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A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age.

NCT02570126 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1236

Last updated 2019-11-25

Study results available
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Summary

The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life.

Conditions

  • Chicken-pox Illness (Varicella Virus Disease)
  • Chickenpox

Interventions

BIOLOGICAL

Varilrix HSA-free

2 doses will be administered, one at Day 0 and the other at Day 42

BIOLOGICAL

Varilrix™

2 doses will be administered, one at Day 0 and the other at Day 42

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-11-13
Primary Completion
2016-10-25
Completion
2016-10-25

Countries

  • Estonia
  • Germany
  • Mexico
  • Thailand
  • United Kingdom

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 NCT02570126 on ClinicalTrials.gov