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Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines

NCT00547248 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2019-01-14

Study results available
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Summary

The purpose of this observer blind study is to assess the safety in terms of fever \>39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study.

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00344318)

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

Synflorix

Intramuscular injection, 1 dose

BIOLOGICAL

Tritanrix-HepB

Intramuscular injection, 1 dose

BIOLOGICAL

Hiberix

Reconstituted with Tritanrix-Hep B before injection

BIOLOGICAL

Polio Sabin

Oral, 1 dose

BIOLOGICAL

Poliorix

Intramuscular injection, 1 dose

BIOLOGICAL

Prevenar (Wyeth)

Intramuscular injection, 1 dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-10-22
Primary Completion
2008-05-10
Completion
2008-10-07

Countries

  • Philippines
  • Poland

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 NCT00547248 on ClinicalTrials.gov