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Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents

NCT01362322 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 671

Last updated 2018-08-10

Study results available
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Summary

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years.

Conditions

  • Diphtheria
  • Tetanus
  • Acellular Pertussis

Interventions

BIOLOGICAL

Boostrix TM (new syringe presentation)

Single dose, intramuscular administration in a new syringe presentation

BIOLOGICAL

Boostrix TM (previous syringe presentation)

Single dose, intramuscular administration in previous syringe presentation

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-01
Primary Completion
2012-09-03
Completion
2012-09-03

Countries

  • Chile
  • Mexico

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 NCT01362322 on ClinicalTrials.gov