Last updated: 11/03/2018 09:51:12
Study to evaluate the immunogenicity and the safety of an adjuvanted 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 candidate compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly aged 60 years and older.
Trial description: The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Titers for serum Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease.
Timeframe: At Days 0 and 21
Number of seroconverted subjects against 3 strains of influenza disease.
Timeframe: At Day 21
Number of seroprotected subjects against 3 strains of influenza disease.
Timeframe: At Day 0 and Day 21
Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease.
Timeframe: At Day 21
Secondary outcomes:
Geometric mean of influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Timeframe: At Days 0 and 21
Geometric mean of influenza-specific Cluster of Differentiation (CD) 8 T-cells.
Timeframe: At Days 0 and 21
Number of subjects with any, grade 3 and related solicited local symptoms.
Timeframe: During the 7-day (Days 0-6) post-vaccination period
Number of subjects with any, grade 3 and related solicited general symptoms.
Timeframe: During the 7-day (Days 0-6) post-vaccination period
Number of subjects with any, grade 3 and related unsolicited adverse events (AEs).
Timeframe: During the 30-day (Days 0-29) post vaccination period
Number of subjects with any and related serious adverse events (SAEs).
Timeframe: During the entire study period (from Day 0 to Day 29)
Interventions:
Biological/vaccine: GSK1247446A Group
Biological/vaccine: Fluarix™
Enrollment:
150
Observational study model:
Not applicable
Primary completion date:
2006-17-11
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
60+ years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
- A male or female 60 years or older at the time of the first vaccination.
- Use of non-registered products
- Administration of immune-modifying drugs.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
- A male or female 60 years or older 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
- Acute 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
2006-17-11
Actual study completion date
2006-17-11
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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