Immunogenicity and Safety of the Trivalent Influenza Vaccine (Split-Virion, Inactivated), Northern Hemisphere 2013-2014 Formulation (Intradermal Route)
- Conditions
- Prophylaxis of influenza (2013-2014 Northern Hemisphere Season)MedDRA version: 16.1Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-005243-25-FR
- Lead Sponsor
- Sanofi Pasteur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Aged over 18 years on the day of inclusion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65
Exclusion Criteria
- Subject is pregnant, or lactating, or of childbearing potential
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or
planned receipt of any vaccine in the 3 weeks following trial vaccination
- Vaccination against flu in the previous 12 months if administered in the
context of a clinical trial, or in the previous 6 months if administered in
the context of a flu vaccination campaign
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method