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

NCT01086423 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 985

Last updated 2018-06-06

Study results available
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Summary

The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.

Conditions

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

Interventions

BIOLOGICAL

Infanrix-IPV/Hib™

Intramuscular, three doses

BIOLOGICAL

Infanrix Hib™

Intramuscular, three doses

BIOLOGICAL

Poliorix™

Intramuscular, three doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-01
Primary Completion
2010-11-19
Completion
2010-11-19

Countries

  • China

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 NCT01086423 on ClinicalTrials.gov