MedTrace Logo

Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox

NCT00226499 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5803

Last updated 2019-09-23

Study results available
· View outcomes & findings →

Summary

An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Varicella
  • Chickenpox Vaccines

Interventions

BIOLOGICAL

Priorix-tetra™

2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group

BIOLOGICAL

Priorix™

2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group

BIOLOGICAL

Varilrix™

1 dose administered subcutaneously at Day 42 to subjects in OKAH Group

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Months
Max Age
22 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-01
Primary Completion
2006-10-12
Completion
2006-10-12

Countries

  • Czechia
  • Greece
  • Italy
  • Lithuania
  • Norway
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Sweden

Study Locations

More Related Trials

Entities

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 NCT00226499 on ClinicalTrials.gov