Last updated: 11/07/2018 02:09:43
A study to demonstrate the efficacy of GSK Biologicals’ influenza vaccine in adults
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A study to demonstrate the efficacy of GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly in adults
Trial description: The purpose of this study is to demonstrate the efficacy of GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly in adults.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Fluarix vaccine
Enrollment:
7632
Observational study model:
Not applicable
Primary completion date:
2007-07-06
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) Efficacy of inactivated split-virus influenza vaccine against culture-confirmed influenza in healthy adults: a prospective, randomized, placebo-controlled trial. J Infect Dis. 200(12): 1861-1869.
Vesikari T et al. (2012) Use of real-time polymerase chain reaction (rtPCR) as a diagnostic tool for influenza infection in a vaccine efficacy trial. J Clin Virol. 53(1):22-28.
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
September 2006 to June 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
Yes
- A male or female age between 18 and 64 years at the time of the first vaccination.
- non-childbearing female
- Use of non-registered products
- Pregnancy
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female age between 18 and 64 years at the time of the first vaccination.
- non-childbearing female
Exclusion criteria:
- Use of non-registered products
- Pregnancy
- Hypersensitivity to a previous dose of influenza vaccine
- Acute disease at the time of enrolment/vaccination.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine
- Administration of any other influenza vaccine for the season 2006-2007
- Chronic disorders of the pulmonary or cardiovascular system, including asthma.
- Administration of immune-modifying drugs
- Administration of immunoglobulins and/or any blood products
- History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)
Trial location(s)
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 03
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
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
2007-07-06
Actual study completion date
2007-07-06
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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Additional information
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