A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,040
- 主要终点
- Number of Participants With Any Severity of Rotavirus Gastroenteritis
研究概览
简要总结
This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine [OPV] and diphtheria, tetanus, and acellular pertussis vaccine [DTaP]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants at least 6 weeks (42 days) and up to 12 weeks (84 days) of age at the time of the first study vaccination
- •Parent/legal guardian agrees to participate by giving written informed consent and is willing and able to comply with study requirements
排除标准
- •History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
- •History of intussusception
- •Impairment of immunological function, including Severe Combined Immunodeficiency (SCID)
- •Acute disease, severe chronic disease, or chronic disease during the acute period
- •Uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological disease
- •Hypersensitivity to any component of the rotavirus vaccine, OPV, or DTaP
- •Prior receipt of any rotavirus vaccine
- •Fever, with an axillary temperature >=37.5 °C (or equivalent) within 24 hours before study vaccination (study vaccination can be deferred until complete resolution of febrile illness)
- •Clinical evidence of active gastrointestinal illness
- •Received intramuscular, oral, or intravenous corticosteroid treatment since birth (topical, ophthalmic, and inhaled steroids are permitted)
- •Resides in a household with an immunocompromised person
- •Receipt of a blood transfusion or blood products, including immunoglobulins
- •Participation in another interventional study within 14 days before the first study vaccination or during the study
- •Receipt of an investigational or non-registered product other than the study vaccine within 30 days before the first study vaccination or during the study
- •For participants in immunogenicity arms: inability to obtain a blood specimen at randomization visit (note: the visit may be rescheduled so that a baseline specimen may be obtained); history of polio, diphtheria, tetanus, or pertussis disease; previous vaccination against diphtheria, tetanus, pertussis, or poliomyelitis
- •Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives
结局指标
主要结局
Number of Participants With Any Severity of Rotavirus Gastroenteritis
时间窗: From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)
The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms.
次要结局
- Percentage of Participants With Elevated Temperature(Up to 30 days after any dose of V260 or Placebo)
- Percentage of Participants With Vomiting or Diarrhea(Up to 30 days after any dose of V260 or Placebo)
- Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3(Baseline and between 28 and 56 days after the third OPV vaccination)
- Percentage of Participants With Intussusception(Up to 15 months)
- Percentage of Participants With Any Adverse Event(Up to 30 days after any dose of V260 or Placebo)
- Number of Participants With Severe Rotavirus Gastroenteritis(From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months))
- Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens(Baseline and between 28 and 51 days after the third DTaP vaccination)