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 个研究点目标入组 800 人开始时间: 2022年11月22日最近更新: 2023年8月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 800

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•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
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•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.
•Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
•Prior and Concomitant Therapy
•Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants, or
•other immune-modifying drugs during the period starting 90 days prior to the study
•interventions administration. For corticosteroids, this will mean prednisone equivalent = 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
•Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period.
•Administration of long-acting immune-modifying drugs at any time during the study period
•(e.g., infliximab).
•Previous vaccination against measles, mumps, rubella, hepatitis A, and/or varicella virus.
•Previous administration of a booster dose of any pneumococcal conjugate vaccine.
•Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending at 43 days after the dose of study
•interventions administration* (Visit 3) with the exception of inactivated influenza (flu)
•vaccine which may be given at any time during the study and administered at a different
•location than the study interventions.
•Any other age-appropriate vaccine may be given starting at Visit 3 and anytime thereafter.
•*In case of emergency mass vaccination for an unforeseen public health threat (e.g., a
•pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor/designee is notified accordingly.
•Prior/Concurrent Clinical Study Experience
•Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device [see the definition in Appendix 1 of the protocol])
•Other Exclusions
•Child in care (see the definition in Appendix 1 of the protocol).
•Any study personnel’s immediate dependents, family, or household members.
•Participants with the following high-risk individuals in their household:
•- Immunocompromised individuals.
•- Pregnant women without documented history

研究者

发起方

GlaxoSmithKline Biologicals SA (GSK)

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