Efficacy and Immunogenicity Study of Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Healthy Children Aged 6 to 35 Months

Phase 1

• Conditions: Prevention of influenza infection in children aged 6 to 35 months; MedDRA version: 16.1Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-001231-51-ES
• Lead Sponsor: Sanofi Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-04
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9000

Inclusion Criteria

Healthy children aged 6 to less than 36 months not previously vaccinated against influenza.
Are the trial subjects under 18? yes
Number of subjects for this age range: 9000
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

?At risk? children according to the definition from the Advisory Committee on Immunization Practices (ACIP).

Study & Design

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