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: 17.0Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2014-000785-21-DE

Lead Sponsor: Sanofi Pasteur

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: • Immunogenicity: Lot Consistency<br>To demonstrate equivalence of immune response induced by the 3 different industrial lots of Quadrivalent Influenza Vaccine (QIV) for each strain<br>• Immunogenicity: Non-inferiority<br>To demonstrate the non-inferiority of immune response induced by QIV compared with Trivalent Influenza Vaccine (TIV) for each strain;Secondary Objective: Immunogenicity:<br>• To confirm the superiority of immune response to each B strain in QIV compared with the TIV that does not contain the corresponding B strain.<br>• To describe the immune response of QIV <br>Safety:<br>• To describe the safety profile of QIV and TIV;Primary end point(s): Hemagglutinin (HA) antibody titers for the strains contained in the vaccine of the considered group, 21 days after vaccination. Geometric mean of titers (GMTs) will be used as the primary parameter;Timepoint(s) of evaluation of this end point: 21 days after vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Immunogenicity:<br>Immune responses in all groups for each influenza strain (HAI) on D0 and D21<br>Comparison of immune response at Day 21 between QIV and TIV (common strains and B strains not in TIV)<br>• Safety: Adverse Event (AE) and Serious Adverse Events (SAEs) throughout the study;Timepoint(s) of evaluation of this end point: • Immunogenicity: 0 and 21 days after vaccination <br>• Safety: <br>- unsolicited systemic AEs in the 30 min after injection<br>- solicited Adverse Reactions (ARs) within 7days following injection<br>- unsolicited AEs within 21days following injection<br>- EMA criteria: in the 3 days following injection<br>