Phase III, Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Evaluate Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of OCV-S Compared to Shanchol™ in 1 to 40 Years Old Healthy Nepalese Participants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,530
- 试验地点
- 4
- 主要终点
- Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rates for all ages
研究概览
简要总结
This study is to evaluate immune non-inferiority, safety and lot-to-lot consistency of OCV-S compared to Shanchol™ in 1 to 40 years old healthy Nepalese participants. The investigators hypothesize that the simplified formulation is able to induce non-inferior immunogenicity compared to licensed OCV, Shanchol™.
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)
入排标准
- 年龄范围
- 1 Year 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants 1 to 40 years of age at enrollment
- •Participants/Parent(s)/Legally authorized representative (LAR) willing to provide written informed consent to participate study voluntarily
- •Participants/Parent(s)/LAR who can be followed up during the study period and can comply with the study requirements
排除标准
- •Known history of hypersensitivity reactions to other preventive vaccines
- •Severe chronic diseases or medical conditions based on the medical judgment of the investigator. In particular, a participant with a) chronic infection such as tuberculosis, or sequel of poliomyelitis, b) known history of immune function disorders, c) chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone equivalent for periods exceeding 10 days)/cytotoxic drugs/immunosuppressants within past 6 weeks, d) active malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease-free for 5 years, e) Congestive heart failure, f) myocardial infarction within the previous 6 months, g) known HIV-infected patients, h) neurological and/or psychiatric disorder, or i) known history of uncontrolled coagulopathy or blood disorders
- •Participant who planned to or has received other vaccines from 1 month prior to test vaccination excluding a public health vaccination campaign due to an outbreak
- •Participant concomitantly enrolled or scheduled to be enrolled in another trial
- •Receipt of blood or blood-derived products in the past 3 months
- •Participant who has previously received a cholera vaccine
- •Any female participant who is lactating, pregnant or planning for pregnancy during study period
- •Participants planning to move from the study area before the end of study period
- •Employees or the family members of the OCV-S study sites
- •Temporary Contraindication:
- •Should a participant have one of the conditions/situations listed below, the Investigator will postpone primary or subsequent vaccination until the condition/situation is resolved.
- •Febrile illness (axillary temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination or planned vaccination, according to Investigator's judgment.
- •Gastrointestinal symptoms including nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
- •Administration of antidiarrheal drugs or antibiotics to treat diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation
- •Diarrhea occurring up to 1 week within 6 months prior to study initiation.
- •Lactation: Breastfeeding women will not be enrolled. Should a female participant decide to breastfeed during the vaccination period, she will be excluded from further vaccination, but will be followed for safety until the end of the study
- •Pregnancy Test is necessary for all married female participants of childbearing age.
研究组 & 干预措施
Shanchol™ group
Participants (n=935) aged 1-40 years old will received Shanchol™ according to 0-2 week schedule.
干预措施: Shanchol™ (Biological)
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 1)
Participants (n=330) aged 18-40 years old will received OCV-S (Lot 1) according to 0-2 week schedule.
干预措施: Oral Cholera Vaccine Simplified (OCV-S) (Biological)
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 3)
Participants (n=935) aged 1-40 years old will received OCV-S (Lot 3) according to 0-2 week schedule.
干预措施: Oral Cholera Vaccine Simplified (OCV-S) (Biological)
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 2)
Participants (n=330) aged 18-40 years old will received OCV-S (Lot 2) according to 0-2 week schedule.
干预措施: Oral Cholera Vaccine Simplified (OCV-S) (Biological)
结局指标
主要结局
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rates for all ages
时间窗: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
Proportion of participants showing seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and O1 Ogawa 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™ for all ages
Vaccine Safety profile
时间窗: As in Description
Frequency of solicited adverse events within 7 days post vaccination, unsolicited adverse events within 28 days post vaccination, Serious Adverse Events (SAEs) after each dose during the entire study period in all ages and in each age stratum
次要结局
- Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rate in each age stratum(2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™)
- Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT for all ages(2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™)
- Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT in each age stratum(2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™)
- The equivalence of immunogenicity in 3 lots as measured by GMT(2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™)