Chickenpox Clinical Trial
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.
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.
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 Varilrixâ„¢ (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).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01887496 -
Varicella-related Hospitalizations in Turkey
|
N/A | |
Completed |
NCT00326183 -
Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
|
Phase 4 | |
Completed |
NCT02452229 -
Review of Human Herpes Viruses in Burns
|
N/A | |
Completed |
NCT01815073 -
Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
|
Phase 4 | |
Completed |
NCT01817270 -
Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine
|
Phase 4 | |
Active, not recruiting |
NCT01982409 -
Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children
|
Phase 4 | |
Completed |
NCT00921999 -
Immune Response to Varicella-Zoster Vaccination and Infection
|
N/A | |
Completed |
NCT00098046 -
Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
|
Phase 3 | |
Completed |
NCT05732337 -
Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device.
|
N/A | |
Completed |
NCT01684072 -
Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin
|
Phase 4 | |
Completed |
NCT00156559 -
MMR and Varicella Vaccine in Premature Infants
|
Phase 4 | |
Active, not recruiting |
NCT05084508 -
A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age
|
Phase 2 | |
Completed |
NCT04384016 -
Safety and Immunogenicity of Skyvaricella Injection in Healthy Volunteer Vietnamese Children From 12 Months to 12 Years Old
|
Phase 4 | |
Completed |
NCT00002358 -
A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV
|
Phase 3 | |
Completed |
NCT00000953 -
Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
|
Phase 2 | |
Completed |
NCT00002315 -
A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems
|
Phase 3 | |
Completed |
NCT00001125 -
Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox
|
Phase 1 | |
Withdrawn |
NCT00001054 -
The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
|
Phase 1 |