Last updated: 11/03/2018 09:33:12
Study to demonstrate the lot-to-lot consistency and to evaluate the safety of an adjuvanted influenza vaccine candidate
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Demonstrate the lot-to-lot consistency of 3 consecutive production lots of an adjuvanted influenza vaccine candidate and evaluate the safety of an adjuvanted influenza vaccine candidate versus Fluarix™ administered intramuscularly in elderly
Trial description: The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
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 Days 0 and 21
Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease.
Timeframe: At Day 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 new onset of chronic diseases (NOCDs).
Timeframe: From Day 0 to Day 180
Number of subjects with medically significant conditions (MSCs).
Timeframe: From Day 0 to Day 180
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 (Days 0-180)
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
3124
Primary completion date:
2006-07-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK1247446A
Collaborators
Not applicable
Study date(s)
April 2006 to July 2006
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 vaccination.
- 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 vaccination.
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 three 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)
Location
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG2 7AG
Status
Study Complete
Showing 1 - 6 of 46 Results
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
2006-07-07
Actual study completion date
2006-07-07
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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