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Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

NCT01457508 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2017-06-16

No results posted yet for this study

Summary

This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.

Conditions

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

Interventions

BIOLOGICAL

DTPa-HBV-IPV/Hib (Infanrix hexa™)

Three doses administered intramuscularly

BIOLOGICAL

DTPa-HBV-IPV (Infanrix penta™)

Three doses administered intramuscularly

BIOLOGICAL

Hib (Hiberix™)

Three doses administered intramuscularly

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
1999-01-31
Primary Completion
2000-03-31
Completion
2000-03-31

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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 NCT01457508 on ClinicalTrials.gov