H5N1 Vaccine Study in Japanese Adults

NCT ID: NCT01382329

Last Updated: 2015-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-05-31

Brief Summary

The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years.

Conditions

H5N1 Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Treatment group I / Intramuscular

85 subjects to receive 2 intramuscular vaccinations at Dose A on Days 1 and 22

Group Type: EXPERIMENTAL

H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)

Intervention Type: BIOLOGICAL

Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Treatment group II / Intramuscular

85 subjects to receive 2 intramuscular vaccinations at Dose B on Days 1 and 22

Group Type: EXPERIMENTAL

H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)

Intervention Type: BIOLOGICAL

Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Treatment group III / Subcutaneous

85 subjects to receive 2 subcutaneous vaccinations at Dose A on Days 1 and 22

Group Type: EXPERIMENTAL

H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)

Intervention Type: BIOLOGICAL

Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Treatment group IV / Subcutaneous

85 subjects to receive 2 subcutaneous vaccinations at Dose B on Days 1 and 22

Group Type: EXPERIMENTAL

H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)

Intervention Type: BIOLOGICAL

Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Interventions

H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)

Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subject is 18 to 59 years old at the time of screening
• Subject is generally healthy, as determined by the investigator´s clinical judgement through collection of medical history and performance of a physical examination
• Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
• If female of childbearing potential, subject presents with a negative urine pregnancy test result within 24 hours prior ot the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria

• Subject has a history of infectin with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine
• Subject is at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
• Subject currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder
• Subject has any inherited or acquired immunodeficiency
• Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to: systemic or inhaled corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs
• Subject has a history of severe allergic reactions or anaphylaxis
• Subject has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
• Subject has received a blood transfusion or immunoglobulins within 90 days prior to study entry
• Subject has donated blood or plasma within 30 days prior to study entry
• Subject has received any influenza or any live vaccine within 4 weeks or any other inactivated vaccine within 2 weeks prior to vaccination in this study
• Subject has a functional or surgical asplenia
• Subject has a known or suspected problem with alcohol or drug abuse
• Subject was administered an investigational drug within 6 weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product
• Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator/subinvestigator or site personnel conducting the study
• If female, subject is pregnant or lactating at the time of enrollment
• Subject has any other condition that disqualifies his/her participation in the study in the opinion of the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baxter Innovations GmbH

INDUSTRY

Sponsor Role: collaborator

Alachua Government Services, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Geisberger, MD

Role: STUDY_DIRECTOR

Baxter Innovations GmbH

Locations

Medical Co. LTA PS Clinic

Fukuoka, Fukuoka, Japan

CPC Clinic, Medipolis Medical Research Institute

Kagoshima, Kagoshima-ken, Japan

Osaka Pharmacology Clinical Research Hospital

Osaka, Osaka, Japan

Countries

Japan

Other Identifiers

811001

Identifier Type: -

Identifier Source: org_study_id