A Dose-Finding Study to Assess the Safety, Tolerability, and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (PATH-wSP) in Healthy Kenyan Young Adults and PCV-Primed Toddlers
Abstract
The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV).
Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.
Conditions: Pneumonia, Pneumococcal.
Primary outcome: Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination; Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination; Number/Percent of Adult Subjects Experiencing Headache Following Vaccination; Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination; Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination; Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination; Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination; Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination; Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination; Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination; Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination; Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination;…
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: 304 participants or records.
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