NCT01382329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 9, 2015

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

June 24, 2011

Last Update Submit

October 7, 2015

Conditions

H5N1 Influenza

Keywords

Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1)

Outcome Measures

Primary Outcomes (3)

  • Number of subjects with antibody response to the vaccine strain

    Measurement by single radial hemolysis (SRH) assay

    21 days after 2nd vaccination

  • Number of subjects demonstrating seroconversion

    Measurement by SRH assay

    21 days after 2nd vaccination

  • Fold increase of antibody response

    Measurement by SRH assay

    21 days after 2nd vaccination

Secondary Outcomes (4)

  • Number of subjects with antibody response to the vaccine strain

    21 days after 1st and 21+180 days after 2nd vaccination

  • Number of subjects demonstrating seroconversion

    21 days after 1st and 21+180 days after 2nd vaccination

  • Antibody response

    21 days after 1st and 21 + 180 days after 2nd vaccination

  • Fold increase of antibody response

    21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline

Study Arms (4)

Treatment group I / Intramuscular

EXPERIMENTAL

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)

Treatment group II / Intramuscular

EXPERIMENTAL

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)

Treatment group III / Subcutaneous

EXPERIMENTAL

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)

Treatment group IV / Subcutaneous

EXPERIMENTAL

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)

Interventions

H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)BIOLOGICAL

Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Treatment group I / IntramuscularTreatment group II / IntramuscularTreatment group III / SubcutaneousTreatment group IV / Subcutaneous

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medical Co. LTA PS Clinic

Fukuoka, Fukuoka, 812-0025, Japan

Location

CPC Clinic, Medipolis Medical Research Institute

Kagoshima, Kagoshima-ken, 890-0081, Japan

Location

Osaka Pharmacology Clinical Research Hospital

Osaka, Osaka, 532-0003, Japan

Location

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

Orthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBird DiseasesAnimal Diseases

Study Officials

  • Alexander Geisberger, MD

    Baxter Innovations GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2011

First Posted

June 27, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2011

Study Completion

May 1, 2012

Last Updated

October 9, 2015

Record last verified: 2012-09

Locations

JP(3)