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
  Purpose

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.


Condition Intervention Phase
Influenza
Pandemic Influenza
Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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 ]

Enrollment: 408
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Two injections at a 21-day interval (Days 1 and 22)
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.
Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Two injections at a 21-day interval (Days 1 and 22)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959465

Locations
Austria
Sanatorium Leech
Graz, Austria, 8010
University Hospital, Department of Clinical Pharmacology
Vienna, Austria, 1090
Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine
Vienna, Austria, 1090
ClinPharm International GmbH
Vienna, Austria, 1090
Germany
Praxis Regner Schmitt
Mainz, Germany, 55116
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Gerald Aichinger, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Gerald Aichinger, MD; Study Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00959465     History of Changes
Other Study ID Numbers: 820902, EUDRACT Number 2009-013394-17
Study First Received: August 13, 2009
Last Updated: July 8, 2010
Health Authority: Austria: Federal Ministry for Health Family and Youth
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014