Sponsor study identifier
Secondary identifiers
interventional
408
2 countries
5
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2009
Actual (reported)Study Completion
April 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
August 13, 2009
Actual (reported)August 14, 2009
Actual (reported)November 2009
Actual (reported)April 2010
Actual (reported)Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination
42 days
Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.
Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.
Two injections at a 21-day interval (Days 1 and 22)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sanatorium Leech
Graz, 8010, Austria
ClinPharm International GmbH
Vienna, 1090, Austria
Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine
Vienna, 1090, Austria
University Hospital, Department of Clinical Pharmacology
Vienna, 1090, Austria
Praxis Regner Schmitt
Mainz, 55116, Germany
Gerald Aichinger, MD
Baxter Healthcare Corporation
408 participants (actual enrollment reported by the registry).
First Submitted
August 13, 2009
First Posted
August 14, 2009
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
Reverse Genetic H9N2 Influenza Vaccine Study in Adults
A second cohort may be enrolled with all subjects in this cohort receiving two vaccinations of Dose C of H1N1 pandemic influenza vaccine at a 21-day interval.
Contact the study team to confirm eligibility.
Primary Completion
November 2009
Actual (reported)Study Completion
April 2010
Actual (reported)Last Updated
October 9, 2015
Record last verified: 2010-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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