Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children
Phase 2
Completed
- Conditions
- InfluenzaOrthomyxoviridae InfectionsOrthomyxovirus Infections
- Interventions
- Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
- Registration Number
- NCT00884182
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine Participants on vaccination schedule 1 (Day 0 and Day 21) Group 2 A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine Participants on vaccination schedule 2 (Day 0 and Day 14) Group 3 A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine Participants on vaccination schedule 3 (Day 0 and Day 42)
- Primary Outcome Measures
Name Time Method To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine. 21 days post-vaccination and entire study
- Secondary Outcome Measures
Name Time Method To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine. 21 days post-vaccination