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Japanese Pediatric H5N1 Vaccine Study

This study has been completed.
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01911754
First received: July 26, 2013
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Influenza
Biological: H5N1 (Pre-)Pandemic Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Associated with protection 21 days after second vaccination defined as hemolysis area measured by SRH assay ≥25mm^2

  • Co-Primary Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the second vaccination [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
    '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 SRH Assay: Fold increase of antibody response 21 days after the second vaccination as compared to baseline [ Time Frame: Day 43 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Associated with protection 21 days after the first and 180 days after the second vaccination defined as SRH area ≥25mm^2

  • 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 ] [ Designated as safety issue: No ]
    '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.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Associated with protection 21 days after the first and 21 and 180 days after the second vaccination defined as MN titer ≥ 1:20

  • 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 ] [ Designated as safety issue: No ]
    'Seroconversion' is defined as a four-fold or greater increase in titer as compared to baseline.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Associated with protection 21 days after the first and 21 and 180 days after second vaccination defined as HI titer ≥ 1:40

  • 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 ] [ Designated as safety issue: No ]
    'Seroconversion' is defined as a 4-fold or greater increase in HI titer as compared to baseline

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations [ Time Frame: Through study day 43 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Frequency and severity of all adverse events (AEs) observed during the entire study period [ Time Frame: Through day 202 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: August 2013
Study Completion Date: April 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911754

Locations
Japan
Minami Clinic
Kagoshima-shi, Kagoshima-ken, Japan, 890-0063
Shibahara Tahara Hospital
Kagoshima-shi, Kagoshima-ken, Japan, 890-0082
Sponsors and Collaborators
Baxter Healthcare Corporation
Baxter Innovations GmbH
Investigators
Study Director: Nirjhar Chatterjee, MD Baxter Innovations GmbH
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01911754     History of Changes
Other Study ID Numbers: 811202
Study First Received: July 26, 2013
Last Updated: May 22, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014