Vaccine
Conditions
Keywords
Vi-DT Typhoid Conjugate Vaccine
Brief summary
Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.
Detailed description
This study will be done to know the long-term protection and persistent antibody, by measured the antibody titer after 2,3,4 and 5 years after immunization.
Interventions
Typhoid Conjugate Vaccine
Sponsors
Indonesia University
PT Bio Farma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
One dose Vi-DT vaccine in clinical trial subjects which is received primary dose at 6-23 months old.
Eligibility
Sex/Gender
ALL
Age
6 Months to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy. * Subject who completed the phase II Vi-DT study (Typhoid 0218) * Subjects/Parents have been informed properly regarding the study and signed the informed consent form. * Subject/parents/legal guardians will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion criteria
* Subject concomitantly enrolled or scheduled to be enrolled in another trial. * Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5oC). * Known history of allergy to any component of the vaccines. * History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. * Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants | 2 years + 2 months after primary dose | Percentage of adults, adolescent, children and infants with seroconversion defined as \>= 4 fold in antibody titer of anti Vi IgG 2 years after vaccination compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate immunogenicity one month after booster dose of Vi-DT in subject aged 6-23 months when receiving the primary dose. | 28 days (-4/+14D) | Percentage of subject aged 6-23 months old at primary dose with seroconversion defined as \>= 4 fold in antibody titer 28 days after booster dose compared to pre booster dose. |
| To assess the safety following booster vaccination in subject aged 6-23 months when receiving the primary dose. | 28 days (-4/+14D) | Percentage of subject with at least one adverse event, solicited or unsolicited, within 30 minutes, 72hours, 7 days and 28 days after booster dose. |
| To evaluate antibody persistence 3, 4 and 5 years after vaccination with one dose of Vi-DT in adults, adolescents, and children groups. | 5 years | Percentage of adults, adolescents and children with seroconversion defined as ≥ 4-fold in antibody titer of anti-Vi IgG 3,4 and 5 years after vaccination compared to baseline. |
| To evaluate antibody persistence 1, 2 and 3 years after booster vaccination in subject aged 6-23 months when receiving the primary dose. | 3 years | Percentage of adults, adolescents and children with seroconversion defined as ≥ 4-fold in antibody titer of anti-Vi IgG 3,4 and 5 years after vaccination compared to before booster. |
Countries
Indonesia
Outcome results
None listed