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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3934 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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

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Influenza Swine-Origin A/H1N1 Influenza Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HUMENZA Vaccine Group

Participants vaccinated with HUMENZA according to the recommendations provided in the product leaflet and local recommendations.

No interventions assigned to this group

PANENZA Vaccine Group

Participants vaccinated with PANENZA according to the recommendations provided in the product leaflet and local recommendations.

No interventions assigned to this group

Eligibility Criteria

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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