Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™
Cholera
About this trial
This is an interventional prevention trial for Cholera
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.
Sites / Locations
- Nepalgunj medical college
- B.P.Koirala Institute of Health Sciences
- Dhulikhel Hospital
- Kanti Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 1)
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 2)
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 3)
Shanchol™ group
Participants (n=330) aged 18-40 years old will received OCV-S (Lot 1) according to 0-2 week schedule.
Participants (n=330) aged 18-40 years old will received OCV-S (Lot 2) according to 0-2 week schedule.
Participants (n=935) aged 1-40 years old will received OCV-S (Lot 3) according to 0-2 week schedule.
Participants (n=935) aged 1-40 years old will received Shanchol™ according to 0-2 week schedule.