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Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children

NCT01027845 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2019-11-29

Study results available
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Summary

This study will aim to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of age.

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

Pneumococcal vaccine GSK1024850A

Intramuscular injection, 4 doses

BIOLOGICAL

DTPa

Subcutaneous injection, 4 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
90 Days
Max Age
118 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-08
Primary Completion
2010-08-13
Completion
2011-09-17

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT01027845 on ClinicalTrials.gov