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Study of Two Investigational Pneumococcal Vaccines in Healthy Adults

NCT01444339 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2011-09-30

No results posted yet for this study

Summary

This study is designed to evaluate the safety, tolerability, and immunogenicity of two investigational pneumococcal vaccines at three dose levels in healthy adults.

Primary Objective:

\- To evaluate the safety and tolerability of two investigational pneumococcal vaccines.

Observational Objective:

\- To evaluate the immunogenicity of the investigational pneumococcal vaccines.

Conditions

  • Pneumococcal Infections
  • Streptococcus Pneumoniae Infections
  • Pneumococcal Pneumonia

Interventions

BIOLOGICAL

Pneumococcal Vaccine Formulation 1

0.5 mL, intramuscular (1 middle dose)

BIOLOGICAL

Pneumococcal Vaccine Formulation 2

0.5 mL, intramuscular (2 low doses)

BIOLOGICAL

Pneumococcal Vaccine Formulation 3

0.5 mL, intramuscular (2 middle doses)

BIOLOGICAL

Pneumococcal Vaccine Formulation 4

0.5 mL, intramuscular (2 middle doses)

BIOLOGICAL

Pneumococcal Vaccine Formulation 5

0.5 mL, intramuscular (2 high doses)

BIOLOGICAL

Placebo

0.5 mL, intramuscular

Sponsors & Collaborators

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
2010-02-28
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01444339 on ClinicalTrials.gov