A/H1N1 Immunogenicity and Safety in Adults

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00959465
First received: August 13, 2009
Last updated: July 8, 2010
Last verified: July 2010

August 13, 2009
July 8, 2010
August 2009
November 2009   (final data collection date for primary outcome measure)
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 [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00959465 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A/H1N1 Immunogenicity and Safety in Adults
An Open Label Phase 1/2 Study to Assess Immunogenicity and Safety of Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Adults Aged 18 Years and Older

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Influenza
  • Pandemic Influenza
Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Two injections at a 21-day interval (Days 1 and 22)
  • Experimental: Cohort 1/Dose Level A
    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.
    Intervention: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
  • Experimental: Cohort 1/Dose B
    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.
    Intervention: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
  • Experimental: Cohort 2/Dose C
    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.
    Intervention: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
408
April 2010
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is 18 to 59 years old (age stratum A) or 60 years of age or older (age stratum B) at the time of screening
  • Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
  • Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the 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 has a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

  • Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
  • Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen
  • Subject has inherited or acquired immune deficiency
  • Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00959465
820902, EUDRACT Number 2009-013394-17
Yes
Gerald Aichinger, MD; Study Medical Director, Baxter Healthcare Corporation
Baxter Healthcare Corporation
Not Provided
Study Director: Gerald Aichinger, MD Baxter Healthcare Corporation
Baxter Healthcare Corporation
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP