Japanese Pediatric H5N1 Vaccine Study

Phase 3CompletedNCT01911754

Alachua Government Services, Inc.60 enrolled

Overview

The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese pediatric population aged 6 months to 17 years

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Influenza

Interventions

H5N1 (Pre-)Pandemic Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated)BIOLOGICAL

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participant is 6 months to 17 years old at time of screening. * Participant is born at full term of pregnancy (≥37 weeks) with a birth weight ≥2 kg (for participants aged 6 to 35 months only). * Participant is generally healthy, as determined by investigator's clinical judgment through collection of medical history and a physical examination. * If female of childbearing potential, participant has a negative pregnancy test within 24 hours prior to first scheduled vaccination and agrees to employ adequate birth control measures for study duration. * Participant and/or their parents/legal guardians is/are willing and able to comply with protocol requirements. Exclusion Criteria: * Participant has a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine. * Participant is at high risk of contracting H5N1 influenza infection (e.g. contact with poultry). * 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, dermatological condition or tattoos which may interfere with injection site reaction rating. * Participant has received a blood transfusion, immunoglobulins or other blood derivatives within 90 days prior to study entry. * Participant has donated blood or plasma within 30 days prior to study entry. * Participant has received any live vaccine within 4 weeks or 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 is pregnant or lactating at the time of enrollment. * Participant has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.

Locations (2)

Minami Clinic

Kagoshima, Kagoshima-ken, Japan

Shibahara Tahara Hospital

Kagoshima, Kagoshima-ken, 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

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

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

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

Evaluation of Immunogenicity by SRH Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination

Data from ClinicalTrials.gov

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