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Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

NCT01248884 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 721

Last updated 2018-08-20

Study results available
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Summary

This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age.

Conditions

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

Interventions

BIOLOGICAL

Infanrix hexa™

3 doses, intramuscular into left thigh

BIOLOGICAL

Prevenar 13®

3 co-administered doses, intramuscular into right thigh

BIOLOGICAL

GSK217744

3 doses, intramuscular into left thigh

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Days
Max Age
90 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-09
Primary Completion
2012-01-05
Completion
2012-01-05

Countries

  • Dominican Republic
  • Finland

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 NCT01248884 on ClinicalTrials.gov