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H5N1 Vaccine Study in Japanese Adults

NCT01382329 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2015-10-09

No results posted yet for this study

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.

Conditions

  • H5N1 Influenza

Interventions

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

Sponsors & Collaborators

  • Baxter Innovations GmbH

    collaborator INDUSTRY

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexander Geisberger, MD · Baxter Innovations GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-08-31
Completion
2012-05-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382329 on ClinicalTrials.gov