NCT01911754CompletedPhase 3
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
Resilience Government Services, Inc.4 sites in 1 country60 target enrollmentStarted: August 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Co-Primary Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the second vaccination as compared to baseline
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
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.
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
Secondary Outcomes
- Evaluation of Immunogenicity by SRH Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)(Days 22 and 202)
- Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations(Through study day 43)
- 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(Days 22, 43 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(Days 22 and 202)
- Evaluation of Immunogenicity by Hemagglutination Inhibition (HI) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)(Days 22, 43 and 202)
- Evaluation of Immunogenicity by Microneutralization (MN) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)(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(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(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(Days 22, 43 and 202)
- 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.(Days 1-7 and days 22-28)
- Evaluation of Immunogenicity by SRH Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination(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(Days 22 and 202)
- Evaluation of Immunogenicity by MN Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination(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(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(Days 22, 43 and 202)
- Frequency and severity of all adverse events (AEs) observed during the entire study period(Through day 202)
Investigators
Study Sites (4)
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