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Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age

NCT00970307 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2020-01-03

Study results available
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Summary

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.

Conditions

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

Interventions

BIOLOGICAL

GSK2202083A vaccine

Intramuscular, three doses

BIOLOGICAL

10-valent pneumococcal vaccine (GSK 1024850A)

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
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-13
Primary Completion
2010-01-27
Completion
2010-01-27

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 NCT00970307 on ClinicalTrials.gov