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Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

NCT01457495 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2017-06-16

No results posted yet for this study

Summary

This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.

Conditions

  • Hepatitis B
  • Diphtheria
  • Haemophilus Influenzae Type b (Hib)
  • Poliomyelitis
  • Pertussis
  • Tetanus

Interventions

BIOLOGICAL

DTPa-HBV-IPV/Hib (Infanrix-hexa™)

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

BIOLOGICAL

DTPa-IPV/Hib (Infanrix-IPV/Hib™)

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

BIOLOGICAL

HBV (Engerix™-B)

3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Weeks
Max Age
16 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-09-30
Primary Completion
1999-09-30
Completion
1999-09-30

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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 NCT01457495 on ClinicalTrials.gov