MedTrace Logo

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)

NCT01691326 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-04-16

Study results available
· View outcomes & findings →

Summary

The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine.

Objective:

* To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age.

Observational Objectives:

* To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to \< 9 years of age.
* To submit remaining available sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.

Conditions

Interventions

BIOLOGICAL

Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose

0.25 mL dose, Intramuscular

BIOLOGICAL

Fluzone®; Influenza Virus Vaccine, No Preservative

0.5 mL dose, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-12-31
Completion
2013-02-28

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 NCT01691326 on ClinicalTrials.gov