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
Abstract
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.
Conditions: Prophylaxis Invasive Pneumococcal Diseases and Pneumonia.
Primary outcome: Occurrence, intensity and relationship of any solicited local and general signs and symptoms.; Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms.; Occurrence of all serious adverse events (SAE).; Anti- PhtD antibody concentration; Anti-PhtD antibody concentration..
Enrollment: 146 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 146 participants or records.
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