Last updated: 11/03/2018 00:37:14

Post-marketing study to evaluate the efficacy of influenza vaccine

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GSK study ID
104438
See study documents
Clinicaltrials.gov ID
NCT00197223
EudraCT ID
2005-002044-26
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized, double-blind, placebo-controlled, post-marketing phase III Study to evaluate the efficacy of GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly in adults.
Trial description: As a result of the recent supply shortages in the U.S., as well as an anticipated increase in demand during the coming years, GSK Biologicals is pursuing licensure of Fluarix in the U.S. under the accelerated approval process; marketing approval most likely will be granted before the start of this clinical trial. GSK proposes to support U.S. licensure of Fluarix with this confirmatory post-marketing study. The purpose of the study is to evaluate the efficacy of a single dose of Fluarix in preventing influenza in adults during the 2005/2006 Influenza season.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Influenza vaccine
Enrollment:
6213
Observational study model:
Not applicable
Primary completion date:
2005-26-10
Time perspective:
Not applicable
Clinical publications:
Benoit A et al. (2015) Hemagglutination inhibition antibody titers as a correlate of protection against seasonal A/H3N2 influenza disease. Open Forum Infectious Diseases. 2(2).
Beran J et al. (2009) Challenge of conducting an efficacy study for Influenza vaccine in a year with low attack rate and a drifted B strain: A concrete example. BMC Infectious Diseases. 9(2):doi:10.1186/1471-2334-9-2.
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
September 2005 to May 2006
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
Yes
  • A male or female age between, and including, 18 and 64 years of age at the time of the vaccination.
  • Written informed consent obtained from the subject.
  • History of hypersensitivity to a previous dose of influenza vaccine.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate.
Inclusion and exclusion criteria
Inclusion criteria:

    A male or female age between, and including, 18 and 64 years of age at the time of the vaccination.

    • Written informed consent obtained from the subject.
    • Availability to follow up by phone during the study period.
    • Female subjects must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal. If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after vaccination.
Exclusion criteria:

    History of hypersensitivity to a previous dose of influenza vaccine.

    • History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate.
    • Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature < 37.5°C).
    • Pregnancy
    • Chronic disorders of the pulmonary or cardiovascular system, including asthma
    • History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 03
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
2005-26-10
Actual study completion date
2006-31-05

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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