A/H1N1 Immunogenicity and Safety in Adults

NCT00959465 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2015-10-09

No results posted yet for this study

Summary

The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.

Conditions

Interventions

BIOLOGICAL

H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

Two injections at a 21-day interval (Days 1 and 22)

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
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-11-30
Completion
2010-04-30

Countries

  • Austria
  • Germany

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 NCT00959465 on ClinicalTrials.gov