MedTrace Logo

Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children

NCT00884182 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2014-01-14

No results posted yet for this study

Summary

This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic.

Study objectives:

* To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule.
* To describe the immune response after each vaccination in subjects receiving study vaccine.

Conditions

  • Influenza
  • Orthomyxoviridae Infections
  • Orthomyxovirus Infections

Interventions

BIOLOGICAL

A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine

0.5 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
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-03-31
Completion
2010-06-30

Countries

  • Finland

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 NCT00884182 on ClinicalTrials.gov