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Study of Quadrivalent Influenza Vaccine Among Children

NCT01240746 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4363

Last updated 2015-07-14

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01240746 on ClinicalTrials.gov