Post Authorization Safety Study of the Pandemic A/H1N1 Influenza Vaccines in Children and Adults
- Conditions
- InfluenzaSwine-Origin A/H1N1 Influenza Virus
- Registration Number
- NCT01032980
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.
Primary objective:
To describe the incidence of serious adverse events and adverse events of special interest (AESIs) after HUMENZA or PANENZA administration throughout the study in different age groups.
Secondary objective:
To describe the incidence of non-serious cutaneous allergic reactions after HUMENZA or PANENZA administration in different age groups up to 21 days after the last vaccination.This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.
- Detailed Description
All participants will be vaccinated with study vaccines (1 or 2 doses) at the start of the study and will be monitored for safety for up to 6 months after the last vaccination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3934
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: To provide information concerning the safety of HUMENZA and PANENZA vaccines. 21 days post-vaccination and entire study duration
- Secondary Outcome Measures
Name Time Method