Typhoid Clinical Trial
Official title:
A Phase II, Randomized, Dose-scheduling, Observer-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of Vi-DT Conjugate Vaccine in 6-23-Month Old Healthy Filipino Infants and Toddlers
This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose. The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age. The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6 months apart.
This study is carried out in healthy children aged 6 to 23 months at a single site. A total of 285 participants are enrolled, 114, 114 and 57 participants are randomized to either the single dose, two-dose Vi-DT regimens or placebo/comparator group, respectively within age strata. Three age strata is 6 to less than 9 months, 9 to 12 months and 13 to 23 months. The investigators allow the 9-12 months old children to receive Measles-Mumps-Rubella (MMR) vaccine concomitantly with Vi-DT vaccine and descriptive analysis of immune response to MMR only and to MMR and Vi-DT vaccines are performed to assess the possible immunological interference with MMR vaccine. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03312699 -
Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort
|
Phase 1 | |
Completed |
NCT01405521 -
Understanding Typhoid Disease After Vaccination
|
Phase 2 | |
Completed |
NCT00131833 -
Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China
|
Phase 4 | |
Completed |
NCT00125047 -
Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood
|
Phase 4 | |
Not yet recruiting |
NCT05771779 -
Co-administration Study of OCV, TCV and MR
|
Phase 3 | |
Completed |
NCT01466387 -
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
|
Phase 3 | |
Active, not recruiting |
NCT03933098 -
Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine
|
Phase 3 | |
Completed |
NCT00679172 -
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
|
Phase 2 | |
Completed |
NCT00125008 -
Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever
|
Phase 4 | |
Recruiting |
NCT04878549 -
Transcriptomic Responses for the Identification of Pathogens
|
||
Completed |
NCT02645032 -
Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine
|
Phase 1 | |
Recruiting |
NCT05475379 -
Non-inferiority Trial of Locally Manufactured Typhoid Conjugate Vaccine 'Typhocon' in Bangladesh
|
Phase 1/Phase 2 | |
Completed |
NCT04204096 -
Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III)
|
Phase 3 | |
Active, not recruiting |
NCT03299426 -
Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi
|
Phase 3 | |
Completed |
NCT01019083 -
Studies of Immune Responses to Orally Administered Vaccines in Developing Country
|
Phase 1/Phase 2 | |
Completed |
NCT03614533 -
Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso
|
Phase 2 | |
Completed |
NCT00131820 -
Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam
|
Phase 4 |