A Phase II, Randomized, Dose-scheduling, Observer-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of Vi-DT Conjugate Vaccine in 6-23-Month Old Healthy Filipino Infants and Toddlers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 2
- 主要终点
- Safety endpoints: solicited and unsolicited adverse events and serious adverse events
研究概览
简要总结
This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose.
The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age.
The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6 months apart.
详细描述
This study is carried out in healthy children aged 6 to 23 months at a single site. A total of 285 participants are enrolled, 114, 114 and 57 participants are randomized to either the single dose, two-dose Vi-DT regimens or placebo/comparator group, respectively within age strata. Three age strata is 6 to less than 9 months, 9 to 12 months and 13 to 23 months. The investigators allow the 9-12 months old children to receive Measles-Mumps-Rubella (MMR) vaccine concomitantly with Vi-DT vaccine and descriptive analysis of immune response to MMR only and to MMR and Vi-DT vaccines are performed to assess the possible immunological interference with MMR vaccine.
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
Observer Blinded
入排标准
- 年龄范围
- 6 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants and children 6-23 months of age at enrollment as determined by medical history, physical examination and clinical judgment of the investigator
- •Birth weight ≥ 2500 g
- •≥ 37 weeks of pregnancy or judge to be full-term by the midwife or birth attendant
- •Parents aged 18 years and above and legal guardians aged 21 years and above as per the legal authorization in the Philippines, who have voluntarily given informed consent
- •Parents/ legal guardians willing to follow the study procedures of the study and available for the entire duration of the study
排除标准
- •Child with a congenital abnormality
- •Subject with abnormal routine biological values at screening
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial
- •Acute illness, in particular infectious disease or fever (axillary temperature ≥37.5°C), within three days prior to enrolment and vaccination
- •Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (>20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
- •Child with a previously ascertained or suspected disease caused by S. typhi
- •Child who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi
- •Known history or allergy to vaccines or other medications
- •Know history of allergy to eggs, chicken protein, neomycin and formaldehyde
- •History of uncontrolled coagulopathy or blood disorders
- •Mother has known HIV infection or other immune function disorders
- •Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the subject and interfere with the assessment of the study objectives
- •Child whose parents or legal guardian planning to move from the study area before the end of study period
结局指标
主要结局
Safety endpoints: solicited and unsolicited adverse events and serious adverse events
时间窗: Solicited AE: during 7 days after each vaccination. Unsolicited AE: after the first vaccination until 4 weeks after the second vaccination. SAE will be captured after the first vaccination up to week 100 for Group A, week 96 for Group B, week 36 Group C
* Frequency (percentage) of solicited local reactions at the injection site: Pain, tenderness, erythema/redness, swelling/induration and pruritus local * Frequency (percentage) of solicited systemic reactions: Fever, lethargy, irritability, vomiting, diarrhea, drowsiness, loss of appetite, persistent crying, rash and nasopharyngitis * Frequency (percentage) of unsolicited adverse events * Frequency (percentage) of serious adverse events
次要结局
- Immunogenicity Endpoints(At week 28, 4 weeks after the second vaccination)