Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

Phase 2

Completed

• Conditions: Prophylaxis Invasive Pneumococcal Diseases and Pneumonia

• 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.

Study Timeline

• Study Start: 2004-01-20
• Primary Completion: 2005-03-30
• Study Completion: 2005-03-30
• Study First Submitted: 2006-03-06
• Study First Submitted QC: 2006-03-23
• Study First Posted: 2006-03-28
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 concentration	One 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

Name	Time	Method
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).
Anti- PhtD antibody concentration.	At 12, 24 and 36 months after the first vaccination.
Anti-PhtD antibody avidity.	At month 0, 1 and 3.
Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals.	At month 0, 1 and 3.
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 serotypes	At 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 serotypes	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.	At month 0 and month 1.

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇪 Gent, Belgium