Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00664417

Collaborator

(none)

375

Enrollment

Locations

Arms

Duration (Months)

62.5

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.

Condition or Disease	Intervention/Treatment	Phase
Influenza Orthomyxoviridae Infections	Biological: Monovalent subvirion H5N1 influenza vaccine Biological: Monovalent subvirion H5N1 influenza vaccine Biological: Monovalent subvirion H5N1 influenza vaccine Biological: Monovalent subvirion H5N1 influenza vaccine Biological: Monovalent subvirion H5N1 influenza vaccine Biological: Monovalent subvirion H5N1 influenza vaccine Biological: Monovalent subvirion H5N1 influenza vaccine Biological: Monovalent subvirion H5N1 influenza vaccine Biological: Physiological saline	Phase 1

Detailed Description

This is a Phase I, observer-blinded, randomized, controlled multicenter, dose-finding study in adult subjects. All vaccines will be administered as a two-dose schedule in (H5N1) immunologically-naïve adults. Immunogenicity and safety will be evaluated after each injection.

Study Design

Study Type:

Interventional

Actual Enrollment :

375 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Safety and Immunogenicity of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine in Healthy Adults

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 1
Experimental: 2	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 2
Experimental: 3	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 3
Experimental: 4	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 4
Experimental: 5	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 5
Experimental: 6	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 6
Active Comparator: 7	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Comparator 1
Active Comparator: 8	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Comparator 2
Placebo Comparator: 9	Biological: Physiological saline 0.5 mL, IM, 2 injections

Outcome Measures

Primary Outcome Measures

To provide information concerning the safety after primary administration of A/H1N1 vaccine [6 months post-vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria :

Healthy adult aged 18 to 40 years on the day of inclusion.
Provides signed informed consent prior to study procedures.
Able to attend all scheduled visits and comply with all trial procedures.
For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.

Exclusion Criteria :

Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances
For a woman of child-bearing potential, known pregnancy or positive serum/urine pregnancy test
Breast feeding woman
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the (first) trial vaccination
Planned participation in another clinical trial during the present trial period
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, oral, parenteral, or inhaled steroids
Has an acute or chronic medical illness or any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or would interfere with the evaluation of responses or render the subject unable to meet the requirements of the protocol
Known or suspected current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
History of receipt of blood or immunoglobulin or other blood-derived products within the 3 months prior to enrollment in this study 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 preceding or following any trial vaccination
Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C seropositivity
Personal or family history of Guillain-Barré Syndrome
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
Active neoplastic disease or a history of any hematologic malignancy
Previous participation in a pandemic flu trial
History of H5N1 infection or exposure to presumed/confirmed H5N1 human/animal cases
Known seizure/epilepsy history and/or taking anti-seizure medication
Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study.
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	San Diego	California	United States	92103
2	South Miami	Florida	United States	33143
3	Springfield	Missouri	United States	65802
4	Cincinnati	Ohio	United States	45219
5	Cincinnati	Ohio	United States	45227
6	Knoxville	Tennessee	United States	37920