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Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults

NCT01537185 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-06-05

Study results available
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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.

Conditions

  • Pneumococcal Vaccines

Interventions

OTHER

Placebo

3 cohorts of normal saline injection

BIOLOGICAL

SPWCV+Alum 100 mcg

3 injections 28 days apart

BIOLOGICAL

SPWCV+Alum 600 mcg

3 injections 28 days apart

BIOLOGICAL

SPWCV+Alum 300 mcg

3 injections 28 days apart

Sponsors & Collaborators

  • PATH Vaccine Solutions

    lead OTHER

Principal Investigators

  • Royce Morrison, M.D. · Comprehensive Clinical Development

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-10-31
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01537185 on ClinicalTrials.gov