NCT03527355

Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: International Vaccine Institute · Academic / Other
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Typhoid

Interventions

Type	Name	Description
BIOLOGICAL	Vi-DT	Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial
BIOLOGICAL	FluQuadri™	Manufacturer: Sanofi Pasteur Dose: 0.25 ml \*Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding.
OTHER	0.9% sodium chloride isotonic solution	Manufacture: Euro-Med Inc. Dose: 0.5 mL

Timeline

• Start date: 2018-04-18
• Primary completion: 2018-07-28
• Completion: 2021-01-19
• First posted: 2018-05-17
• Last updated: 2021-08-27

Locations

1 site across 1 country: Philippines