H5N1 Vaccine Study in Japanese Adults

H5N1 Influenza Clinical Trial

Official title:

A Blinded, Randomized Phase 2/3 Study to Assess Immunogenicity and Safety of Two Different Dose Levels of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Japanese Adult Population Aged 18 to 59 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382329
• Other study ID #: 811001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 24, 2011
• Last updated: October 7, 2015
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2012
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: May 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• H5N1 Influenza
• Influenza, Human

Intervention

Biological:
• H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)
Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Locations

Country	Name	City	State
Japan	Medical Co. LTA PS Clinic	Fukuoka-shi	Fukuoka-Ken
Japan	CPC Clinic, Medipolis Medical Research Institute	Kagoshima-shi	Kagoshima-Ken
Japan	Osaka Pharmacology Clinical Research Hospital	Osaka-shi	Osaka-Fu

Sponsors (2)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.	Baxter Innovations GmbH

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with antibody response to the vaccine strain	Measurement by single radial hemolysis (SRH) assay	21 days after 2nd vaccination	No
Primary	Number of subjects demonstrating seroconversion	Measurement by SRH assay	21 days after 2nd vaccination	No
Primary	Fold increase of antibody response	Measurement by SRH assay	21 days after 2nd vaccination	No
Secondary	Number of subjects with antibody response to the vaccine strain	Measurement by SRH (except at 21 days after 2nd vaccination), microneutralization (MN) and hemagglutination inhibition (HI) assay	21 days after 1st and 21+180 days after 2nd vaccination	No
Secondary	Number of subjects demonstrating seroconversion	Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay	21 days after 1st and 21+180 days after 2nd vaccination	No
Secondary	Antibody response	Measurement by SRH, MN and HI assay	21 days after 1st and 21 + 180 days after 2nd vaccination	No
Secondary	Fold increase of antibody response	Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay	21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline	No