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

NCT01444352 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-03-18

No results posted yet for this study

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.

Conditions

  • Pneumococcal Infections
  • Streptococcus Pneumoniae Infections
  • Pneumococcal Pneumonia

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01444352 on ClinicalTrials.gov