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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01032980
First received: December 15, 2009
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Phase
Influenza
Swine-Origin A/H1N1 Influenza
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety: To provide information concerning the safety of HUMENZA and PANENZA vaccines. [ Time Frame: 21 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 3934
Study Start Date: December 2009
Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   2 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032980

Locations
France
Bordeaux, France, 33000
Lille, France, 59000
Lyon, France, 69000
Marseille, France, 13000
Paris, France, 75000
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Monitor, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier: NCT01032980     History of Changes
Other Study ID Numbers: GPF11, UTN: U1111-1112-2748
Study First Received: December 15, 2009
Last Updated: July 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
HUMENZA
PANENZA
Influenza
Swine-Origin Influenza A H1N1 Virus
Influenza virus vaccines

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013