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Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants

NCT00158756 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2018-06-06

Study results available
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Summary

To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.

Conditions

Interventions

BIOLOGICAL

Tritanrix™-HepB

GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.

BIOLOGICAL

Rotarix™

GSK Biologicals' live attenuated human rotavirus vaccine

BIOLOGICAL

Zilbrix™

GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine

BIOLOGICAL

Triple Antigen™

Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.

BIOLOGICAL

Engerix™-B

GSK Biologicals' hepatitis B vaccine

DRUG

Placebo

Placebo for the Rotarix™ vaccine

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
4 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-12
Primary Completion
2006-11-01
Completion
2006-11-23

Countries

  • Russia

Study Locations

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Entities

Drugs
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 NCT00158756 on ClinicalTrials.gov