drugset / Trial / NCT03460405
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
Timeline
- Start
- 2018-07-16
- Primary completion
- 2019-12-31
- Completion
- 2020-01-30
Publications
- Koesnoe S, Medise BE, Rengganis I, Hadinegoro SR, Puspita M, Sari RM, Yang JS, Sahastrabuddhe S, Soedjatmiko, Gunardi H, Sekartini R, Wirahmadi A, Kekalih A, Mukhi S, Satari HI, Bachtiar NS. A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity. Trop Dis Travel Med Vaccines. 2024 Feb 1;10(1):3. doi: 10.1186/s40794-023-00210-z.
- Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2-11 years: a phase II preliminary report. BMC Pediatr. 2020 Oct 15;20(1):480. doi: 10.1186/s12887-020-02375-4.
- Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. One-month follow up of a randomized clinical trial-phase II study in 6 to <24 months old Indonesian subjects: Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine. Int J Infect Dis. 2020 Apr;93:102-107. doi: 10.1016/j.ijid.2020.01.045. Epub 2020 Jan 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | IPV vaccine | Vaccine | 0.5 ml | — |
| Subject | Typhoid Conjugate vaccine | Vaccine | 0.5 ml | — |
| Comparator | Vi Polysaccharide Vaccine | Vaccine | 0.5 ml | — |
Indications
No indication recorded.