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H5N1 Vaccine Study in Japanese Adults

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ClinicalTrials.gov Identifier: NCT01382329
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : October 9, 2015
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Ology Bioservices

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.

Condition or disease Intervention/treatment Phase
H5N1 Influenza Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : June 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group I / Intramuscular
85 subjects to receive 2 intramuscular vaccinations at Dose A on Days 1 and 22
Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)
Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Experimental: Treatment group II / Intramuscular
85 subjects to receive 2 intramuscular vaccinations at Dose B on Days 1 and 22
Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)
Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Experimental: Treatment group III / Subcutaneous
85 subjects to receive 2 subcutaneous vaccinations at Dose A on Days 1 and 22
Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)
Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Experimental: Treatment group IV / Subcutaneous
85 subjects to receive 2 subcutaneous vaccinations at Dose B on Days 1 and 22
Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)
Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm




Primary Outcome Measures :
  1. Number of subjects with antibody response to the vaccine strain [ Time Frame: 21 days after 2nd vaccination ]
    Measurement by single radial hemolysis (SRH) assay

  2. Number of subjects demonstrating seroconversion [ Time Frame: 21 days after 2nd vaccination ]
    Measurement by SRH assay

  3. Fold increase of antibody response [ Time Frame: 21 days after 2nd vaccination ]
    Measurement by SRH assay


Secondary Outcome Measures :
  1. Number of subjects with antibody response to the vaccine strain [ Time Frame: 21 days after 1st and 21+180 days after 2nd vaccination ]
    Measurement by SRH (except at 21 days after 2nd vaccination), microneutralization (MN) and hemagglutination inhibition (HI) assay

  2. Number of subjects demonstrating seroconversion [ Time Frame: 21 days after 1st and 21+180 days after 2nd vaccination ]
    Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay

  3. Antibody response [ Time Frame: 21 days after 1st and 21 + 180 days after 2nd vaccination ]
    Measurement by SRH, MN and HI assay

  4. Fold increase of antibody response [ Time Frame: 21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline ]
    Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382329


Locations
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Japan
Medical Co. LTA PS Clinic
Fukuoka-shi, Fukuoka-Ken, Japan, 812-0025
CPC Clinic, Medipolis Medical Research Institute
Kagoshima-shi, Kagoshima-Ken, Japan, 890-0081
Osaka Pharmacology Clinical Research Hospital
Osaka-shi, Osaka-Fu, Japan, 532-0003
Sponsors and Collaborators
Ology Bioservices
Baxter Innovations GmbH
Investigators
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Study Director: Alexander Geisberger, MD Baxter Innovations GmbH

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Responsible Party: Ology Bioservices
ClinicalTrials.gov Identifier: NCT01382329     History of Changes
Other Study ID Numbers: 811001
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: September 2012
Keywords provided by Ology Bioservices:
Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1)
Additional relevant MeSH terms:
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Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs