Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
- To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine [ Time Frame: 21 Days pot-vaccination ] [ Designated as safety issue: No ]
- To provide information concerning the safety of an inactivated, split-virion influenza vaccine. [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Experimental: 1
Lot 1
|
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 1
|
|
Experimental: 2
Lot 2
|
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 2
|
|
Experimental: 3
Lot 3
|
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 3
|
|
Active Comparator: 4
Control
|
Biological: Inactivated Split-virion influenza vaccine
Control Vaccine
Other Name: Vaxigrip
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
- Aged 18 to 60 years on the day of inclusion.
- Informed consent form signed.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For a woman, inability to bear a child or negative urine pregnancy test at the first visit.
Exclusion Criteria :
- Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Febrile illness (oral temperature >= 37.5°C, or rectal equivalent temperature >= 38.0°C) on the day of inclusion.
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion) at a stage that could interfere with trial conduct or completion.
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Blood or blood-derived products received in the past 3 months.
- Any vaccination in the 4 weeks preceding the trial vaccination.
- Vaccination planned in the 4 weeks following the trial vaccination.
- Previous vaccination against influenza (in the previous 6 months).
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Contacts and Locations| France | |
| Angers, France, 49000 | |
| Lithuania | |
| Vilnius, Lithuania, 08117 | |
| Spain | |
| Madrid, Spain, 28041 | |
| United Kingdom | |
| Bath, United Kingdom | |
| Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
More Information
Additional Information:
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical Monitor, Sanofi Pasteur, Inc. |
| ClinicalTrials.gov Identifier: | NCT00383539 History of Changes |
| Other Study ID Numbers: | GID23 |
| Study First Received: | September 29, 2006 |
| Last Updated: | September 24, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Lithuania: State Medicine Control Agency - Ministry of Health Spain: Ministry of Health and Consumption United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Sanofi:
|
Influenza Orthomyxoviruses Inactivated Split-virion influenza vaccine Adults |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013