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

September 25, 2015 updated by: Sanofi Pasteur, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

3934

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
      • Lille, France, 59000
      • Lyon, France, 69000
      • Marseille, France, 13000
      • Paris, France, 75000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPF11
  • UTN: U1111-1112-2748 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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