A phase II, observer-blind, randomized, controlled study to evaluate the immunogenicity and safety of a varicella vaccine at various potencies compared with Varivax, as a first dose, administered in healthy children in their second year of life

GlaxoSmithKline Biologicals SA (GSK)0 sites800 target enrollmentNovember 22, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Immunogenicity and safety of a varicella vaccine in healthy children
Sponsor: GlaxoSmithKline Biologicals SA (GSK)
Enrollment: 800
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

November 22, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GlaxoSmithKline Biologicals SA (GSK)

•Healthy participants as established by medical history and clinical examination before entering into the study.
•A male or female between, and including, 12 and 15 months of age (i.e., from his/her 1\-year birthday until the day before age of 16 months) at the time of the administration of the study interventions.
•Written informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study\-specific procedure.
•Participants’ parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g., completion of eDiaries, return for follow\-up visits).
•Only for US participants and participants in countries where pneumococcal conjugate
•vaccine is recommended at 12\-15 months of life as per national immunization schedule:
•Participants who previously received the primary series of pneumococcal conjugate vaccine in their first year of life with the last dose at least 60 days prior to study entry.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 800
•F.1\.2 Adults (18\-64 years) no

•Medical Conditions
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the
•study interventions including hypersensitivity to neomycin or gelatin.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
•medical history and physical examination (no laboratory testing required).
•Hypersensitivity to latex.
•Major congenital defects, as assessed by the investigator.
•History of varicella.
•Recurrent history of or uncontrolled neurological disorders or seizures.
•Participant with history of SARS\-CoV\-2 infection who is still symptomatic.