Last updated: 10/29/2019 12:10:55
Safety and efficacy study of investigational pneumococcal vaccine in Elderly population
GSK study ID
100409
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Study to Evaluate the Safety, Reactogenicity & Immunogenicity of the GSK Biologicals Candidate Pneumococcal Vaccine Without or With Adjuvant, Administered at 2 Different Concentrations, in Healthy Elderly Subjects
Trial description: As the licensed Pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the safety and the immune response of the new investigational pneumococcal protein vaccine is evaluated in healthy elderly population.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Occurrence, intensity and relationship of any solicited local and general signs and symptoms.
Timeframe: During a 7-day follow up period after each vaccine dose.
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms.
Timeframe: During a 30-day follow up period after each vaccine dose.
Occurrence of all serious adverse events (SAE).
Timeframe: During the entire study period.
Anti- PhtD antibody concentration
Timeframe: One month after the first injection
Anti-PhtD antibody concentration.
Timeframe: One month after 2 injections
Secondary outcomes:
Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis.
Timeframe: At each scheduled time point (month 0, 1, 3, 12, 24 and 36).
Anti- PhtD antibody concentration.
Timeframe: At 12, 24 and 36 months after the first vaccination.
Anti-PhtD antibody avidity.
Timeframe: At month 0, 1 and 3.
Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals.
Timeframe: At month 0, 1 and 3.
Frequency of PhtD specific plasma cells generated by in vitro cultivated memory B-cells, in a subset of subjects.
Timeframe: At month 0, 1, 3, 12.
Frequency of CD4 and/or CD8 T cells that produce cytokines (IL-2, IL-4, IFNg, CD40L and/or GM-CSF, and TNFα), upon PhtD re-stimulation in vitro, to evaluate the T-cell response, in a subset of subjects.
Timeframe: At month 0, 1, 3, 12.
Anti-polysaccharide total IgG concentration in Group A for all vaccine pneumococcal serotypes
Timeframe: At month 0, 1, 12, 24 and 36.
Anti-PS antibody avidity for 5 serotypes in Group A.
Timeframe: At month 0 and 1.
Deposition of complement components on the surface of different bacterial strains 3 strains (GSK/CDC, OPA, isogenic TIGR4) of 5 serotypes in Group A.
Timeframe: At month 0 and 1.
Opsonophagocytic activity titres in Group A to all vaccine pneumococcal serotypes
Timeframe: At month 0, 1 and 12.
Frequency of PS-specific plasma cells generated by in vitro cultivated memory B-cells in Group A in a subset of subjects.
Timeframe: At month 0 and month 1.
Interventions:
Biological/vaccine: Pneumococcal vaccine GSK513026
Biological/vaccine: Pneumovax 23™
Enrollment:
146
Observational study model:
Not applicable
Primary completion date:
2005-30-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Prophylaxis Invasive pneumococcal diseases and pneumonia
Product
SB513026
Collaborators
Not applicable
Study date(s)
January 2004 to March 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
Yes
- Inclusion criteria
- Subjects who the investigator believes will comply with the requirements of the protocol
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria -Subjects who the investigator believes will comply with the requirements of the protocol -A male or female ≥ 65 years at the time of the first vaccination. -Written informed consent obtained from the subject. -Free of obvious health problems as established by medical history and clinical examination before entering into the study. Exclusion criteria -Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study. -Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. -Use of any anticoagulants. -Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines. -Previous vaccination against Streptococcus pneumoniae. -Bacterial pneumonia within 3 years prior to 1st vaccination. -Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. -History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. -Current serious neurologic or mental disorders. -Currently smoking > 25 cigarettes per day. -Inflammatory processes such as known chronic active infections -All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years. -History of administration of an experimental vaccine containing MPL or QS21. -Acute disease at the time of enrolment. -Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator. -History of chronic alcohol consumption and/or intravenous drug abuse.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2005-30-03
Actual study completion date
2005-30-03
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
Additional information
Not applicable
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