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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01032980

Enrollment

3934

Registered

2009-12-16

Start date

2009-12-31

Completion date

2011-07-31

Last updated

2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Swine-Origin A/H1N1 Influenza Virus

Keywords

HUMENZA, PANENZA, Influenza, Swine-Origin Influenza A H1N1 Virus, Influenza virus vaccines

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety: To provide information concerning the safety of HUMENZA and PANENZA vaccines.	21 days post-vaccination and entire study duration

Countries

France

Outcome results