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Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

Phase 2
Completed
Conditions
Prophylaxis Invasive Pneumococcal Diseases and Pneumonia
Interventions
Biological: Pneumococcal vaccine GSK513026
Biological: Pneumovax 23™
Registration Number
NCT00307528
Lead Sponsor
GlaxoSmithKline
Brief Summary

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.

Detailed Description

Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge during the study period (for 3 consecutive years starting from September 2004), to be used by Investigators according to national vaccination schedule/practice.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
146
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group EPneumococcal vaccine GSK513026-
Group BPneumococcal vaccine GSK513026-
Group CPneumococcal vaccine GSK513026-
Group DPneumococcal vaccine GSK513026-
Group APneumovax 23™-
Group FPneumococcal vaccine GSK513026-
Primary Outcome Measures
NameTimeMethod
Occurrence, intensity and relationship of any solicited local and general signs and symptoms.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.During a 30-day follow up period after each vaccine dose.
Anti- PhtD antibody concentrationOne month after the first injection
Occurrence of all serious adverse events (SAE).During the entire study period.
Anti-PhtD antibody concentration.One month after 2 injections
Secondary Outcome Measures
NameTimeMethod
Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals.At month 0, 1 and 3.
Anti- PhtD antibody concentration.At 12, 24 and 36 months after the first vaccination.
Anti-PhtD antibody avidity.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.At month 0, 1, 3, 12.
Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis.At each scheduled time point (month 0, 1, 3, 12, 24 and 36).
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.At month 0, 1, 3, 12.
Anti-polysaccharide total IgG concentration in Group A for all vaccine pneumococcal serotypesAt month 0, 1, 12, 24 and 36.
Anti-PS antibody avidity for 5 serotypes in Group A.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.At month 0 and 1.
Opsonophagocytic activity titres in Group A to all vaccine pneumococcal serotypesAt 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.At month 0 and month 1.

Trial Locations

Locations (1)

GSK Investigational Site

🇧🇪

Gent, Belgium

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