Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants

Safety Issues Clinical Trial

Official title: Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian Adults, Adolescents, Children and Infants (Phase II)

Status Completed

Clinical Trial Summary

This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.

Clinical Trial Description

To describe the safety of this vaccine following one dose immunization in adults, adolescent, children and infants.

To assess immunogenicity following one dose of Vi-DT vaccine immunization. To compare the safety and immunogenicity of Vi-DT to Vi polysaccharide vaccine in adults, adolescents, and children groups.

To compare the safety and immunogenicity of Vi-DT to IPV vaccine in infants groups.

Kinetics of Vi-specific IgG antibodies up to 6 months and 1 year after administration of 1 dose of vaccine.

To evaluate the safety and immunogenicity of Vi-DT co-administered with MR vaccine in infants (≥ 9months -23 months old).

To evaluate the safety and immunogenicity of MR vaccine co-administered with Vi-DT vaccine in infants (≥ 9months -23 months old). ;

Related Conditions & MeSH terms

• Immunogenicity
• Safety Issues
• Typhoid Fever

• NCT number: NCT03460405
• Study type: Interventional
• Source: PT Bio Farma
• Status: Completed
• Phase: Phase 2
• Start date: July 16, 2018
• Completion date: January 30, 2020