Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-03-31

Brief Summary

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Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (\> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.

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Detailed Description

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Conditions

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Influenza Orthomyxoviridae Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study Group 1

Vaccine with adjuvant

Group Type EXPERIMENTAL

A/H5N1 inactivated, split-virion influenza virus

Intervention Type BIOLOGICAL

0.5mL, Intramuscular

Study Group 2

Vaccine without adjuvant

Group Type EXPERIMENTAL

A/H5N1 inactivated, split-virion influenza virus

Intervention Type BIOLOGICAL

0.5mL, Intramuscular

Interventions

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A/H5N1 inactivated, split-virion influenza virus

0.5mL, Intramuscular

Intervention Type BIOLOGICAL

A/H5N1 inactivated, split-virion influenza virus

0.5mL, Intramuscular

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Aged over 18 years on the 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 and at least 4 weeks after to 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
* 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 within the past 3 months
* Any vaccination within 4 weeks prior to the first trial vaccination
* Vaccination planned within 4 weeks after 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes