NCT01444001

Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers. Primary Objective: * To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.

Detailed description

Each volunteer participant will receive two injections with one of three vaccine doses, administered on Day 0 and Day 30, in a dose-ascending manner, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each injection.

Conditions

• Pneumococcal Infections
• Pneumococcal Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal Vaccine	0.5 mL, intramuscular
BIOLOGICAL	Pneumococcal Vaccine	0.5 mL, intramuscular
BIOLOGICAL	Pneumococcal Vaccine	0.5 mL, intramuscular

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2011-09-30
• Last updated: 2011-09-30

Locations

1 site across 1 country: Switzerland