Safety Issues, Immunogenicity
Conditions
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).
Interventions
BIOLOGICALVi-DT Vaccine
1 dose of Vi-DT Vaccine
BIOLOGICALVi Polysaccharide Vaccine
1 dose of Vi Polysaccharide Vaccine
BIOLOGICALIPV Vaccine
1 dose of IPV Vaccine
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Subject aged 2 - 40 years old: Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine. Subject 6-23 months old: Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).
Intervention model description
Subject aged 2 - 40 years old: Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine. Subject aged 6-23 months old: Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).
Eligibility
Sex/Gender
ALL
Age
6 Months to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy 2. Subjects/Parents have been informed properly regarding the study and signed the informed consent form 3. 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: 1. Subject concomitantly enrolled or scheduled to be enrolled in another trial 2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) 3. Known history of allergy to any component of the vaccines 4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection 5. 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). 6. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives 7. Pregnancy & lactation (Adults) 8. Individuals who have previously received any vaccines against typhoid fever. 9. Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization. 10. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization. 11. History of substance abuse (Adults). 12. Subject planning to move from the study area before the end of study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local reaction and systemic event after vaccination | 28 days | Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events after vaccination | up to 28 days | 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. |
| Serious adverse events after vaccination | 28 days | Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination |
| Geometric Mean Titers (GMT) | 28 days | Geometric Mean Titers (GMT) 28 days following immunization |
| Percentage of subjects with increasing antibody titer >= 4 times | 28 days | Percentage of subjects with increasing antibody titer \>= 4 times in all subjects |
Countries
Indonesia
Outcome results
None listed