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Clinical Trials/NCT00884182
NCT00884182
Completed
Phase 2

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

Sanofi Pasteur, a Sanofi Company0 sites350 target enrollmentApril 2009
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ConditionsInfluenzaOrthomyxoviridae InfectionsOrthomyxovirus Infections

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Influenza
Sponsor
Sanofi Pasteur, a Sanofi Company
Enrollment
350
Primary Endpoint
To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine.
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief 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.

Detailed Description

Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
June 2010
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine.

Time Frame: 21 days post-vaccination and entire study

Secondary Outcomes

  • To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine.(21 days post-vaccination)

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