Japanese Pediatric H5N1 Vaccine Study

NCT ID: NCT01911754

Last Updated: 2015-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Interventions

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baxter Innovations GmbH

INDUSTRY

Sponsor Role: collaborator

Alachua Government Services, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nirjhar Chatterjee, MD

Role: STUDY_DIRECTOR

Baxter Innovations GmbH

Locations

Minami Clinic

Kagoshima, Kagoshima-ken, Japan

Shibahara Tahara Hospital

Kagoshima, Kagoshima-ken, Japan

Countries

Japan

Other Identifiers

811202

Identifier Type: -

Identifier Source: org_study_id