H5N1 Vaccine Study in Japanese Elderly Population Aged 65 Years and Older

Alachua Government Services, Inc.91 enrolled

Overview

The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese elderly population aged 65 years and older.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Influenza

Interventions

H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulationBIOLOGICAL

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participant is 65 years or older at the time of screening. * Participant is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination. * Participant is physically and mentally capable of participating in the study. * Participant is willing and able to comply with the requirements of the protocol. Exclusion Criteria: * Participant has a history of infection with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine. * Participant is at high risk of contracting H5N1 influenza infection (e.g., poultry workers). * Participant 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. * Participant has any inherited or acquired immunodeficiency. * Participant 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. * Participant has a history of severe allergic reactions or anaphylaxis. * Participant has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating. * Participant has received a blood transfusion or immunoglobulins within 90 days prior to study entry. * Participant has donated blood or plasma within 30 days prior to study entry. * Participant 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. * Participant has a functional or surgical asplenia. * Participant has a known or suspected problem with alcohol or drug abuse. * Participant has been exposed to an investigational product (IP) within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study. * Participant is a family member or employee of the investigator. * Participant has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.

Locations (2)

PS Clinic

Fukuoka, Japan

Osaka Pharmacology Clinical Research Hospital (OPHAC Hospital)

Osaka, Japan

Outcomes

Primary Outcomes

Co-Primary Evaluation of Immunogenicity by Single Radial Hemolysis (SRH) Assay: Number of participants with antibody response to vaccine strain (A/Indonesia/05/2005)

Associated with protection 21 days after second vaccination defined as hemolysis area measured by SRH assay ≥25mm\^2

Time frame: Day 43 (42 days after first vaccination, 21 days after second vaccination)

Co-Primary Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the second vaccination

'Seroconversion' is defined as either a ≥25mm\^2 hemolysis area after the vaccination in case of a negative prevaccination sample (≤4mm\^2) or a ≥50% increase in hemolysis area if the prevaccination sample is \>4mm\^2.

Time frame: Day 43 (42 days after first vaccination, 21 days after second vaccination)

Co-Primary Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the second vaccination as compared to baseline

Time frame: Day 43 (42 days after first vaccination, 21 days after second vaccination)

Secondary Outcomes

Evaluation of Immunogenicity by SRH Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

Associated with protection 21 days after the first and 180 days after the second vaccination defined as SRH area ≥25mm\^2

Time frame: Days 22 and 202

Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the first and 180 days after the second vaccination

'Seroconversion' is defined as either a ≥25mm\^2 hemolysis area after the vaccination in case of a negative prevaccination sample \[≤4mm\^2\] or a ≥50% increase in hemolysis area if the prevaccination sample is \>4mm\^2.

Time frame: Days 22 and 202

Data from ClinicalTrials.gov

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