At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 42 enrolled
Drug / intervention
SPWCV+Alum 100 mcg +3 morebiological
Likely dose
SPWCV+Alum 100 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Randomized, Double-Blind, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (SPWCV+Alum) in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating Placebo, SPWCV+Alum 100 mcg, and 2 other interventions for Pneumococcal Vaccines. Completed, enrolled 42 participants across 1 site.
Detailed Summary
The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Vaccines
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedFeb 2012
Primary CompletionOct 2012
Study CompletionApr 2013
TodayJul 2026
First PostedFeb 23, 2012
Enrollment StartFeb 1, 2012
Primary CompletionOct 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.4 years ago
Interventions
Placeboother
3 cohorts of normal saline injection
SPWCV+Alum 100 mcgbiological
3 injections 28 days apart
SPWCV+Alum 600 mcgbiological
3 injections 28 days apart
SPWCV+Alum 300 mcgbiological
3 injections 28 days apart