A Phase 3a, Open-Label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Varicella Vaccine and Priorix Compared With Subcutaneous Administration of Varivax and Priorix, When Given as a First Dose to Healthy Children 12 to 15 Months of Age
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 911
- 试验地点
- 23
- 主要终点
- GMC of Anti-mumps antibodies
研究概览
简要总结
This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.
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
- None
盲法说明
This is an Open Label 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 representatives (LAR[s]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).
- •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 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 the administration of study intervention.
排除标准
- •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.
- •Recurrent history of uncontrolled neurological disorders or seizures.
- •History of measles, mumps, rubella, or varicella disease.
- •Active untreated tuberculosis.
- •Participants with bleeding disorders (e.g., thrombocytopenia or any coagulation disorder).
- •Condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •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/Concomitant therapy
- •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 dose of study interventions administration (Day -29 to Day 1), or their planned use during the study period.
- •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:
- •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.
- •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 vaccines, e.g., nirsevimab), antitumoral medication.
- •Previous vaccination against measles, mumps, and rubella.
- •Previous vaccination against varicella virus.
- •Previous vaccination against hepatitis A 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.
- •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).
- •Other exclusion criteria
- •Any study personnel or their immediate dependents, family, or household members.
- •Child in care.
- •Participants with the following high-risk individuals in their household: • Immunocompromised individuals.
- •Pregnant women without documented history of varicella.
- •Newborn infants of mothers without documented history of varicella.
- •Newborn infants born <28 weeks of gestation
研究组 & 干预措施
VNS+ MMR Vaccine
Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: Candidate varicella vaccine (Biological)
VNS+ MMR Vaccine
Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: MMR vaccine (Biological)
VNS+ MMR Vaccine
Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: Hepatitis A vaccine (Biological)
VV+MMR Vaccine
Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: Marketed varicella vaccine (Biological)
VV+MMR Vaccine
Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: Hepatitis A vaccine (Biological)
VNS+ MMR Vaccine
Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: Vaxneuvance (Biological)
VV+MMR Vaccine
Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: MMR vaccine (Biological)
VNS+ MMR Vaccine
Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: PCV (pneumococcal conjugate vaccine) 13 (Biological)
VV+MMR Vaccine
Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: PCV (pneumococcal conjugate vaccine) 13 (Biological)
VV+MMR Vaccine
Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: Vaxneuvance (Biological)
VNS+ MMR Vaccine
Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: PCV 20 (Biological)
VV+MMR Vaccine
Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
干预措施: PCV 20 (Biological)
结局指标
主要结局
GMC of Anti-mumps antibodies
时间窗: At Day 43
GMC of Anti-rubella antibodies
时间窗: At Day 43
Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG)
时间窗: At Day 43
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti VZV gE IgG concentration is above the seroresponse threshold.
Geometric Mean Concentration (GMC) of anti-VZV gE IgG
时间窗: At Day 43
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in milli-international units per milliliter (mIU/mL) for each group.
Percentage of participants with seroresponse to MMR antigens
时间窗: At Day 43
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti-measles, mumps, and rubella antibody concentrations are above the seroresponse threshold.
GMC of Anti-measles antibodies
时间窗: At Day 43
次要结局
- Percentage of participants with seroresponse to demonstrate an acceptable immune response for IM administration of MMR vaccine(At Day 43)
- Percentage of participants with seroresponse to MMR antigens with a reduced non-inferiority margin(At Day 43)
- Percentage of participants reporting each solicited administration site events post-dose of investigational VNS vaccine or VV administration(Day 1 (post-dose) to Day 4)
- Percentage of participants reporting each solicited administration site events post-dose of MMR vaccine administration(Day 1 (post-dose) to Day 4)
- Percentage of participants reporting each solicited systemic events post-dose of study interventions administration(Day 1 (post-dose) to Day 43)
- Percentage of participants reporting each solicited systemic event in terms of fever post-dose of study interventions administration(Day 1 (post-dose) to Day 22)
- Percentage of participants reporting each solicited administration site events post-dose of study interventions administration(Day 1 (post-dose) to Day 43)
- Percentage of participants reporting unsolicited Adverse Events (AEs) post-dose of study interventions administration(Day 1 (post-dose) to Day 43)
- Percentage of participants reporting medically attended AEs (MAAE) post-dose of study interventions administration(Day 1 (post-dose) to Day 181 (Study end))
- Percentage of participants reporting Serious AEs (SAEs) post-dose of study interventions administration(Day 1 (post-dose) to Day 181 (Study end))