EUCTR2009-017690-38-FR
Active, not recruiting
Phase 1
Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intramuscular Route) - Immunogenicity and Safety of a Vaccine against Influenza (2010-2011 NH season, intramuscular route)
Sanofi Pasteur SA0 sites129 target enrollmentMarch 12, 2010
DrugsVAXIGRIP
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Vaccination of adults up to 60 years of age an elderly of 61 years of age and over with inactivated split-virion influenza vaccine administerd by intramuscular route.
- Sponsor
- Sanofi Pasteur SA
- Enrollment
- 129
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •An individual must fulfill all of the following criteria in order to be eligible for trial
- •enrollment:
- •1\) Aged 18 years or over on the day of inclusion
- •2\) Informed consent form has been signed and dated
- •3\) Able to attend all scheduled visits and to comply with all trial procedures
- •4\) For a woman of childbearing potential, use of an effective method of
- •contraception or abstinence from at least 4 weeks prior to vaccination until at least
- •4 weeks after vaccination
- •5\) Entitled to national social security
- •Are the trial subjects under 18? no
Exclusion Criteria
- •An individual fulfilling any of the following criteria is to be excluded from trial
- •enrollment:
- •1\) Febrile illness (temperature \=38\.0°C) or moderate or severe acute illness/infection
- •(according to investigator judgment) on the day of vaccination
- •2\) Known systemic hypersensitivity to eggs, chicken proteins, neomycin,
- •formaldehyde and octoxynol\-9, or to any of the vaccine components, or history of
- •a life\-threatening reaction to the vaccine used in the trial or to a vaccine
- •containing any of the same substances
- •3\) Known pregnancy, or a positive urine pregnancy test
- •4\) Currently breastfeeding a child
Outcomes
Primary Outcomes
Not specified
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