- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01911754
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- 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
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Kagoshima-ken
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Kagoshima-shi, Kagoshima-ken, Japan, 890-0063
- Minami Clinic
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Kagoshima-shi, Kagoshima-ken, Japan, 890-0082
- Shibahara Tahara Hospital
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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
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 |
Intervention / Treatment |
---|---|
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
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What is the study measuring?
Primary Outcome Measures
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
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Associated with protection 21 days after second vaccination defined as hemolysis area measured by SRH assay ≥25mm^2
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Day 43
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Co-Primary Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the second vaccination
Time Frame: Day 43
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'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.
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Day 43
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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
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Day 43
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Secondary Outcome Measures
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
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Associated with protection 21 days after the first and 180 days after the second vaccination defined as SRH area ≥25mm^2
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Days 22 and 202
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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.
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Days 22 and 202
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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
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Days 22, 43 and 202
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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
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Days 22 and 202
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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
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Associated with protection 21 days after the first and 21 and 180 days after the second vaccination defined as MN titer ≥ 1:20
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Days 22, 43 and 202
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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
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'Seroconversion' is defined as a four-fold or greater increase in titer as compared to baseline.
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Days 22, 43 and 202
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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
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Days 22, 43 and 202
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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
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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
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Associated with protection 21 days after the first and 21 and 180 days after second vaccination defined as HI titer ≥ 1:40
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Days 22, 43 and 202
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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
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'Seroconversion' is defined as a 4-fold or greater increase in HI titer as compared to baseline
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Days 22, 43 and 202
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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
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Days 22, 43 and 202
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|
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
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Days 22, 43 and 202
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Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations
Time Frame: Through study day 43
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Through study day 43
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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
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Days 1-7 and days 22-28
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Frequency and severity of all adverse events (AEs) observed during the entire study period
Time Frame: Through day 202
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Through day 202
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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
August 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
July 26, 2013
First Submitted That Met QC Criteria
July 26, 2013
First Posted (Estimate)
July 30, 2013
Study Record Updates
Last Update Posted (Estimate)
October 9, 2015
Last Update Submitted That Met QC Criteria
October 7, 2015
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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