NCT01032980

Post Authorization Safety Study of the Pandemic A/H1N1 Influenza Vaccines in Children and Adults

Post Authorization Safety Study of the Intramuscular Inactivated, Split Virion Pandemic A/H1N1 Influenza Vaccines in Children Aged Over 2 Months and in Adult Populations

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,934 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Months
• Healthy volunteers: Accepted

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.

Conditions

• Influenza
• Swine-Origin A/H1N1 Influenza Virus

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-01-01
• Completion: 2011-07-01
• First posted: 2009-12-16
• Last updated: 2015-09-28

Locations

5 sites across 1 country: France