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Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population

NCT00327665 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2017-05-08

No results posted yet for this study

Summary

As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up.

This protocol posting details the procedures of both the primary \& extension phase.

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

11-valent pneumococcal vaccine GSK513026

Two-dose intramuscular injection. Each group receiving one of the 3 formulations

BIOLOGICAL

Pneumo 23™

Single-dose intramuscular injection.

BIOLOGICAL

Placebo

1 intramuscular injection.

BIOLOGICAL

10-valent pneumococcal vaccine GSK513026

Two-dose intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-01
Primary Completion
2007-01-01
Completion
2007-01-08

Countries

  • Belgium
  • Finland
  • Sweden

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 NCT00327665 on ClinicalTrials.gov