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™.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,530
* Manufacturer: EuBiologics Co., Ltd. * Oral administration
* Manufacturer: Shantha Biotechnics * Oral administration
Nepalgunj medical college
Bānke, City- Nepalgunj, Nepal
B.P.Koirala Institute of Health Sciences
Rautahat, Dharan, Nepal
Dhulikhel Hospital
Kavre, Dhulikhel, Nepal
Kanti Children's Hospital
Kathmandu, Sukedhara, Nepal
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rates for all ages
Proportion of participants showing seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and O1 Ogawa 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™ for all ages
Time frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
Vaccine Safety profile
Frequency of solicited adverse events within 7 days post vaccination, unsolicited adverse events within 28 days post vaccination, Serious Adverse Events (SAEs) after each dose during the entire study period in all ages and in each age stratum
Time frame: As in Description
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT for all ages
Geometric Mean Titer (GMT) of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™ for all ages
Time frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rate in each age stratum
Proportion of participants showing seroconversion against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™ in each age stratum
Time frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT in each age stratum
Geometric Mean Titer of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™ in each age stratum
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Time frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
The equivalence of immunogenicity in 3 lots as measured by GMT
Geometric Mean Titer of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of 3 lots of OCV-S in adults
Time frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™