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Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

NCT00611559 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2018-06-06

Study results available
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Summary

The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study.

The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group.

Conditions

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

Interventions

BIOLOGICAL

Infanrix™ penta

Subjects received a booster dose

BIOLOGICAL

Infanrix™ hexa

Subjects received a booster dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-02-14
Primary Completion
2008-06-25
Completion
2008-06-25

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 NCT00611559 on ClinicalTrials.gov