Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian Adults, Adolescents, Children and Infants (Phase II)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Local reaction and systemic event after vaccination
研究概览
简要总结
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
详细描述
To describe the safety of this vaccine following one dose immunization in adults, adolescent, children and infants.
To assess immunogenicity following one dose of Vi-DT vaccine immunization. To compare the safety and immunogenicity of Vi-DT to Vi polysaccharide vaccine in adults, adolescents, and children groups.
To compare the safety and immunogenicity of Vi-DT to IPV vaccine in infants groups.
Kinetics of Vi-specific IgG antibodies up to 6 months and 1 year after administration of 1 dose of vaccine.
To evaluate the safety and immunogenicity of Vi-DT co-administered with MR vaccine in infants (≥ 9months -23 months old).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Subject aged 2 - 40 years old:
Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine.
Subject 6-23 months old:
Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).
入排标准
- 年龄范围
- 6 Months 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects/Parents have been informed properly regarding the study and signed the informed consent form
- •Subject/parents/legal guardians will commit themselves to comply with the instructions of the investigator and the schedule of the trial.
- •Exclusion Criteria For adults-adolescent-children:
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
- •Known history of allergy to any component of the vaccines
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- •Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, corticosteroid therapy and other immunosuppresant).
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
- •Pregnancy & lactation (Adults)
- •Individuals who have previously received any vaccines against typhoid fever.
- •Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization.
- •Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
- •History of substance abuse (Adults).
- •Subject planning to move from the study area before the end of study period.
- •Exclusion Criteria for infants:
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial
- •Mother less than 18 years of age at the age of enrollment of the infant
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
- •Known history of allergy to any component of the vaccines
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- •Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, corticosteroid therapy and other immunosuppresant).
- •Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.
- •Individuals who have previously received any vaccines against typhoid fever.
- •Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization, except MR vaccine.
- •Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
- •Subject planning to move from the study area before the end of study period.
排除标准
- 未提供
结局指标
主要结局
Local reaction and systemic event after vaccination
时间窗: 28 days
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.
次要结局
- Adverse events after vaccination(up to 28 days)
- Serious adverse events after vaccination(28 days)
- Geometric Mean Titers (GMT)(28 days)
- Percentage of subjects with increasing antibody titer >= 4 times(28 days)