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Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults

NCT00895544 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2015-10-09

No results posted yet for this study

Summary

The main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule.

Conditions

Interventions

BIOLOGICAL

Influenza vaccine (whole virion, Vero cell derived)

Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose B (Indonesia strain) for booster vaccination (Day 360)

BIOLOGICAL

Influenza vaccine (whole virion, Vero cell derived)

Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose A (Indonesia strain) for booster vaccination (Day 360)

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Gerald Aichinger, MD · Baxter Healthcare Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-10-31
Completion
2011-06-30

Countries

  • Austria
  • Finland

Study Locations

More Related Trials

Entities

Diseases

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 NCT00895544 on ClinicalTrials.gov