Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian Adults, Adolescents, Children and Infants (Phase II)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Safety Issues
- Sponsor
- PT Bio Farma
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Local reaction and systemic event after vaccination
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects/Parents have been informed properly regarding the study and signed the informed consent form
- •Subject/parents/legal guardians will commit themselves to comply with the instructions of the investigator and the schedule of the trial.
- •Exclusion Criteria For adults-adolescent-children:
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)
- •Known history of allergy to any component of the vaccines
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- •Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, corticosteroid therapy and other immunosuppresant).
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
- •Pregnancy \& lactation (Adults)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Local reaction and systemic event after vaccination
Time Frame: 28 days
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.
Secondary Outcomes
- Adverse events after vaccination(up to 28 days)
- Serious adverse events after vaccination(28 days)
- Geometric Mean Titers (GMT)(28 days)
- Percentage of subjects with increasing antibody titer >= 4 times(28 days)