Last updated: 11/03/2018 11:46:22
Non-inferiority study of GSK Biologicals' influenza vaccine GSK576389A using different formulations
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Non-inferiority study of GlaxoSmithKline Biologicals' influenza vaccine GSK576389A using different formulations.
Trial description: The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Serum haemagglutination-inhibition (HI) antibody titer against the three vaccine strains
Timeframe: Days 0 and 21
Secondary outcomes:
Number of subjects seropositive for HI antibodies against the three vaccine strains
Timeframe: Days 0 and 21
Number of subjects seroconverted for HI antibodies against the three vaccine strains
Timeframe: Day 21
HI antibody seroconversion factors
Timeframe: Day 21
Number of subjects seroprotected for HI antibodies against the three vaccine strains
Timeframe: Days 0 and 21
Number of subjects reporting any and grade 3 solicited local symptoms
Timeframe: During a 7-day period after vaccination
Duration of solicited local symptoms
Timeframe: During a 7-day period after vaccination
Number of subjects reporting any, grade 3 and related solicited general symptoms
Timeframe: During a 7-day period after vaccination
Duration of solicited general symptoms
Timeframe: During a 7-day period after vaccination
Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs)
Timeframe: During a 21-day period after vaccination
Number of subjects reporting any, grade 3 and related medically significant conditions (MSCs)
Timeframe: During a 21-day period after vaccination
Number of subjects reporting any and related serious adverse events (SAEs)
Timeframe: During the entire study period (up to Day 21)
Interventions:
Biological/vaccine: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)
Biological/vaccine: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
Enrollment:
720
Observational study model:
Not applicable
Primary completion date:
2008-11-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK576389A
Collaborators
Not applicable
Study date(s)
March 2008 to April 2008
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female 65 years of age or older at the time of vaccination.
- Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female 65 years of age or older at the time of vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
Exclusion criteria:
- Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Previous vaccination against influenza with any seasonal vaccine since July 2007.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- 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(s) including egg and chicken protein.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Any medical conditions in which IM injections are contraindicated
Trial location(s)
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-11-04
Actual study completion date
2008-11-04
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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