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Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine

NCT01309646 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2019-11-27

Study results available
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Summary

This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.

Conditions

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

Interventions

BIOLOGICAL

Infanrix™-IPV+Hib

Intramuscular, 3 doses

BIOLOGICAL

Infanrix™ IPV

Intramuscular, 3 doses

BIOLOGICAL

Hiberix™

Intramuscular, 3 doses

BIOLOGICAL

Synflorix™

Intramuscular, 3 doses

BIOLOGICAL

Rotarix™

Oral, 2 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
69 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-04
Primary Completion
2012-02-24
Completion
2012-02-24

Countries

  • South Korea

Study Locations

More Related Trials

Entities

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 NCT01309646 on ClinicalTrials.gov