Clinical trial NCT01911754: Japanese Pediatric H5N1 Vaccine Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Baxter Innovations GmbH
First posted: 2013-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Co-Primary Evaluation of Immunogenicity by Single Radial Hemolysis (SRH) Assay: Number of participants with antibody response to vaccine strain (A/Indonesia/05/2005)
timeFrame: Day 43
measure: Co-Primary Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the second vaccination
timeFrame: Day 43
measure: Co-Primary Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the second vaccination as compared to baseline
timeFrame: Day 43
Secondary outcomes:
measure: Evaluation of Immunogenicity by SRH Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
timeFrame: Days 22 and 202
measure: Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the first and 180 days after the second vaccination
timeFrame: Days 22 and 202
measure: Evaluation of Immunogenicity by SRH Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination
timeFrame: Days 22, 43 and 202
measure: 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
timeFrame: Days 22 and 202
measure: Evaluation of Immunogenicity by Microneutralization (MN) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
timeFrame: Days 22, 43 and 202
measure: 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
timeFrame: Days 22, 43 and 202
measure: 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
timeFrame: Days 22, 43 and 202
measure: Evaluation of Immunogenicity by MN Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination
timeFrame: Days 22, 43 and 202
measure: 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
timeFrame: Days 22, 43 and 202
measure: Evaluation of Immunogenicity by Hemagglutination Inhibition (HI) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)
timeFrame: Days 22, 43 and 202
measure: 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
timeFrame: Days 22, 43 and 202
measure: Evaluation of Immunogenicity by HI Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination
timeFrame: Days 22, 43 and 202
measure: 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
timeFrame: Days 22, 43 and 202
measure: Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations
timeFrame: Through study day 43
measure: 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.
timeFrame: Days 1-7 and days 22-28
measure: Frequency and severity of all adverse events (AEs) observed during the entire study period
timeFrame: Through day 202
Other outcomes:
Locations:
city: Kagoshima-shi
country: Japan
facility: Minami Clinic
state: Kagoshima-ken
city: Kagoshima-shi
country: Japan
facility: Shibahara Tahara Hospital
state: Kagoshima-ken
Study officials:
affiliation: Baxter Innovations GmbH
name: Nirjhar Chatterjee, MD
role: STUDY_DIRECTOR
References: