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Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

NCT00491985 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2014-01-14

No results posted yet for this study

Summary

This is an open, randomized, multicenter clinical trial.

Objectives:

* To describe the safety profiles during the 21 days following each primary and booster injection.
* To describe the immune response 21 days after each primary and booster injection of each formulation.
* To describe the antibody persistence after the first vaccination

Conditions

  • Influenza
  • Orthomyxoviridae Infections
  • Influenza A Virus Infection

Interventions

BIOLOGICAL

A/H5N1 Inactivated, split-virion pandemic influenza vaccine

0.5 mL, Intramuscular

BIOLOGICAL

A/H5N1 Inactivated, split virion pandemic influenza vaccine

0.5 mL, Intramuscular

BIOLOGICAL

A/H5N1 Inactivated, split virion pandemic influenza vaccine

0.25 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-12-31
Completion
2010-06-30

Countries

  • Thailand

Study Locations

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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 NCT00491985 on ClinicalTrials.gov