Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adult and Elderly Subjects

• Conditions: Prophylaxis of influenza in subjects from 18 years of age; MedDRA version: 14.0Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-001976-21-DE
• Lead Sponsor: Sanofi Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-26
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1568

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 784
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 784

Exclusion Criteria

- Receipt of any vaccine in the 4 weeks preceding trial vaccination or planned receipt of any vaccine in the 3 weeks following trial vaccination
- Previous vaccination against influenza with the 2011-2012 Northern Hemisphere vaccine, with either the trial vaccine or another vaccine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified