NCT03460405

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 6 Months – 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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).

Conditions

• Safety Issues
• Immunogenicity

Interventions

Type	Name	Description
BIOLOGICAL	Vi-DT Vaccine	1 dose of Vi-DT Vaccine
BIOLOGICAL	Vi Polysaccharide Vaccine	1 dose of Vi Polysaccharide Vaccine
BIOLOGICAL	IPV Vaccine	1 dose of IPV Vaccine

Timeline

• Start date: 2018-07-16
• Primary completion: 2019-12-31
• Completion: 2020-01-30
• First posted: 2018-03-09
• Last updated: 2020-02-20

Locations

2 sites across 1 country: Indonesia