NCT01444352

Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

An initial cohort of 10 participants will receive a single dose of investigational pneumococcal vaccine. After safety assessment of this cohort during a 24-hour in-unit observation period, additional cohorts will receive two injections of the study vaccine 30 days apart, at three dose levels, in ascending doses by cohort, pending safety review at each 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 (Low dose)
BIOLOGICAL	Pneumococcal vaccine Formulation 2	0.5 mL, Intramuscular (Middle dose)
BIOLOGICAL	Pneumococcal vaccine Formulation 3	0.5 mL, Intramuscular (High dose)
BIOLOGICAL	Placebo	0.5 mL, Intramuscular

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2011-09-30
• Last updated: 2015-03-18

Locations

1 site across 1 country: Switzerland