A Phase 3a, Observer-blind, Randomized, Controlled, Study to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, When Given as a Second Dose to Healthy Children, 3 Months After the Administration of a First Dose at 12 to 15 Months of Age
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) IgG for 2 doses of VNS vaccine compared to 2 doses of VV
研究概览
简要总结
The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Observer-blind study.
入排标准
- 年龄范围
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant's parent(s)/Legally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- •Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure.
- •Healthy participants as established by medical history and clinical examination before entering into the study.
- •A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1 year birthday until the day before 16 months of age) at the time of the administration of the first study interventions.
- •Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions: participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry.
排除标准
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Hypersensitivity to latex.
- •Major congenital defects, as assessed by the investigator.
- •Recurrent history of uncontrolled neurological disorders or seizures.
- •History of varicella disease.
- •Active untreated tuberculosis.
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- •Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or their planned use during the study period.
- •Planned administration of a vaccine in the period starting 30 days before the first dose and ending 43 days after the second dose of study interventions administration (Visit 3), with the exception of inactivated influenza vaccine which may be given at any time during the study and administered at a different location than the study interventions.
- •Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
- •Up to 90 days prior to the study intervention administration:
- •i) For corticosteroids, this will mean prednisone equivalent >=0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed.
- •ii) Administration of immunoglobulins and/or any blood products or plasma derivatives.
- •Up to 180 days prior to study interventions administration: long acting immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study vaccinese.g., nirsevimab), antitumoral medication.
- •Previous vaccination against measles, mumps, and rubella.
- •Previous vaccination against hepatitis A virus.
- •Previous vaccination against varicella virus.
- •Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions, participant who previously received a booster dose of any PCV.
- •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).
- •Child in care.
- •Any study personnel's immediate dependents, family, or household members.
- •Participants with the following high-risk individuals in their household:
- •i) Immunocompromised individuals. ii) Pregnant women without documented history of varicella. iii) Newborn infants of mothers without documented history of varicella. iv) Newborn infants born less than (<) 28 weeks of gestation.
研究组 & 干预措施
VV-VNS Group
Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: PCV 20 (Biological)
VV-VV Group
Participants receive 2 doses of a VV vaccine on Day 1 and Day 91. 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: PCV 20 (Biological)
VNS-VNS Group
Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: PCV 20 (Biological)
VV-VNS Group
Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: MMR vaccine (Biological)
VNS-VNS Group
Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: Investigational varicella vaccine (Biological)
VNS-VNS Group
Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: MMR vaccine (Biological)
VV-VV Group
Participants receive 2 doses of a VV vaccine on Day 1 and Day 91. 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: Marketed varicella vaccine (Biological)
VV-VV Group
Participants receive 2 doses of a VV vaccine on Day 1 and Day 91. 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: Vaxneuvance (Biological)
VV-VNS Group
Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: Investigational varicella vaccine (Biological)
VV-VNS Group
Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: Marketed varicella vaccine (Biological)
VV-VNS Group
Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: Hepatitis A vaccine (Biological)
VV-VV Group
Participants receive 2 doses of a VV vaccine on Day 1 and Day 91. 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: MMR vaccine (Biological)
VV-VV Group
Participants receive 2 doses of a VV vaccine on Day 1 and Day 91. 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: Hepatitis A vaccine (Biological)
VV-VV Group
Participants receive 2 doses of a VV vaccine on Day 1 and Day 91. 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: PCV (pneumococcal conjugate vaccine) 13 (Biological)
VNS-VNS Group
Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: Hepatitis A vaccine (Biological)
VNS-VNS Group
Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: PCV (pneumococcal conjugate vaccine) 13 (Biological)
VNS-VNS Group
Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: Vaxneuvance (Biological)
VV-VNS Group
Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: PCV (pneumococcal conjugate vaccine) 13 (Biological)
VV-VNS Group
Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
干预措施: Vaxneuvance (Biological)
结局指标
主要结局
Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) IgG for 2 doses of VNS vaccine compared to 2 doses of VV
时间窗: At Day 133 (43 days post-dose 2)
Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti VZV gE Immunoglobulin (IgG) concentration greater than equal to (\>=) 300 milli-international units per milliliter (mIU/mL).
Geometric Mean Concentration (GMC) of anti-VZV gE IgG for 2 doses of VNS vaccine compared to 2 doses of VV
时间窗: At Day 133 (within 43 days post-dose 2)
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU/mL for each group.
次要结局
- Percentage of participants with seroresponse to anti-VZV gE IgG for VV-VNS group(At Day 133 (within 43 days post-dose 2))
- GMC of anti-VZV gE IgG for VV-VNS group(At Day 133 (within 43 days post-dose 2))
- Percentage of participants reporting each solicited administration site event(Day 91 (post-dose 2) to Day 133)
- Percentage of participants reporting each solicited systemic event(Day 91 (post-dose 2) to Day 133)
- Percentage of participants reporting each solicited systemic event in terms of fever(Day 91 (post-dose 2) to Day 112)
- Percentage of participants reporting unsolicited adverse events (AEs)(Day 91 (post-dose 2) to Day 133)
- Percentage of participants reporting medically attended AEs (MAAE)(Day 1 (post-dose 1) to Day 271 (study end))
- Percentage of participants reporting serious adverse events (SAEs)(Day 1 (post-dose 1) to Day 271 (study end))