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

Resilience Government Services, Inc.3 sites in 1 country340 target enrollmentJune 2011

ConditionsH5N1 Influenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: H5N1 Influenza
Sponsor: Resilience Government Services, Inc.
Enrollment: 340
Locations: 3
Primary Endpoint: Number of subjects demonstrating seroconversion
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

May 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Resilience Government Services, Inc.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Number of subjects demonstrating seroconversion

Time Frame: 21 days after 2nd vaccination

Measurement by SRH assay

Fold increase of antibody response

Time Frame: 21 days after 2nd vaccination

Measurement by SRH assay

Number of subjects with antibody response to the vaccine strain

Time Frame: 21 days after 2nd vaccination

Measurement by single radial hemolysis (SRH) assay

Secondary Outcomes

Number of subjects with antibody response to the vaccine strain(21 days after 1st and 21+180 days after 2nd vaccination)
Number of subjects demonstrating seroconversion(21 days after 1st and 21+180 days after 2nd vaccination)
Antibody response(21 days after 1st and 21 + 180 days after 2nd vaccination)
Fold increase of antibody response(21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline)