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Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers

NCT01323647 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 957

Last updated 2019-02-11

Study results available
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Summary

This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

PoliorixTM

Single dose, intramuscular administration

BIOLOGICAL

Infanrix+Hib

Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-04-25
Primary Completion
2011-09-19
Completion
2011-09-19

Countries

  • China

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 NCT01323647 on ClinicalTrials.gov