Japanese Pediatric H5N1 Vaccine Study

NCT01911754 | Completed Phase 3 DMC

• 1 other identifier: 811202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

• Co-Primary Evaluation of Immunogenicity by Single Radial Hemolysis (SRH) Assay: Number of participants with antibody response to vaccine strain (A/Indonesia/05/2005)

  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

  '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

  Day 43

Secondary Outcomes (16)

• Evaluation of Immunogenicity by SRH Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

  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

  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

  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 Microneutralization (MN) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

  Days 22, 43 and 202

Study Arms (1)

Influenza Vaccine

EXPERIMENTAL

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)

Interventions

H5N1 (Pre-)Pandemic Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated) BIOLOGICAL

Influenza Vaccine

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead
• Baxter Innovations GmbH: collaborator

Study Sites (2)

Minami Clinic

Kagoshima, Kagoshima-ken, 890-0063, Japan

Location

Shibahara Tahara Hospital

Kagoshima, Kagoshima-ken, 890-0082, Japan

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Nirjhar Chatterjee, MD

  Baxter Innovations GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 30, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: October 9, 2015

Record last verified: 2014-05

Locations

JP (2)