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

IVI OCV-S

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™.

2021-10-06

2022-12-22

2023-03-21

Completed

Early phase I

2530

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2530, 'type': 'ACTUAL'}}

2023-06-22