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Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

NCT01090453 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2018-08-20

Study results available
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Summary

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.

Conditions

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

Interventions

BIOLOGICAL

GSK2202083A vaccine

3 doses given at 2, 4 and 12 months of age

BIOLOGICAL

Prevenar 13®

3 co-administered doses

BIOLOGICAL

Infanrix hexa™

3 doses given at 2, 4 and 12 months of age

BIOLOGICAL

Menjugate®

3 co-administered doses

BIOLOGICAL

Rotarix™

Oral, 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
2010-05-17
Primary Completion
2011-10-11
Completion
2011-10-11

Countries

  • Canada
  • France
  • Germany

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 NCT01090453 on ClinicalTrials.gov