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Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children

NCT00950833 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 466

Last updated 2018-09-20

Study results available
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Summary

The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.

This protocol posting deals with objectives \& outcome measures of the extension phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

Pneumococcal vaccine GSK1024850A

1 or 2 intramuscular injections

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
31 Months
Max Age
44 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-10
Primary Completion
2010-09-16
Completion
2010-10-27

Countries

  • Czechia

Study Locations

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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 NCT00950833 on ClinicalTrials.gov