Clinical Trial: Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox

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

Official Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Comb

Brief 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.

Detailed Summary:

According to treatment group allocation, participants will receive study vaccines and be followed for antibody titres and occurrence of varicella disease.

This study is conducted in 2 phases. Phase A includes the vaccination period and an observation period for efficacy. The efficacy endpoints will be evaluated over at least two years after vaccination. During this period, the immunogenicity endpoints will be evaluated with respect to the immune response 43 days after vaccination and the persistence of antibodies over two years to varicella (for all subjects) and to measles, mumps and rubella (for a subset of subjects). Regarding the safety endpoints, SAEs (including any complicated varicella cases if observed) will be assessed for all subjects during the whole Phase A duration, whereas, solicited (local and general) and unsolicited adverse events will be assessed in a subset of subjects within a 43-day period after vaccination.

Phase B is an extension of Phase A. It is a long-term follow-up until Year 10 to examine the long-term efficacy of the study vaccines against clinical varicella disease as well as the long-term persistence of antibodies to varicella (for all subjects) and to measles, mumps and rubella (in a subset of subjects) after vaccination.


Sponsor: GlaxoSmithKline

Current Primary Outcome: Occurrence of confirmed varicella cases in all subjects. [ Time Frame: From 42 days post dose 2 until the end of Phase A ]

Original Primary Outcome: Varicella disease/antibody titres

Current Secondary Outcome:

  • Phase A:Occurrence of probable or confirmed varicella cases in all subjects [ Time Frame: From 42 days post dose 2 until the end of Phase A ]
  • Occurence of varicella cases by severity in all subjects [ Time Frame: From 42 days post dose 2 until the end of Phase A ]
  • Occurrence of complicated varicella cases (reported as SAEs) in all subjects [ Time Frame: From Day 0 to Year 2 ]
  • Varicella antibody titres in all subjects [ Time Frame: At Day 0, Day 84, Year 1 and Year 2 time points. ]
  • Measles, mumps and rubella antibody titres in a subset of subjects [ Time Frame: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points. ]
  • Occurrence of SAEs in all subjects [ Time Frame: From Day 0 until the end of Phase A ]
  • Occurrence of herpes zoster in all subjects [ Time Frame: From Day 0 until the end of Phase A ]
  • Occurrence of fever (in a subset of subjects) [ Time Frame: Within 15 days and within 43 days after each vaccination ]
  • Occurrence of any and grade 3 solicited local symptoms (in a subset of subjects) [ Time Frame: Within 4 days after each vaccination ]
  • Occurrence of any and grade 3 solicited general symptoms (in a subset of subjects) [ Time Frame: Within 43 days after each vaccination ]
  • Occurrence of unsolicited symptoms (in a subset of subjects) [ Time Frame: Within 43 days after each vaccination ]
  • Number of hours/days lost from work by parents/guardians as a result of taking care of their child due to varicella [ Time Frame: During Phase A ]
  • Number of hours/days the child lost attendance due to varicella in: day care/childminder, school, or in any extra-curricular activities [ Time Frame: During Phase A ]
  • Number of hours/days spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child due to varicella [ Time Frame: During Phase A ]
  • Phase B:Occurrence of confirmed varicella cases in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ]
  • Occurrence of probable or confirmed varicella cases in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ]
  • Occurrence of varicella cases by severity in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ]
  • Occurence of complicated varicella cases (reported as SAEs) in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ]
  • Varicella antibody titres in all subjects [ Time Frame: At Year 4, Year 6, Year 8 and Year 10 time points ]
  • Measles, mumps and rubella antibody titres in a subset of subjects [ Time Frame: At Year 4, Year 6, Year 8 and Year 10 time points ]
  • Occurrence of SAEs in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ]
  • Occurrence of herpes zoster in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ]
  • Number of hours/days lost from work by parents/guardians as a result of taking care of their child due to varicella [ Time Frame: During the Phase B period ]
  • Number of hours/days the child lost attendance in: day care/childminder, school, or in any extra-curricular activities due to varicella [ Time Frame: During Phase B ]
  • Number of hours/days spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child. [ Time Frame: During Phase B ]


Original Secondary Outcome: Safety of the study vaccines

Information By: GlaxoSmithKline

Dates:
Date Received: September 23, 2005
Date Started: September 2005
Date Completion:
Last Updated: January 12, 2015
Last Verified: January 2015