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

Techinvention lifecare Pvt Ltd0 个研究点目标入组 416 人开始时间: 待定最近更新: 2023年5月29日

试验速览

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•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

•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.
•4.38â?? 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.
•6.Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours 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

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