Japanese Pediatric H5N1 Vaccine Study

October 7, 2015 updated by: Ology Bioservices

An Open-Label Phase 3 Study to Assess Immunogenicity and Safety of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Japanese Pediatric Population Aged 6 Months to 17 Years

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kagoshima-ken
      • Kagoshima-shi, Kagoshima-ken, Japan, 890-0063
        • Minami Clinic
      • Kagoshima-shi, Kagoshima-ken, Japan, 890-0082
        • Shibahara Tahara Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Influenza Vaccine
One dose of the vaccine will be administered at a volume of 0.5 mL by intramuscular injection on Day 1 and 22
Biological: H5N1 (Pre-)Pandemic Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Co-Primary Evaluation of Immunogenicity by Single Radial Hemolysis (SRH) Assay: Number of participants with antibody response to vaccine strain (A/Indonesia/05/2005)
Time Frame: Day 43
Associated with protection 21 days after second vaccination defined as hemolysis area measured by SRH assay ≥25mm^2
Day 43
Co-Primary Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the second vaccination
Time Frame: Day 43
'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.
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
Day 43

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of Immunogenicity by SRH Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
Time Frame: Days 22 and 202
Associated with protection 21 days after the first and 180 days after the second vaccination defined as SRH area ≥25mm^2
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
Time Frame: Days 22 and 202
'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.
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
Time Frame: Days 22, 43 and 202
Days 22, 43 and 202
Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the first and 180 days after the second vaccination as compared to baseline
Time Frame: Days 22 and 202
Days 22 and 202
Evaluation of Immunogenicity by Microneutralization (MN) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
Time Frame: Days 22, 43 and 202
Associated with protection 21 days after the first and 21 and 180 days after the second vaccination defined as MN titer ≥ 1:20
Days 22, 43 and 202
Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination
Time Frame: Days 22, 43 and 202
'Seroconversion' is defined as a four-fold or greater increase in titer as compared to baseline.
Days 22, 43 and 202
Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating either ≥4-fold titer increase compared to baseline if above detection limit OR a ≥ 20 titer after vaccination if baseline titer is below detection limit
Time Frame: Days 22, 43 and 202
Days 22, 43 and 202
Evaluation of Immunogenicity by MN Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination
Time Frame: Days 22, 43 and 202
Days 22, 43 and 202
Evaluation of Immunogenicity by MN Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline
Time Frame: Days 22, 43 and 202
Days 22, 43 and 202
Evaluation of Immunogenicity by Hemagglutination Inhibition (HI) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
Time Frame: Days 22, 43 and 202
Associated with protection 21 days after the first and 21 and 180 days after second vaccination defined as HI titer ≥ 1:40
Days 22, 43 and 202
Evaluation of Immunogenicity by HI Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination
Time Frame: Days 22, 43 and 202
'Seroconversion' is defined as a 4-fold or greater increase in HI titer as compared to baseline
Days 22, 43 and 202
Evaluation of Immunogenicity by HI Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination
Time Frame: Days 22, 43 and 202
Days 22, 43 and 202
Evaluation of Immunogenicity by HI Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline
Time Frame: Days 22, 43 and 202
Days 22, 43 and 202
Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations
Time Frame: Through study day 43
Through study day 43
Number of participants with fever, malaise or shivering (in children and adolescents aged 3 to 17 years) and fever and irritability (in infants and young children aged 6 to 35 months) with onset within 7 days after the first and second vaccinations.
Time Frame: Days 1-7 and days 22-28
Days 1-7 and days 22-28
Frequency and severity of all adverse events (AEs) observed during the entire study period
Time Frame: Through day 202
Through day 202

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ology Bioservices

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxter Innovations GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nirjhar Chatterjee, MD, Baxter Innovations GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 811202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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