NCT01446926

Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants

Safety and Immunogenicity of Pneumococcal Protein Vaccine (PPrV) in Healthy Adults, Toddlers and Infants in Bangladesh

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Weeks – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to explore the safety and tolerability of an investigational pneumococcal vaccine through a step-down enrollment. Primary Objective: * To evaluate the safety and tolerability of an investigational pneumococcal vaccine. Secondary Objective: * To evaluate the immunogenicity of an investigational pneumococcal vaccine.

Detailed description

All adult participants will receive a single injection of study vaccine or placebo. After satisfactory safety evaluation, toddler participants will receive a single injection of study vaccine or placebo. After satisfactory safety evaluation, infant participants will receive 3 injections of study vaccine or placebo in dose-ascending order (low, medium, and high dose), with a safety evaluation after each dose level before the study proceeds to the next higher dose. All participants will undergo immunogenicity testing and monitoring for safety.

Conditions

• Pneumonia
• Pneumococcal Infections
• Streptococcus Pneumoniae Infections

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal Vaccine High Dose (Formulation 1)	0.5 mL, Intramuscular
BIOLOGICAL	Tris buffered saline (Placebo)	0.5 mL, Intramuscular
BIOLOGICAL	Pneumococcal Vaccine High Dose (Formulation 1)	0.5 mL, Intramuscular
BIOLOGICAL	Tris buffered saline (Placebo)	0.5 mL, Intramuscular
BIOLOGICAL	Pneumococcal Vaccine Low Dose (Formulation 2)	0.5 mL, Intramuscular
BIOLOGICAL	Tris buffered saline (Placebo)	0.5 mL, Intramuscular
BIOLOGICAL	Pneumococcal Vaccine Middle Dose (Formulation 3)	0.5 mL, Intramuscular
BIOLOGICAL	Pneumococcal Vaccine Middle Dose (Formulation 4)	0.5 mL, Intramuscular
BIOLOGICAL	Tris buffered saline (Placebo)	0.5 mL, Intramuscular
BIOLOGICAL	Pneumococcal Vaccine High Dose (Formulation 1)	0.5 mL, Intramuscular
BIOLOGICAL	Tris buffered saline (Placebo)	0.5 mL, Intramuscular

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2011-10-05
• Last updated: 2018-01-10

Locations

1 site across 1 country: Bangladesh