Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults

Sanofi

Status and phase

Completed

Phase 1

Conditions

Influenza A Virus Infection

Pandemic Influenza

Orthomyxoviridae Infections

Treatments

Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00457509

GPF01

Details and patient eligibility

About

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.

Enrollment

251 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

251 participants in 5 patient groups

Group 1

Experimental group

Description:

Dose 1 with Adjuvant

Treatment:

Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Group 2

Experimental group

Description:

Dose 2 with adjuvant

Treatment:

Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Group 3

Experimental group

Description:

Dose 3 with adjuvant

Treatment:

Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Group 4

Experimental group

Description:

Dose 4 with adjuvant

Treatment:

Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Group 5

Active Comparator group

Description:

Control

Treatment:

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

Trial contacts and locations

3

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