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Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

NCT00907777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-11-23

Study results available
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Summary

The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.

Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 4. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).

Conditions

  • Infections, Streptococcal
  • Streptococcus Pneumoniae

Interventions

BIOLOGICAL

Pneumococcal conjugate vaccine GSK 1024850A

One dose of vaccine will be injected intramuscularly into the deltoid.

BIOLOGICAL

Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)

One dose of vaccine will be injected intramuscularly into the deltoid.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
46 Months
Max Age
50 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-23
Primary Completion
2009-10-05
Completion
2009-10-05

Countries

  • Germany

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 NCT00907777 on ClinicalTrials.gov