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Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

NCT00871741 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-06-06

Study results available
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Summary

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.

Conditions

  • Tetanus
  • Poliomyelitis
  • Neisseria Meningitidis
  • Haemophilus Influenzae Type b
  • Diphtheria
  • Acellular Pertussis
  • Hepatitis B

Interventions

BIOLOGICAL

GSK2202083A vaccine

Intramuscular, three doses

BIOLOGICAL

Infanrix hexa

Intramuscular, three doses

BIOLOGICAL

Menjugate

Intramuscular, two doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Weeks
Max Age
16 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-01
Primary Completion
2009-06-25
Completion
2009-06-25

Countries

  • Slovakia

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 NCT00871741 on ClinicalTrials.gov