MedTrace Logo

Study of Quadrivalent Influenza Vaccine Among Adults

NCT01218646 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 739

Last updated 2013-10-23

Study results available
· View outcomes & findings →

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, and the investigational TIV containing the alternate B strain in adult subjects.

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 subjects 65 years of age and older

Observational Objective:

* To describe the safety profiles of TIV among subjects 18 years of age and older and QIV in subjects 65 years and older, 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

Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative

0.5 mL, Intramuscular

BIOLOGICAL

Investigational Trivalent Inactivated Influenza Vaccine, No Preservative

0.5 mL, Intramuscular

BIOLOGICAL

Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative

0.5 mL, Intramuscular

BIOLOGICAL

Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative

0.5 mL, 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
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-03-31
Completion
2011-04-30

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 NCT01218646 on ClinicalTrials.gov