This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
600
1 dose of Vi-DT Vaccine
1 dose of Vi Polysaccharide Vaccine
1 dose of IPV Vaccine
Puskesmas Jatinegara
Jakarta, Indonesia
Puskesmas Senen
Jakarta, Indonesia
Local reaction and systemic event after vaccination
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.
Time frame: 28 days
Adverse events after vaccination
Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after 1 dose vaccination.
Time frame: up to 28 days
Serious adverse events after vaccination
Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination
Time frame: 28 days
Geometric Mean Titers (GMT)
Geometric Mean Titers (GMT) 28 days following immunization
Time frame: 28 days
Percentage of subjects with increasing antibody titer >= 4 times
Percentage of subjects with increasing antibody titer \>= 4 times in all subjects
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.