
Lot 3
|
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 3
|
4: Active Comparator
Control
|
Biological: Inactivated Split-virion influenza vaccine
Control Vaccine
|
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
France | |
ANGERS, France, 49000 | |
Lithuania | |
Vilnius, Lithuania, 08117 | |
Spain | |
Madrid, Spain, 28041 | |
United Kingdom | |
Bath, United Kingdom |
Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur, Inc. ( Medical Monitor ) |
Study ID Numbers: | GID23 |
Study First Received: | September 29, 2006 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00383539 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Lithuania: State Medicine Control Agency - Ministry of Health; Spain: Ministry of Health and Consumption; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Influenza Orthomyxoviruses Inactivated Split-virion influenza vaccine Adults |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Virus Diseases Communicable Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections Infection |