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Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants

NCT00169442 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 745

Last updated 2018-06-06

Study results available
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Summary

To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.

Conditions

  • Whole Cell Pertussis
  • Diphtheria
  • Hepatitis B
  • Tetanus
  • Haemophilus Influenzae Type b

Interventions

BIOLOGICAL

Tritanrix™-HepB/Hiberix™ Kft.

GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.

BIOLOGICAL

Tritanrix™-HepB/Hiberix™

GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine

BIOLOGICAL

Hiberix™

GSK Biologicals' Haemophilus influenzae type b vaccine

BIOLOGICAL

Polyribosil-Ribitol-Phosphate (PRP) vaccine

plain PRP polysaccharide vaccine

BIOLOGICAL

Tritanrix™-HepB Kft

GSK Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-10
Primary Completion
2006-03-01
Completion
2006-03-10

Countries

  • Philippines

Study Locations

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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 NCT00169442 on ClinicalTrials.gov