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

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.

Conditions

• Pneumonia
• Pneumococcal Infections
• Streptococcus Pneumoniae Infections

Interventions

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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company

  lead INDUSTRY

Principal Investigators

• Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2013-03-31

Completion

2013-06-30

Countries

• Bangladesh

Study Locations