A Phase 3, Multicenter, Randomized, Controlled Trial to Evaluate Immune Equivalence and Safety of Multidose and Single-dose Formulations of Vi-DT Typhoid Conjugate Vaccine in Healthy Filipino Individuals 6 Months to 45 Years of Age.

ABSTRACT:

Trial design

Phase 3, randomized, controlled, multicenter, equivalence trial.

Methods

Recruitment of participants occurred between 04Februray2020 and 15July2020 at four centers in the Philippines: University of the East - Ramon Magsaysay Memorial Medical Center Inc., Quezon City; University of Philippines Manila - National Institute of Health, Ermita Manila; Asian Hospital and Medical Center, Metro Manila, Philippines Study; and Medical Research Unit, Tropical Disease Foundation, Makati City, Metro Manila, Philippines.

Participants

1800 adults and children 6-months to 45-years of age.

Interventions

Participants received a single injection of multidose (MD) or single dose (SD) Vi-DT as test vaccines or meningococcal conjugate vaccine as a comparator.

Objectiv

SUBMITTER: Carlos JC 

PROVIDER: S-EPMC9160840 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature