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Booster and Catch-up Vaccination With Vaccine GSK1024850A

NCT01030822 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2018-09-20

Study results available
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Summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18 months of age in children primed in primary study NCT00814710.

This study also aims to assess the persistence of antibodies induced following primary vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to booster vaccination and following vaccination in the present study at approximately 24 months of age.

The study is also designed to evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

Pneumococcal vaccine GSK1024850A

Intramuscular injection, administered as a single dose

BIOLOGICAL

Pneumococcal vaccine GSK1024850A

Intramuscular injection, 3 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-02
Primary Completion
2011-08-19
Completion
2011-08-19

Countries

  • India

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 NCT01030822 on ClinicalTrials.gov