Last updated: 11/03/2018 09:22:53
Study to Evaluate an Influenza Vaccine Candidate
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Study to Demonstrate the Non-Inferiority of Influenza Vaccine Candidate, Compared With Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years Old and Above
Trial description: The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old 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 virus
Timeframe: At Days 0 and 21 post-vaccination
Secondary outcomes:
Titers for serum Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza virus
Timeframe: At Day 180 post-vaccination.
Number of subjects with any and grade 3 solicited local symptoms.
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination
Number of subjects with any, grade 3 and related solicited general symptoms.
Timeframe: During the 7-day (Days 0-6) follow up period after vaccination
Number of subjects with unsolicited adverse events (AEs).
Timeframe: During the 30-day (Days 0-29) follow-up period after vaccination
Number of subjects with any and related serious adverse events (SAEs)
Timeframe: During the entire study period (Day 0 to Day 180)
Interventions:
Enrollment:
1220
Primary completion date:
2006-18-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK1247446A
Collaborators
Not applicable
Study date(s)
May 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 hypersensivity to a previous dose of influenza vaccine.
- Previous vaccination against influenza within the 9 months prior to enrollment.
- 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)
Showing 1 - 6 of 17 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
2006-18-07
Actual study completion date
2006-18-07
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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