Clinical Trial: Study of Two Formulations of GSK Biologicals' Varicella Vaccine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Study of Two Formulations of GSK Biologicals' Varicella Vaccine Given as a 2-dose Course in the Second Year of Life
Brief Summary: The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety. This present study is undertaken to rule out any negative impact on the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: GMT ratio for antibodies to varicella [ Time Frame: post-dose 1 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Seroconversion rates for varicella antibodies [ Time Frame: post-dose 1 and post-dose 2 ]
- GMTs for varicella antibodies [ Time Frame: post-dose 2 ]
- Solicited symptoms after each vaccination (pain, redness, swelling: Day 0-3; fever; rash: Day 0-42) [ Time Frame: Day 0-3, Day 0-42 ]
- Unsolicited AEs after each vaccination [ Time Frame: Day 0-42 ]
- SAEs [ Time Frame: from dose 1 up to study end ]
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: December 5, 2007
Date Started: November 2007
Date Completion:
Last Updated: November 2, 2016
Last Verified: November 2016
