1,800
Participants
Start Date
February 4, 2020
Primary Completion Date
September 11, 2020
Study Completion Date
January 29, 2021
Vi-DT (Multi-dose formulation)
"* Manufacturer: SK bioscience Co., Ltd.~* Dose formulation: 25 µg Vi polysaccharide /0.5 mL, presented in Type I glass vial (multi dose Vi-DT with preservative 2 PE)~* Mode of Administration: 0.5 mL by intramuscular injection in the left anterolateral thigh or left arm deltoid region in participants below 2 years of age, less dominant arm deltoid region in age group 2 to 45 years~* Storage Conditions: +2 to +8°C"
Vi-DT (Single dose formulation)
"* Manufacturer: SK bioscience Co., Ltd.~* Dose formulation: 25 µg Vi polysaccharide /0.5 mL, presented in Type I glass vial (single dose Vi-DT without any preservative)~* Mode of Administration: 0.5 mL by intramuscular injection in the left anterolateral thigh or left arm deltoid region in participants below 2 years of age, less dominant arm deltoid region in age group 2-45 years~* Storage Conditions: +2 to +8°C"
Control Vaccine
"* For participant ≥ 1 year one dose of locally licensed Meningococcal conjugate vaccine will be administered~* For participants 6 months to 1 year one dose of locally licensed Meningococcal conjugate vaccine will be administered during the study and the next dose will be provided after the study unblinding at the completion of 6 months follow up of last subject."
University of the Philippines Manila-National Institutes of Health, Manila
Putatan Research Center, Muntinlupa
Magcase Health Center, San Pablo
Lingga Health Research Center, Calamba
SK Bioscience Co., Ltd.
INDUSTRY
Bill and Melinda Gates Foundation
OTHER
International Vaccine Institute
OTHER