A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of SIBP's MMR Vaccine Compared to GSK MMR Vaccine in Children, 9-11 Months of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Difference of seropositivity rate
研究概览
简要总结
To evaluate the Immunogenicity and Safety of Shanghai Institute of Biological Products Co., Ltd.'s Measles, Mumps and Rubella (MMR) Vaccine Compared to a Licensed and WHO Prequalified GSK MMR Vaccine in Healthy African Children, 9-11 Months of Age.
详细描述
This study is designed as a phase III, multi-center, randomized, observer blind active controlled non-inferiority study, enrolling 1200 healthy African children between the ages of 9-11 months. The enrolled children will be randomized to three groups in the ratio of 1:1:1 (400 children in each group) receiving a single dose of SIBP MMR vaccine alone at 1st dose on D1 and licensed YF vaccine alone at 2nd dose on D43 (Group 1, MMR1YF2) or a single dose of GSK MMR vaccine alone at D1 (Group 2, GSK MMR1) or a single dose of SIBP MMR vaccine co-administered with YF vaccine on D1 (Group 3, MMR1YF1). This study will have an observer-blinded phase for Group 1 and Group 2 followed by an open label phase from Day 43. Group 3 will remain an open label arm throughout the period of the study.
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 (Outcomes Assessor)
盲法说明
This study will have an observer-blinded phase for Group 1 and Group 2 followed by an open label phase from Day 43. Group 3 will remain an open label arm throughout the period of the study.
入排标准
- 年龄范围
- 9 Months 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female child as established by medical history and clinical examination at enrollment.
- •Age: 9-11 months (inclusive) at the time of enrollment
- •Parent's/legally acceptable representative's (LAR) ability to read and willingness to provide written informed consent as per the ethical and regulatory requirements of the site.
- •Parent confirms intention to stay in the study area for the study duration, bring their child in for the required study visits or to accept a home visit by the study staff.
排除标准
- •Presence of fever (defined as axillary temperature ≥ 37.5°C) (temporary exclusion until recovery)
- •Acute disease of moderate to severe intensity at the time of enrollment (temporary exclusion until recovery)
- •Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusion until recovery)
- •Prior (within 6 months) or concurrent participation in another interventional clinical trial during the study
- •Presence of severe malnutrition (weight-for-height z-score < -3SD median)
- •Positive test for any of the following: HIV, hepatitis B, hepatitis C and syphilis
- •Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological (including severe anemia), endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant's health or is likely to result in nonconformance to the protocol.
- •Known or suspected impairment of immunological function based on medical history and physical examination.
- •Prior receipt or intent to receive measles, mumps, rubella, or yellow fever-containing vaccine during the study vaccination and follow up period up to Day 85 outside the study center.
- •Receipt of any vaccine (except OPV and inactivated influenza) within 4 weeks of the day of study vaccination or intent to receive any within 6 weeks after study vaccination.
- •Receipt of immunoglobulin therapy and / or blood products in the past 9 months or planned administration during the study period
- •Receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study. A chronic oral or parenteral use (defined as more than 14 days) of high dose corticosteroids (defined as ≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh >10 kg) will be exclusionary for the study. Children on inhaled or topical steroids may be permitted to participate in the study.
- •Evidence of a clinically significant major congenital anomaly or genetic defect as judged by the investigator.
- •Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
- •History of any neurologic disorders including encephalopathy, epilepsy, and other progressive neurological diseases
- •A known or suspected sensitivity or allergy to any components of the investigational product including egg, chicken protein and the antibiotic gentamycin.
- •History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
- •Any medical condition in the parent/LAR or child which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent(s)'/LAR's ability to give informed consent.
研究组 & 干预措施
SIBP MMR vaccine group
Received a single dose of SIBP MMR vaccine alone at 1st dose on D1 and licensed Yellow Fever (YF) vaccine alone at 2nd dose on D43.
干预措施: SIBP MMR Vaccine (Biological)
SIBP MMR vaccine group
Received a single dose of SIBP MMR vaccine alone at 1st dose on D1 and licensed Yellow Fever (YF) vaccine alone at 2nd dose on D43.
干预措施: Yellow Fever Vaccine (Stamaril) (Biological)
GSK MMR vaccine group
Received a single dose of GSK MMR vaccine alone at D1.
干预措施: GSK MMR Vaccine (PRIORIX) (Biological)
Joint vaccination group
Received a single dose of SIBP MMR vaccine co-administered with Yellow Fever vaccine on D1.
干预措施: SIBP MMR Vaccine (Biological)
Joint vaccination group
Received a single dose of SIBP MMR vaccine co-administered with Yellow Fever vaccine on D1.
干预措施: Yellow Fever Vaccine (Stamaril) (Biological)
结局指标
主要结局
Difference of seropositivity rate
时间窗: 42 days
An evaluation of seropositivity rate to Measles, Mumps and Rubella viruses of SIBP MMR vaccine versus GSK MMR vaccine when measured 42 days after vaccination in seronegative children at baseline.
次要结局
- Seropositivity rate of Measles(42 days)
- The percentage of unsolicited AEs(42 days)
- The percentage of serious adverse events (SAEs)(42 days)
- The percentage of solicited local reactogenicity(7 days)
- The percentage of immediate adverse events (AEs)(30 minutes)
- The percentage of solicited systemic reactogenicity(14 days)
- Geometric mean titer (GMT) of Yellow Fever(42 days)
- Geometric mean concentration (GMC) of Measles(42 days)
- Geometric mean concentration (GMC) of Rubella(42 days)
- Seropositivity rate of Mumps(42 days)
- Seropositivity rate of Rubella(42 days)
- Geometric mean concentration (GMC) of Mumps(42 days)