Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00457509
First received: April 5, 2007
Last updated: April 15, 2011
Last verified: April 2011
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Purpose
The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity
Primary Objective:
To describe the safety profile and immunogenicity following each injection.
| Condition | Intervention | Phase |
|---|---|---|
|
Pandemic Influenza Influenza A Virus Infection Orthomyxoviridae Infections |
Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant Biological: A/H5N1 inactivated, split-virion influenza vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine [ Time Frame: Entire study period ] [ Designated as safety issue: Yes ]
| Enrollment: | 251 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Dose 1 with Adjuvant
|
Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
|
|
Experimental: Group 2
Dose 2 with adjuvant
|
Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
|
|
Experimental: Group 3
Dose 3 with adjuvant
|
Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
|
|
Experimental: Group 4
Dose 4 with adjuvant
|
Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
|
|
Active Comparator: Group 5
Control
|
Biological: A/H5N1 inactivated, split-virion influenza vaccine
0.5 mL, Intramuscular
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria :
- Aged 18 to 40 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.
Exclusion Criteria :
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Previous participation in a clinical trial involving an investigational flu pandemic vaccine.
- Vaccination with an influenza vaccine during the past 6 months
- Any vaccination in the 4 weeks preceding the first trial vaccination
- Vaccination planned in the 4 weeks following any trial vaccination
- Breast-feeding.
- For a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
- Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C seropositivity.
- Known systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Blood or blood-derived products received in the past 3 months.
- Febrile illness (temperature ≥ 37.5°C) on the day of inclusion.
- Laboratory abnormalities considered clinically significant upon the Investigator's judgment in blood sample taken at screening (for Step 1 only)
Contacts and Locations More Information
Additional Information:
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT00457509 History of Changes |
| Other Study ID Numbers: | GPF01 |
| Study First Received: | April 5, 2007 |
| Last Updated: | April 15, 2011 |
| Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Keywords provided by Sanofi:
|
Pandemic influenza Avian influenza Orthomyxoviridae Infections A/H5N1 |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections Virus Diseases RNA Virus Infections Respiratory Tract Infections |
Respiratory Tract Diseases Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013