Last updated: 11/03/2018 11:06:38
Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Non-Inferiority of GlaxoSmithKline Biologicals' Influenza Vaccine (GSK576389A) 1 Container Over 2 Container Presentation in Adults Aged 65 Years and Over
Trial description: This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Haemagglutination Inhibition (HI) antibody titers for the H1N1 vaccine strain
Timeframe: At Days 0 and 21
Secondary outcomes:
HI antibody titers against each of the three vaccine strains for the two season formulations
Timeframe: At Days 0 and 21
The number of subjects seroconverted for HI antibodies against each of the three vaccine strains for the two season formulations
Timeframe: At Day 21
HI antibody seroconversion factors
Timeframe: At Day 21
The number of subjects seroprotected for HI antibodies against each of the three vaccine strains for the two season formulations
Timeframe: At Days 0 and 21
Number of subjects reporting any and grade 3 solicited local Adverse Events (AEs)
Timeframe: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of solicited local AEs
Timeframe: During a 7-day follow-up period (Day 0-6) after vaccination
Number of subjects reporting any, grade 3 and related solicited general AEs
Timeframe: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of solicited general AEs
Timeframe: During a 7-day follow-up period (Day 0-6) after vaccination
Number of subjects reporting any, grade 3 and related unsolicited AEs
Timeframe: During a 21-day follow-up period (Day 0-20) after vaccination
Number of subjects reporting any, grade 3 and related medically significant conditions (MSCs)
Timeframe: During a 21-day follow-up period (Day 0-20) after vaccination
Number of subjects reporting any and related serious adverse events (SAEs)
Timeframe: During a 21-day follow-up period (Day 0-20) after vaccination
Interventions:
Biological/vaccine: GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]
Biological/vaccine: GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]
Biological/vaccine: Fluarix [NH 2006/07 season]
Biological/vaccine: Fluarix [NH 2007/08 season]
Enrollment:
1596
Observational study model:
Not applicable
Primary completion date:
2007-02-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK576389A
Collaborators
Not applicable
Study date(s)
September 2007 to November 2007
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 aged 65 years or older at the time of the vaccination.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, 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 Visit 2 after vaccination.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female aged 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- 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 Visit 2 after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation 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 administration of the study vaccine or planned administration during the study.
- Any medical conditions in which intramuscular injections are contraindicated.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
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
2007-02-11
Actual study completion date
2007-02-11
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.
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