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

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Sanofi

Status

Completed

Conditions

Influenza
Swine-Origin A/H1N1 Influenza Virus

Study type

Observational

Funder types

Industry

Identifiers

NCT01032980
UTN: U1111-1112-2748 (Other Identifier)
GPF11

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,934 patients

Sex

All

Ages

2+ months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

  • Aged 2 months and above on the day of inclusion
  • Having received HUMENZA or PANENZA
  • Provision of the Contact Order Form (COF) signed by the participant or the participant's parent(s)/guardians(s)
  • Participant or the participant's parent(s)/legal representative(s) are able to attend all scheduled visits and to comply with all study procedures

Exclusion Criteria :

Participant previously vaccinated with another A/H1N1 pandemic vaccine

Trial design

3,934 participants in 2 patient groups

HUMENZA Vaccine Group
Description:
Participants vaccinated with HUMENZA according to the recommendations provided in the product leaflet and local recommendations.
PANENZA Vaccine Group
Description:
Participants vaccinated with PANENZA according to the recommendations provided in the product leaflet and local recommendations.

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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