A Phase III, double blind, randomized, comparative study of the safety and immunogenicity of GSK Biologicals’ Varilrix HSA-free varicella vaccine and Varilrix™ given as a 2 dose course in the second year of life - OKAH-193

GlaxoSmithKline Biologicals0 sites1,220 target enrollmentJuly 30, 2015

DrugsVARILRIX

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 1220
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 30, 2015

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•A male or female between, and including, 12 and 23 months of age (i.e. 12 months to a day before 24 months) at the time of the first study vaccination.
•Written informed consent obtained from the par\-ent(s)/LAR(s) of the subject prior to performing any study specific procedure.
•Subjects in stable health as determined by investigator’s clinical examination and assessment of subject’s medical history.
•Subjects must have had prior administration of a dose of measles, mumps and rubella (MMR) vaccine at least 30 days (Day \-31 or earlier) prior to study vaccination at Day 0
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1220
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

•Child in care.
•Use of any investigational or non\-registered product other than the study vaccines during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Visit 1/Day 0\) or planned use during the entire study period.
•Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non\-investigational product.
•Chronic administration (defined as 14 or more consecutive days) of immunosuppressants, or other immune\-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immuno\-suppressive and immune\-modifying drugs during the entire study.
•?\-For corticosteroids, this will mean prednisone \=0\.5 mg/kg/day or equivalent.
•?\-Inhaled and topical steroids are allowed.
•Planned administration/ administration of a live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1/Day 0 until study end. Non study live viral vaccines can be administered at Visit 3 (Day 84\) after completion of study procedures.
•Planned administration/ administration of an inactivated vaccine not foreseen by the study protocol during the period starting 7 days prior to each vaccination (at Visit 1/Day 0 and Visit 2/Day 42\) and ending 14 days after each vaccination. Outside of this period, non\-study inactivated vaccines can be administered as per standard of care.
•Administration of immunoglobulins and/or any blood prod\-ucts during the period starting 180 days prior to the first vaccine dose or planned administration from the date of first study vaccination through the entire study.
•History of varicella or zoster.