Safety and Immunogenicity of a Quadrivalent Influenza Vaccine inChild/Adolescent and Adult Subjects

Conditions: Prophylaxis of influenza in subjects from 9-17 years of age (and adults aged 18 to 60 years).
MedDRA version: 14.1Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-005101-79-Outside-EU/EEA

Lead Sponsor: Sanofi Pasteur

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 2083

Inclusion Criteria

Children/adolescents aged 9 to 17 years (or adults aged 18 to 60 years) on the day of inclusion.
Are the trial subjects under 18? yes
Number of subjects for this age range: 382
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1701
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous vaccination against influenza with the 2012 Southern Hemisphere formulation or the 2011–2012 Northern Hemisphere formulation in the previous 6 months with either the trial vaccine or another vaccine.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To describe the safety profile of QIV compared to TIV.<br>;Secondary Objective: • To demonstrate that the 3 different industrial lots of QIV induce an equivalent immune response.<br><br>• To describe the immune response by haemagglutination inhibition (HAI), influenza virus seroneutralization (SN) method and anti-neuraminidase (anti-NA) immune response per vaccine group.;Primary end point(s): Occurrence of:<br>• Unsolicited systemic adverse event (AE) reported in the 30 minutes after injection;<br>• Solicited injection site reactions and systemic reactions within 7 days following injection;<br>• Unsolicited AEs within 21 days following injection;<br>• Serious adverse events (SAEs), including adverse events of special interest (AESIs), throughout the trial.;Timepoint(s) of evaluation of this end point: Up to the end of the trial for follow up of SAEs (6 months).<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Immunogenicity will be evaluated using the HAI technique in all subjects and expressed as anti-hemagglutinin (HA) individual titer on D0 and D21.<br><br>Neutralizing antiboby (Ab) titers and anti-NA titers will be measured for each influenza strain with the SN method and with ELLA method, respectively, on D0 and D21.;Timepoint(s) of evaluation of this end point: D21 after vaccination<br>