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Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier:
NCT00999206
First received: October 20, 2009
Last updated: August 25, 2011
Last verified: August 2011
History of Changes

October 20, 2009
August 25, 2011
January 2010
August 2010   (final data collection date for primary outcome measure)
Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00999206 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine
Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.

A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: Influenza Vaccine
    surface antigen, inactivated, prepared in cell cultures
  • Biological: Influenza Vaccine
    surface antigen, inactivated, prepared in egg (influvac ®)
  • Experimental: 1
    Intervention: Biological: Influenza Vaccine
  • Experimental: 2
    Intervention: Biological: Influenza Vaccine
  • Experimental: 3
    Intervention: Biological: Influenza Vaccine
  • Active Comparator: 4
    Intervention: Biological: Influenza Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3138
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age).
  2. Willing and able to give informed consent before any protocol procedures are performed.
  3. Able to adhere to visit schedules and all protocol required study procedures.
  4. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).

Exclusion Criteria

  1. Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
  2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
  3. A serious adverse reaction after a previous (influenza) vaccination.
  4. A history of Guillain-Barré syndrome.
  5. Known to be allergic to constituents of the study vaccines.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
 
NCT00999206
S203.3.013
No
Abbott ( Abbott Biologicals )
Abbott Biologicals
Quintiles
Study Director: Hanka de Voogd, MD Abbott Healthcare Products B.V.
Abbott
August 2011

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