immune non-inferiority, safety and lot-to-lot consistency of oral cholera vaccine-simplified compared to shanchol™

Conditions: Cholera

Summary: 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™.


Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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.