Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Comp… (NCT04760236) | Clinical Trial Compass
CompletedPhase 3
Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™
Nepal2,530 participantsStarted 2021-10-06
Plain-language 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™.
Who can participate
Age range1 Year – 40 Years
SexALL
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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 ex…
What they're measuring
1
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rates for all ages
Timeframe: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™