Yearly Strain Variation Study, 2009/2010

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00943657
First received: July 21, 2009
Last updated: October 6, 2009
Last verified: October 2009

July 21, 2009
October 6, 2009
June 2009
July 2009   (final data collection date for primary outcome measure)
Number of subjects demonstrating seroconversion to each of the three antigens contained in the vaccine 21 days after vaccination [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00943657 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Yearly Strain Variation Study, 2009/2010
An Open-Label Phase 3 Study to Assess the Immunogenicity and Safety of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult and Elderly Population

The purpose of this study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to World Heath Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly licensing application.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Influenza
  • Seasonal Influenza
Biological: Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]
Single intramuscular injection of vaccine
Other Name: Preflucel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is 18 to 59 years of age , inclusive, at the time of screening (for subjects in age stratum A only)
  • Subject is 60 years of age or older , inclusive, at the time of screening (for subjects in age stratum B only)
  • Subject has given 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 performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
  • Subject agrees to keep a daily record of symptoms for the duration of the study
  • If female of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
  • Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

  • Subject has a history of severe allergic reaction or anaphylaxis
  • Subject has an oral temperature of >= 37.5°C on the day of vaccination in this study
  • Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating
  • Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
  • Subject has received a seasonal influenza vaccine within 6 months of study entry
  • Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
  • Subject has any inherited or acquired immunodeficiency
  • Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
  • Subject has a functional or surgical asplenia
  • Subject has a known or suspected problem with alcohol or drug abuse
  • Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
  • If female, subject is pregnant or lactating at the time of study enrollment
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00943657
720901
No
Gerald Aichinger, MD; Study Medical Director, Baxter Healthcare Corporation
Baxter Healthcare Corporation
Not Provided
Not Provided
Baxter Healthcare Corporation
October 2009

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