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

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.

Study Overview

• Status: Completed
• Conditions: Orthomyxoviridae Infections; Pandemic Influenza; Influenza A Virus Infection
• Intervention / Treatment: Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant; Biological: A/H5N1 inactivated, split-virion influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
  • Gent, Belgium
  • Leuven, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine	Entire study period

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

General Publications

• Levie K, Leroux-Roels I, Hoppenbrouwers K, Kervyn AD, Vandermeulen C, Forgus S, Leroux-Roels G, Pichon S, Kusters I. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J Infect Dis. 2008 Sep 1;198(5):642-9. doi: 10.1086/590913.

Helpful Links

• Related Info
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Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: April 5, 2007
• First Submitted That Met QC Criteria: April 5, 2007
• First Posted (Estimate): April 6, 2007

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 10, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: A/H5N1; Pandemic influenza; Avian influenza; Orthomyxoviridae Infections
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: GPF01