CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,363 enrolled
Drug / intervention
Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative +2 morebiological
Likely dose
Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative 0.25 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01240746
NCT01240746Phase 3Completed
CompareCT.gov

Safety and Immunogenicity Among Children Administered Quadrivalent Influenza Vaccine

Sanofi Pasteur, a Sanofi Company·interventional·Posted Nov 15, 2010·Updated Jul 14, 2015

In Brief

A Phase 3 clinical trial evaluating Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative, Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative, and 1 other intervention for Influenza. Completed, enrolled 4,363 participants across 67 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 15, 2010
Enrollment StartNov 1, 2010
Primary CompletionDec 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.6 years ago

Interventions

Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservativebiological

0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular

Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservativebiological

0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular

Quadrivalent Influenza Vaccine, No Preservativebiological

0.25 mL (6 to 35 months), or 0.5 mL(3 to \<9 years), Intramuscular