Last updated: 11/03/2018 10:03:41
Study to evaluate the immunogenicity and safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A low dose influenza vaccine candidate
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A study to evaluate the immunogenicity, safety and reactogenicity of adjuvanted influenza vaccine candidates compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years.
Trial description: The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Titers of serum haemagglutination-inhibition (HI) antibodies against each of the 3 influenza strains assessed.
Timeframe: At Day 0 and at Day 21.
Number of seroprotected subjects against each of the 3 influenza strains assessed.
Timeframe: At Day 0 and at Day 21.
Number of seroconverted subjects against each of the 3 influenza strains assessed
Timeframe: At Day 21.
Seroconversion factor against each of the 3 Influenza strains assessed.
Timeframe: At Day 21.
Secondary outcomes:
Number of subjects with any and grade 3 solicited local symptoms
Timeframe: Within the 7-day follow-up period (Days 0-6) after vaccination
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: Within the 7-day follow-up period (Days 0-6) after vaccination
Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)
Timeframe: Within the 30-day follow-up period (Days 0-29) after vaccination
Number of subjects with any and related serious adverse events (SAEs)
Timeframe: From study start to study end, from Day 0 to Day 30
Interventions:
Biological/vaccine: Fluarix™
Biological/vaccine: GSK1247446A
Enrollment:
300
Observational study model:
Not applicable
Primary completion date:
2006-30-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK1247446A
Collaborators
Not applicable
Study date(s)
October 2006 to November 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 59 years
Accepts healthy volunteers
Yes
- A male or female aged 18-59 years at the time of the first vaccination.
- Free of obvious health problems
- Use of non-registered products
- Administration of immune-modifying drugs.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female aged 18-59 years at the time of the first vaccination.
- Free of obvious health problems
Exclusion criteria:
- Use of non-registered products
- Administration of immune-modifying drugs.
- Administration of vaccine 30 days before enrolment in study.
- Immunosuppressive or immunodeficient condition.
- Hypersensitivity to a previous dose of influenza vaccine
- Previous vaccination against influenza in 2006
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- History of confirmed influenza infection within the last 12 Months.
- Acute disease at the time of enrolment/vaccination.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine
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
2006-30-11
Actual study completion date
2006-30-11
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.
Additional information about the trial
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