Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults

NCT00545701 | Completed Phase 2

• 1 other identifier: GPA11
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies. Objectives:

• To describe the immune response 21 days after each vaccination.
• To describe the safety profiles following each vaccination.

Conditions

Influenza; Orthomyxoviridae Infections

Keywords

Influenza; A/H5N1 strain; Orthomyxoviridae Infections; Influenza Pandemics

Outcome Measures

Primary Outcomes (1)

• To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine

  Day 42 post-vaccination 1

Study Arms (1)

1

EXPERIMENTAL

Biological: A/H5N1 inactivated, split-virion influenza virus

Interventions

A/H5N1 inactivated, split-virion influenza virus BIOLOGICAL

0.5 mL, Intramuscular

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent Form signed.
• Able to attend all scheduled visits and to comply with all trial procedures.
• For a woman, inability to bear a child or negative urine pregnancy test.
• For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination.

You may not qualify if:

• Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
• Breast-feeding.
• Previous vaccination with an avian flu vaccine.
• Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
• Planned participation in another clinical trial during the present trial period.
• Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
• Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
• Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures.
• Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
• Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Adelaide, Australia

Location

Unknown Facility

Queensland, Australia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 17, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

AU (2)