Clinical trial NCT01382329: H5N1 Vaccine Study in Japanese Adults
Official title: A Blinded, Randomized Phase 2/3 Study to Assess Immunogenicity and Safety of Two Different Dose Levels of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Japanese Adult Population Aged 18 to 59 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: H5N1 Influenza
Keywords: Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1)
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Baxter Innovations GmbH
First posted: 2011-06-27
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 to 59 years old at the time of screening
* Subject is generally healthy, as determined by the investigator´s clinical judgement through collection of medical history and performance of a physical examination
* Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
* If female of childbearing potential, subject presents with a negative urine pregnancy test result within 24 hours prior ot the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

* Subject has a history of infectin with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine
* Subject is at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
* Subject 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
* Subject has any inherited or acquired immunodeficiency
* Subject 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
* Subject has a history of severe allergic reactions or anaphylaxis
* Subject has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
* Subject has received a blood transfusion or immunoglobulins within 90 days prior to study entry
* Subject has donated blood or plasma within 30 days prior to study entry
* Subject has received any influenza or any live vaccine within 4 weeks or any other inactivated vaccine within 2 weeks prior to vaccination in this study
* Subject has a functional or surgical asplenia
* Subject has a known or suspected problem with alcohol or drug abuse
* Subject was administered an investigational drug within 6 weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product
* Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator/subinvestigator or site personnel conducting the study
* If female, subject is pregnant or lactating at the time of enrollment
* Subject has any other condition that disqualifies his/her participation in the study in the opinion of the investigator

Primary outcomes:
measure: Number of subjects with antibody response to the vaccine strain
timeFrame: 21 days after 2nd vaccination
measure: Number of subjects demonstrating seroconversion
timeFrame: 21 days after 2nd vaccination
measure: Fold increase of antibody response
timeFrame: 21 days after 2nd vaccination
Secondary outcomes:
measure: Number of subjects with antibody response to the vaccine strain
timeFrame: 21 days after 1st and 21+180 days after 2nd vaccination
measure: Number of subjects demonstrating seroconversion
timeFrame: 21 days after 1st and 21+180 days after 2nd vaccination
measure: Antibody response
timeFrame: 21 days after 1st and 21 + 180 days after 2nd vaccination
measure: Fold increase of antibody response
timeFrame: 21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Medical Co. LTA PS Clinic
state: Fukuoka-Ken
city: Kagoshima-shi
country: Japan
facility: CPC Clinic, Medipolis Medical Research Institute
state: Kagoshima-Ken
city: Osaka-shi
country: Japan
facility: Osaka Pharmacology Clinical Research Hospital
state: Osaka-Fu
Study officials:
affiliation: Baxter Innovations GmbH
name: Alexander Geisberger, MD
role: STUDY_DIRECTOR
References: