One-month follow up of a randomized clinical trial-phase II study in 6 to  | Zendy

Bernie Endyarni Medise | Zendy; Soedjatmiko Soedjatmiko | Zendy; Hartono Gunardi | Zendy; Rini Sekartini | Zendy; Hindra Irawan Satari | Zendy; Sri Rezeki Hadinegoro | Zendy; Angga Wirahmadi | Zendy; Mita Puspita | Zendy; Rini Mulia Sari | Zendy; Jae Seung Yang | Zendy; Arijit Sil | Zendy; Sushant Sahastrabuddhe | Zendy; Novilia Sjafri Bachtiar | Zendy

Open Access

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

Author(s) -

Bernie Endyarni Medise,

Soedjatmiko Soedjatmiko,

Hartono Gunardi,

Rini Sekartini,

Hindra Irawan Satari,

Sri Rezeki Hadinegoro,

Angga Wirahmadi,

Mita Puspita,

Rini Mulia Sari,

Jae Seung Yang,

Arijit Sil,

Sushant Sahastrabuddhe,

Novilia Sjafri Bachtiar

Publication year - 2020

Publication title -

international journal of infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.278

H-Index - 89

eISSN - 1878-3511

pISSN - 1201-9712

DOI - 10.1016/j.ijid.2020.01.045

Subject(s) - medicine , typhoid fever , vaccination , conjugate vaccine , immunogenicity , seroconversion , adverse effect , typhoid vaccine , randomized controlled trial , immunology , pediatrics , antibody , virology

World Health Organization estimates the annual global incidence of typhoid fever at 11-21 million cases and approximately 128 000 to 161 000 deaths. The currently used Vi-polysaccharides (Vi-PS) vaccines have been proven to be safe and efficacious in children 2 years and above. However, poor immunogenicity of Vi-PS was observed in children below 2 years of age. This Phase II study is the continuation of the previously published Phase I study that aims to evaluate the safety and immunogenicity of a novel Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in subjects 6 to <24 months.

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