Clinical Trial: 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.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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).


Sponsor: GlaxoSmithKline

Current Primary Outcome: Assessment of fever after varicella vaccination post Dose 1 [ Time Frame: From Day 0 through Day 14 after dose 1 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Assessment of fever after varicella vaccinations [ Time Frame: From Day 0 through Day 14 after each vaccination ]
  • Immune response to varicella vaccine post dose 1 (Day 42) and post dose 2 (Day 84) (immuno-subcohort) [ Time Frame: 42 days after each vaccination ]
  • Solicited local and general symptoms [ Time Frame: From Day 0 to Day 3 after each vaccination for solicited local symptoms. 42 days after each vaccination for solicited general symptoms ]
  • Unsolicited adverse events [ Time Frame: For 42 days after each vaccination day ]
  • Serious adverse events [ Time Frame: From Day 0 through the end of study (Day 0 - Day 84) ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: October 5, 2015
Date Started: November 2015
Date Completion:
Last Updated: March 14, 2017
Last Verified: March 2017