CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,803 enrolled
Drug / intervention
Priorix-tetra™ +2 morebiological
Likely dose
Priorix-tetra: 2 doses administered subcutaneously at Day 0 and Day 42; Varilrix: 1 dose administered subcutaneously at Day 42 (when given with Priorix in OKAH group)AI-extracted
Key inclusion· 4
  • ✓Male or female child aged 12-22 months at first vaccination
  • ✓Free of obvious health problems on medical history and physical examination
  • ✓At least one unvaccinated sibling at home, OR attending daycare/childcare, OR in weekly contact (≥5 min close play) with other children without known varicella history
  • ✓Parents/guardians able and willing to comply with protocol and have direct telephone/mobile access
Key exclusion· 12
  • ✕Prior vaccination against measles, mumps, rubella, and/or varicella
  • ✕History of measles, mumps, rubella, varicella, or herpes zoster disease
  • ✕Known exposure to measles, mumps, rubella, varicella, or herpes zoster within 30 days before study start
  • ✕Immunosuppressant or immune-modifying drug use for >14 days within 6 months before first vaccine dose

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00226499
NCT00226499Phase 3Completed
CompareCT.gov

Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine

GlaxoSmithKline·interventional·Posted Sep 27, 2005·Updated Sep 23, 2019

In Brief

A Phase 3 clinical trial evaluating Priorix-tetra™, Priorix™, and 1 other intervention for Varicella and Chickenpox Vaccines. Completed, enrolled 5,803 participants across 104 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaricella, Chickenpox Vaccines
CountriesCzechia, Greece, Italy, Lithuania, Norway, Poland, Romania, Russia, Slovakia, Sweden
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2005
Enrollment StartSep 1, 2005
Primary CompletionOct 12, 2006
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.8 years ago

Interventions

Priorix-tetra™biological

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

Priorix™biological

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

Varilrix™biological

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