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Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course

NCT01457547 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2016-08-05

No results posted yet for this study

Summary

The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.

Conditions

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

Interventions

BIOLOGICAL

DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)

Three doses administered intramuscularly

BIOLOGICAL

DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)

Three doses administered intramuscularly

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Weeks
Max Age
15 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2005-05-31
Completion
2005-05-31

Countries

  • Finland
  • Italy
  • Sweden

Study Locations

More Related Trials

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 NCT01457547 on ClinicalTrials.gov