NCT01444339

Study of Two Investigational Pneumococcal Vaccines in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the safety, tolerability, and immunogenicity of two investigational pneumococcal vaccines at three dose levels in healthy adults. Primary Objective: \- To evaluate the safety and tolerability of two investigational pneumococcal vaccines. Observational Objective: \- To evaluate the immunogenicity of the investigational pneumococcal vaccines.

Detailed description

An initial cohort of 6 participants will receive a single dose of one of two investigational pneumococcal vaccines. After safety evaluation of that cohort, additional cohorts will receive 2 injections 30 days apart of same investigational pneumococcal vaccine at same or increased dose level. All participants will be monitored for safety for 30 days after each vaccination.

Conditions

• Pneumococcal Infections
• Streptococcus Pneumoniae Infections
• Pneumococcal Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal Vaccine Formulation 1	0.5 mL, intramuscular (1 middle dose)
BIOLOGICAL	Pneumococcal Vaccine Formulation 2	0.5 mL, intramuscular (2 low doses)
BIOLOGICAL	Pneumococcal Vaccine Formulation 3	0.5 mL, intramuscular (2 middle doses)
BIOLOGICAL	Pneumococcal Vaccine Formulation 4	0.5 mL, intramuscular (2 middle doses)
BIOLOGICAL	Pneumococcal Vaccine Formulation 5	0.5 mL, intramuscular (2 high doses)
BIOLOGICAL	Placebo	0.5 mL, intramuscular

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2011-09-30
• Last updated: 2011-09-30

Locations

1 site across 1 country: Switzerland