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Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

NCT00320463 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 415

Last updated 2016-10-12

No results posted yet for this study

Summary

In this study, infants will be randomly allocated into three groups:

* one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
* the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)
* the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

Conditions

  • Diphtheria
  • Hepatitis B
  • Poliomyelitis
  • Tetanus
  • Acellular Pertussis

Interventions

BIOLOGICAL

DTPa-HBV-IPV/Hib vaccine

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
11 Weeks
Max Age
17 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-04-30
Completion
2007-01-31

Countries

  • Russia

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 NCT00320463 on ClinicalTrials.gov