A Phase III, open label, multicenter, parallel group, randomized Clinical Study to compare the Immunogenicity and Safety of Euvichol-Plus vaccine with Oral Cholera Vaccine Shanchol in healthy adults and children above age of one year
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 9
- 主要终点
- Assessment of seroconversion rate :The proportion of subjects with at least 4 times higher anti-V. cholerae O1 Ogawa and Inaba antibody titer
研究概览
简要总结
Cholera is a significant public health problem in many developing countries. The WHO recommends immunization with cholera vaccines as the complementary management strategy. This study is related to a bivalent (O1 and O139) inactivated whole cell Oral Cholera Vaccine (OCV) containing killed whole cells of Vibrio cholerae O1 and Vibrio cholerae O139. A two-dose regimen of this vaccine was shown to be well-tolerated and immunogenic against Vibrio cholerae. This will be carried out in healthy adults and children. Randomization will be stratified according to age 18 years to 60 years, 1 to <18 years. According to the pre-generated randomization table, the subjects will be randomized to the test and comparator groups (Visit 1) and will be given either the test vaccine or the comparator vaccine. For immunogenicity assessment, the blood sample will be taken at Visit 1 (prior to investigational product dosing), Visit 2 (prior to investigational product dosing), and Visit 3 (after two weeks of the second dose). At both follow up telephonic visits after vaccination, the appointed field officer will contact subjects via telephone for 3 consecutive days after the dosing of the vaccine. For safety assessment, the subjects and/or parents/legally acceptable representatives will be instructed to record on the subject diaries adverse events that occur after investigational product dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Individuals aged 1 year to 60 years both inclusive 2.Voluntary written informed consent form for study participation provided by an individual or his/her legally acceptable representative.
- •Subjects aged 12 to <18 years, must sign an assent for the study and a parent or a legal guardian have to sign the informed consent.
- •Subject aged 7 to 11 years need to provide an oral consent/assent and the consent form must be signed by parent/legally acceptable representative.
- •Less than 7 years no need of assent, LAR can give consent 3.An individual who can be followed up during the study period and is capable of complying with the study requirements.
- •4.Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the investigator.
排除标准
- •1.History of cholera vaccinations or history of cholera.
- •2.History of hypersensitivity reactions to other preventative vaccinations.
- •3.Immune function disorders including immunodeficiency diseases.
- •4.38℃ or higher body temperature measured prior to investigational product dosing.
- •5.Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.
- •Also, administration of antidiarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
- •7.Pregnant or lactating women should be excluded by performing urine pregnancy test during screening.
- •8.Children vaccinated within 1 month prior to study initiation or planned vaccination during the study.
- •9.Participants in another clinical trial with investigational product dosing within 6 months prior to study initiation.
- •10.An individual thought to have difficulty in participating the study due to severe chronic diseases, based on the judgment of the investigator.
- •11.An individual thought to have difficulty in participating the study due to other reasons, based on the judgment of the investigator 12.If female patient will get pregnant after first vaccination.
结局指标
主要结局
Assessment of seroconversion rate :The proportion of subjects with at least 4 times higher anti-V. cholerae O1 Ogawa and Inaba antibody titer
时间窗: 2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1).
次要结局
- •Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by anti-V. Cholerae O139 antibody titer(2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1).)
- Assessment of seroconversion rate: The proportion of subjects with at least 4 times higher anti-V. cholerae O139 antibody titer(2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1))
- •Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by anti-V. Cholerae O1 Ogawa and Inaba antibody titer(2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1).)