Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
RSCM/UI
No Registry
INA-AB1DBOS
Tanggal Input Registry : 12-07-2018

17-04-2017
The main evaluation criteria are number and percentage of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after vaccination.
• Number and 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. • 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. • Any deviation from routine laboratory evaluation that probably related to the vaccination. • Description of safety data between groups
 
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
Observasional
2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine
100
 

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. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 60 days following the first dose. 10. Individuals who have a previously ascertained or suspected typhoid fever within 3 months prior to immunization. 11. History of alcohol or substance abuse. 12. Subject planning to move from the study area before the end of study period.
 
1015/UN2.F1/ETIK/2016
NA
PN.01.06.313.3.03.17.1449
Typhoid0116
Bernie Endyarni Medise, dr., SpA(K), MPH.