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Study of a Quadrivalent Influenza Vaccine Administered Intramuscularly in Children/Adolescents and Adults

NCT01481454 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1701

Last updated 2013-03-29

No results posted yet for this study

Summary

The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age).

Primary Objective:

* To describe the safety profile (injection site reactions and systemic events) of each vaccine during the 21 days following vaccination, and serious adverse events (including adverse events of special interest) throughout the study in all adult and child/adolescent participants.

Secondary Objectives:

* To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine (QIV) induce an equivalent immune response at 21 days post-vaccination in both age groups (lot consistency)
* To describe the compliance of the immunogenicity of QIV to the European Medicines Agency Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group.

Conditions

Interventions

BIOLOGICAL

Quadrivalent Influenza Vaccine (split virion, inactivated)

0.5 mL, Intramuscular

BIOLOGICAL

Quadrivalent Influenza Vaccine (split virion, inactivated)

0.5 mL, Intramuscular

BIOLOGICAL

Quadrivalent Influenza Vaccine (split virion, inactivated)

0.5 mL, Intramuscular

BIOLOGICAL

2011 to 2012 Trivalent Influenza Vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • Australia
  • Philippines

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 NCT01481454 on ClinicalTrials.gov