Last updated: 02/13/2019 07:44:27
Evaluate safety & immunogenicity of a pandemic influenza vaccine (GSK1562902A) in adults over 60 years of age
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluate immunogenicity & safety of a single or double-dose of the pandemic influenza candidate vaccine (GSK1562902A) given following a two-administration schedule (21 days apart) in adults over 60 yrs
Trial description: The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of influenza antibodies will also be evaluated 24 months after vaccination.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Titers for serum Hemagglutination Inhibition (HI) antibodies against two strains of influenza disease.
Timeframe: At Days 0, 21 and 42
Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease.
Timeframe: At Days 21 and 42
Number of seroprotected subjects against 2 strains of influenza disease
Timeframe: At Days 0, 21 and 42
Neutralizing antibody titers for serum Hemagglutination Inhibition (HI) antibodies against two strains of influenza disease.
Timeframe: At Days 0 and 42
Number of seroconverted subjects against 2 strains of influenza disease.
Timeframe: At Days 21 and 42
Number of seroconverted subjects for neutralizing antibody response against 2 strains of influenza disease.
Timeframe: At Day 42
Titers for serum Hemagglutination Inhibition (HI) antibodies against two strains of influenza disease.
Timeframe: At Day 180
Titers for serum Hemagglutination Inhibition (HI) antibodies against two strains of influenza disease.
Timeframe: At Month 12
Titers for serum Hemagglutination Inhibition (HI) antibodies against two strains of influenza disease.
Timeframe: At Month 24
Number of seroconverted subjects against 2 strains of influenza disease.
Timeframe: At Day 180
Number of seroconverted subjects against 2 strains of influenza disease.
Timeframe: At Month 12
Number of seroconverted subjects against 2 strains of influenza disease.
Timeframe: At Month 24
Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease.
Timeframe: At Day 180
Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease
Timeframe: At Month 12
Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease
Timeframe: At Month 24
Number of seroprotected subjects against 2 strains of influenza disease
Timeframe: At Day 180
Number of seroprotected subjects against 2 strains of influenza disease
Timeframe: At Month 12
Number of seroprotected subjects against 2 strains of influenza disease
Timeframe: At Month 24
Number of seroconverted subjects for neutralizing antibody response against 2 strains of influenza disease.
Timeframe: At Day 180
Number of seroconverted subjects for neutralizing antibody response against 2 strains of influenza disease.
Timeframe: At Month 12
Number of seroconverted subjects for neutralizing antibody response against 2 strains of influenza disease.
Timeframe: At Month 24
Neutralizing antibody titers for serum Hemagglutination Inhibition (HI) antibodies against two strains of influenza disease.
Timeframe: At Month 12
Neutralizing antibody titers for serum Hemagglutination Inhibition (HI) antibodies against two strains of influenza disease.
Timeframe: At Month 24
Neutralizing antibody titers for serum Hemagglutination Inhibition (HI) antibodies against two strains of influenza disease.
Timeframe: At Day 180
Secondary outcomes:
Number of subjects with adverse events of specific interest (AESIs)
Timeframe: During the entire study period (Day 0 to Month 24)
Number of subjects with any and grade 3 solicited local symptoms.
Timeframe: During the 7-day follow-up period (Days 0 to 6) after any vaccination
Number of subjects with abnormalities in assessed biochemical and hematological laboratory parameters.
Timeframe: At Days 0, 2, 21 and 23
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (Day 0 to Month 24).
Number of subjects with any, grade 3 and related unsolicited adverse events (AEs).
Timeframe: During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination
Number of subjects with abnormalities in assessed biochemical and hematological laboratory parameters.
Timeframe: At Days 0, 2, 21 and 23.
Geometric mean of influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
Timeframe: At Month 12
Geometric mean of influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
Timeframe: At Month 24
Number of subjects with abnormalities in assessed biochemical and hematological laboratory parameters.
Timeframe: At Days 0, 2, 21 and 23.
Geometric mean of influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
Timeframe: At Days 0, 21 and 42
Geometric mean of influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells
Timeframe: At Day 180
Number of subjects with any, grade 3 and related solicited general symptoms.
Timeframe: During the 7-day follow-up period (Days 0 to 6) after any vaccination
Interventions:
Biological/vaccine: Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not)
Biological/vaccine: Fluarix
Enrollment:
437
Observational study model:
Not applicable
Primary completion date:
2009-14-09
Time perspective:
Not applicable
Clinical publications:
Gillard P et al. (2014) Long-term outcome of the humoral and cellular immune response of an H5N1 adjuvanted influenza vaccine in elderly persons: 2-year follow-up of a randomised open-label study. Trials. 15(1):419.
Heijmans S et al. (2011) Immunogenicity profile of a 3.75-?g hemagglutinin pandemic rH5N1 split virion AS03A-adjuvanted vaccine in elderly persons: a randomized trial. J Infect Dis. 203(8):1054-1062.
Medical condition
Influenza
Product
GSK1562902A
Collaborators
Not applicable
Study date(s)
November 2006 to September 2009
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 will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 61 years or above at the time of the first vaccination.
- Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
- Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female aged 61 years or above at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects or subjects with well controlled underlying disease.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- Administration of 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 the second vaccination with H5N1 vaccine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of chronic alcohol consumption and/or drug abuse.
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy).
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease at the time of enrolment.
- Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
Trial location(s)
Location
GSK Investigational Site
Monserrato Cagliari, Sardegna, Italy, 09042
Status
Study Complete
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
2009-14-09
Actual study completion date
2009-14-09
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.
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