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

NCT01032980 | Completed

• 2 other identifiers: GPF11UTN: U1111-1112-2748
• Study Type: observational
• Target: 3,934
• Locations: 1 country
• Sites: 5

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.

Conditions

Influenza; Swine-Origin A/H1N1 Influenza Virus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety: To provide information concerning the safety of HUMENZA and PANENZA vaccines.

  21 days post-vaccination and entire study duration

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Participant previously vaccinated with another A/H1N1 pandemic vaccine

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (5)

Unknown Facility

Bordeaux, 33000, France

Location

Unknown Facility

Lille, 59000, France

Location

Unknown Facility

Lyon, 69000, France

Location

Unknown Facility

Marseille, 13000, France

Location

Unknown Facility

Paris, 75000, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

FR (5)