Immunogenicity and Lot-to-Lot Consistency Study of a Quadrivalent Influenza Vaccine in Adult and Elderly Subjects

• Conditions: Prevention of influenza infection in adults from 18 years of age; MedDRA version: 17.1Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-000785-21-BE
• Lead Sponsor: Sanofi Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-10
• Last Update Posted: 25 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2224

Inclusion Criteria

Individuals aged over 18 years old 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 1112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1112

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 2014 Southern Hemisphere formulation or the 2014-2015 Northern Hemisphere vaccine with either the trial vaccine or another vaccine in the previous 6 months
• Subject is pregnant, or lactating, or of childbearing potential

Study & Design

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