Safety and Immunogenicity of the Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Children Aged 3 to 8 Years

Conditions: Prophylaxis of influenza in children aged 3 to 8 years
MedDRA version: 14.1Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-005374-33-FI

Lead Sponsor: Sanofi Pasteur

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1225

Inclusion Criteria

Children aged 3 to less than 9 years on the day of inclusion.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1225
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
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 current seasonal vaccine formulation (as recommended by WHO), 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 demonstrate non-inferiority of antibody (Ab) responses induced by QIV compared with the TIV.;Secondary Objective: • To demonstrate the superiority of the HAI antibody response to each B strain in QIV compared with the TIV that does not contain the corresponding B strain.<br>• To describe the safety profile of QIV compared with the TIV.<br>• To describe the immune response by HAI method, influenza virus SN method and the anti-NA immune response per vaccine group.;Primary end point(s): For non-inferiority testing: GMs of anti-HA Ab titers for the four strains, as applicable, 28 days after the last vaccination.;Timepoint(s) of evaluation of this end point: 28 days after the last vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): For superiority testing: GMs of anti-HA Ab titers, as applicable, 28 days after the last vaccination.<br>Safety description: Occurrence of:<br>- unsolicited AE reported in the 30 minutes after each/any injection<br>- solicited injection site reactions and systemic reactions within 7 days following each/any injection<br>- unsolicited AEs within 28 days following each/any injection<br>- SAEs (including AESI) throughout the trial <br>HAI titers, neutralizing Ab titers and anti-NA titers will be measured for each influenza strain on D0 and D28 or D56 according to the vaccination schedule.<br>;Timepoint(s) of evaluation of this end point: 28 days after the last vaccination up to the end of the trial for follow up of SAEs.