Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
This study has been completed.
Sponsor:
Sanofi-Aventis
Information provided by:
Sanofi-Aventis
ClinicalTrials.gov Identifier:
NCT00545701
First received: October 15, 2007
Last updated: September 23, 2008
Last verified: September 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Orthomyxoviridae Infections |
Biological: A/H5N1 inactivated, split-virion influenza virus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
Resource links provided by NLM:
Further study details as provided by Sanofi-Aventis:
Primary Outcome Measures:
- To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine [ Time Frame: Day 42 post-vaccination 1 ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | October 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: A/H5N1 inactivated, split-virion influenza virus
0.5 mL, Intramuscular
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Aged 18 to 60 years on day of inclusion.
- 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.
Exclusion Criteria:
- 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).
- Febrile illness (oral temperature >= 37.5°C) on the day of inclusion.
- 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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT00545701 History of Changes |
| Other Study ID Numbers: | GPA11 |
| Study First Received: | October 15, 2007 |
| Last Updated: | September 23, 2008 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Sanofi-Aventis:
|
Influenza A/H5N1 strain Orthomyxoviridae Infections Influenza Pandemics |
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 October 17, 2012
