Safety Issues
Conditions
Brief summary
This study is to assess the safety of Vi-DT vaccine in adults and children.
Detailed description
To describe the safety of this vaccine following first and second dose immunization. To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.
Interventions
BIOLOGICALVi-DT (Bio Farma)
Typhoid Conjugate Vaccine
BIOLOGICALVi polysaccharide vaccine
Vi polysaccharide vaccine
BIOLOGICALInfluenzae vaccine
1 dose of Influenzae vaccine
BIOLOGICALPneumococcal conjugate vaccine
1 dose of Pneumococcal conjugate Vaccine
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years 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 will commit to comply with the instructions of the investigator and the schedule of the trial
Exclusion criteria
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 or long term corticotherapy (\> 2 weeks). 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 4 weeks prior and expect to receive other vaccines within 60 days following the first dose. 10. Individuals who have a previously ascertained typhoid fever. 11. History of alcohol or substance abuse. 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 | 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 each vaccination. |
| Serious adverse events after vaccination | 28 days | Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination and up to 6 months after the last vaccination. |
| Routine laboratory evaluation that probably related to the vaccination. | 7 days | Deviation from routine blood laboratory, kidney and liver function laboratory evaluation that probably related to the vaccination. |
| Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT) | 28 days | Percentage of subjects with \> 4 times increasing antibody |
| Geometric Mean Titers (GMT) following immunization | 28 days | Geometric Mean Titers (GMT) 28 days following immunization |
Countries
Indonesia
Outcome results
None listed