NCT02570126

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.

Safety and Immunogenicity Study of 2 Formulations of GSK Biologicals' Varicella Vaccines Given as a 2-dose Course in the Second Year of Life.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,236 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

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.

Detailed description

GSK Biologicals has removed human serum albumin (a stabilizer) from its varicella vaccine to minimize as much as possible the use of animal or human-derived products in the production of vaccines. The study is intended to provide information on the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' candidate varicella vaccine formulated without human serum albumin (HSA) in contrast to Varilrix™ (GSK) which contains HSA when both are used in a two-dose schedule, with the first and second doses given approximately 42 days apart in the second year of life. The immunogenicity sub-cohort will be comprised of approximately 400 subjects, representing approximately 100 subjects enrolled in each of the participating countries. Rationale for amendment 1: Sites in the UK can perform home visits. For subjects participating through home visits, the subject's parent(s) / Legally Acceptable Representative(s) \[LAR(s)\] will be requested to sign a Recruitment/Randomisation agreement to provide personal information and to agree to have their child randomised before providing written consent to participate in the study (to be provided at the 1st home visit).

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-13
• Primary completion: 2016-10-25
• Completion: 2016-10-25
• First posted: 2015-10-07
• Last updated: 2019-11-25
• Results posted: 2017-10-11

Locations

23 sites across 5 countries: Estonia, Germany, Mexico, Thailand, United Kingdom