Clinical trial NCT01032980: Post Authorization Safety Study of the Pandemic A/H1N1 Influenza Vaccines in Children and Adults
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Swine-Origin A/H1N1 Influenza Virus
Keywords: HUMENZA
PANENZA
Influenza
Swine-Origin Influenza A H1N1 Virus
Influenza virus vaccines
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 3934
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be vaccinated with HUMENZA or PANENZA according to the recommendations provided in the product leaflet and local recommendations.

The HUMENZA Group will be divided in 6 defined age groups; the PANENZA Group will be divided into 2 defined age groups.

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.

Eligibility 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

Primary outcomes:
measure: Safety: To provide information concerning the safety of HUMENZA and PANENZA vaccines.
timeFrame: 21 days post-vaccination and entire study duration
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Paris
country: France
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: