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Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose

NCT01171989 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2020-01-21

Study results available
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Summary

The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine.

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 = NCT00970307).

Conditions

  • Tetanus
  • Diphtheria
  • Haemophilus Influenzae Type b
  • Hepatitis B
  • Poliomyelitis
  • Acellular Pertussis
  • Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni

Interventions

BIOLOGICAL

GSK2202083A vaccine

Intramuscular, one dose.

BIOLOGICAL

Infanrix hexa™

Intramuscular, one dose.

BIOLOGICAL

Menjugate™

Intramuscular, one dose.

BIOLOGICAL

NeisVac-C™

Intramuscular, one dose.

BIOLOGICAL

Synflorix™

Intramuscular, one dose.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-08-18
Primary Completion
2010-12-03
Completion
2010-12-03

Countries

  • Poland

Study Locations

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Entities

Diseases
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 NCT01171989 on ClinicalTrials.gov