A Phase III, Observer-blind, Randomized, Multicenter Study to Evaluate Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid as Compared to GSK's Rotarix Liquid, Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 13
- 主要终点
- Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs)
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of the Porcine circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals' SA (GSK) oral live attenuated human rotavirus (HRV) study intervention compared to GSK's liquid oral live attenuated HRV study intervention in healthy Chinese infants 6 to 16 weeks of age at the time of the first study intervention administration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study will be conducted in an observer-blind manner.
入排标准
- 年龄范围
- 6 Weeks 至 16 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants' parent(s)/legally acceptable representative(s) [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 parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- •A male or female with Chinese origin, between, and including, 6 and 16 weeks (42-112 days) of age at the time of the first study intervention administration.
- •Healthy participants as established by medical history and clinical examination before entering into the study.
- •Born after a gestation period of 36 to 42 weeks inclusive.
排除标准
- •Medical conditions
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of severe combined immunodeficiency.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
- •History of seizures or progressive neurological disease.
- •Family history of congenital or hereditary immunodeficiency.
- •Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception (IS).
- •History of IS.
- •Major congenital defects, or serious chronic illness as assessed by the investigator.
- •Previous confirmed occurrence of rotavirus gastroenteritis (RVGE).
- •Participants with confirmed or suspected Coronavirus Disease 2019 (COVID-19).
- •Prior/Concomitant therapy
- •Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or planned use during the study period.
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the second dose of study intervention administration*, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.
- •*In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization programme, the time period described above can be reduced if, necessary for that mass vaccination vaccine, provided it is licensed and used according to its Product Information.
- •Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period.
- •Administration of long-acting immune-modifying drugs from birth or planned administration at any time during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 milligram/kilogram (kg)/day, or equivalent. Inhaled and topical steroids are allowed.
- •Previous vaccination against RV.
- •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 vaccine/product.
- •Other exclusions
- •Child in care.
研究组 & 干预措施
Human Rotavirus (HRV) Group
Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.
干预措施: GSK's liquid oral live attenuated HRV (Combination Product)
HRV Porcine Circovirus (PCV)-free Group
Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.
干预措施: PCV-free liquid formulation of GSK's oral live attenuated HRV (Combination Product)
结局指标
主要结局
Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs)
时间窗: At Month 2 (1-month post-Dose 2)
Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate
时间窗: At Month 2 (1-month post-Dose 2)
Seroconversion rate is defined as the percentage of participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration below \[\<\] 20 unit per milliliter \[U/mL\] prior the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (\>=) 20 U/mL at Month 2 (1-month post-Dose 2).
次要结局
- Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL(At Month 2 (1-month post-Dose 2))
- Number of Participants Reporting Solicited Systemic Events(Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1))
- Number of Participants Reporting Unsolicited Adverse Events (AEs)(Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1))
- Number of Participants Reporting Serious Adverse Events (SAEs)(From Day 1 to Month 7)