Last updated: 11/03/2018 10:06:13
Study to evaluate the immunogenicity and safety of a second vaccination with the adjuvanted influenza vaccine candidate
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study to evaluate the immunogenicity, safety and reactogenicity of a second vaccination with the adjuvanted influenza vaccine candidate compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above.
Trial description: The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with any and grade 3 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)
Secondary outcomes:
Titers for serum Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease.
Timeframe: At Day 0 and Day 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
Interventions:
Enrollment:
678
Primary completion date:
2007-05-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK1247446A
Collaborators
Not applicable
Study date(s)
October 2006 to February 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
Yes
- A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials.
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials.
Exclusion criteria:
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration 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 30 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of confirmed influenza infection within the last 12 months.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute disease at the time of enrolment.
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, 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
Study complete
Actual primary completion date
2007-05-02
Actual study completion date
2007-05-02
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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