A Phase III Randomized, Double-Blind, Controlled Trial of the Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi

HP-00076625

This study will evaluate the efficacy of a Typhoid conjugate vaccine (Vi-TCV) in Malawi, Africa among children age 9 months through 12 years. Participants will be randomized in a 1:1 ration to receive the study vaccine or the control vaccine (meningococcal group A conjugate vaccine - MCV-A).

2018-02-21

2024-10-30

2025-10-30

Active (not recruiting)

Early phase I

30000

Inclusion Criteria: * Healthy male or female child between the ages of 9 months and 12 years/364 days at the time of study vaccination. * A child whose parent or guardian resides primarily within the Ndirande or Zingwangwa study areas at the time of study vaccinations and who intends to be present in the area for the duration of the trial. * A child whose parent or guardian has voluntarily given informed consent. Exclusion Criteria: * History of documented hypersensitivity to any component of the vaccine * Prior receipt of any typhoid vaccine in the past 3 years * History of severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis * Any condition determined by the investigator to be likely to interfere with evaluation of the vaccine or to be a significant potential health risk to the child or make it unlikely that the child would complete the study. Temporary Exclusion Criteria: The following will be considered temporary contraindications to enrollment and vaccination. If these apply, the participant will be temporarily excluded for vaccination until 48 hours has passed. A re-assessment will be needed to ensure these temporary exclusion criteria no longer exist. * Reported fever within 24 hours prior to vaccination * Use of anti-pyretics within 4 hours prior to vaccination An additional temporary exclusion criteria will be: - Receipt of measles vaccine in the one month prior to enrollment, as determined by parental history or vaccination card. Additional Exclusion Criteria for Safety and Immunogenicity Substudy: In addition to the exclusion criteria of the efficacy study, participants enrolled in the immunogenicity and reactogenicity substudy may not have, or have had, any: * Known history of diabetes, tuberculosis, cancer, chronic kidney, heart, or liver disease, progressive neurological disorders, poorly controlled seizures, or terminal illness * Severe malnutrition as determined by MUAC\< 12.5 cm for children younger than 5 years; * Receipt of any other investigational intervention in the last 6 months or anticipated during the course of the study. * Receipt of blood products in the last 6 months. * Known HIV-infection or exposure or other immunosuppressive conditions. * Receipt of systemic immunosuppressant or systemic corticosteroids. * Receipt of any measles-containing vaccine for children younger than 1 year of age

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2024-03-15