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

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ClinicalTrials.gov Identifier: NCT01032980
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.


Condition or disease Phase
Influenza Swine-Origin A/H1N1 Influenza Virus Phase 4

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
Actual Enrollment : 3934 participants
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
Study Start Date : December 2009
Primary Completion Date : January 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

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.



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032980


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

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01032980     History of Changes
Other Study ID Numbers: GPF11
UTN: U1111-1112-2748 ( Other Identifier: WHO )
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs