NCT01240746

Study of Quadrivalent Influenza Vaccine Among Children

Safety and Immunogenicity Among Children Administered Quadrivalent Influenza Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,363 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 8 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1), and the investigational TIV containing the alternate B (B2) strain in children. Primary Objective: To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among children aged 6 months to less than 9 years of age Secondary Objective: To demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that does not contain the corresponding B strain, as assessed by GMT ratios and seroconversion rates. Observational Objective: To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.

Detailed description

Participants will receive a single dose of their assigned vaccine during Visit 1. For those requiring two doses of influenza vaccine, as per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of the assigned vaccine will be administered at Visit 2. All participants will be followed up for safety (up to 6 months post final vaccination) and for immunogenicity up to Day 28 post-vaccination (Visit 2 or Visit 3, as appropriate).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative	0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular
BIOLOGICAL	Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative	0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular
BIOLOGICAL	Quadrivalent Influenza Vaccine, No Preservative	0.25 mL (6 to 35 months), or 0.5 mL(3 to \<9 years), Intramuscular

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2010-11-15
• Last updated: 2015-07-14
• Results posted: 2014-01-14

Locations

67 sites across 1 country: United States