Safety Issues Clinical Trial
Official title:
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian Adults, Adolescents, Children and Infants (Phase II)
Verified date | February 2020 |
Source | PT Bio Farma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
Status | Completed |
Enrollment | 600 |
Est. completion date | January 30, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 40 Years |
Eligibility |
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. Exclusion Criteria for infants: 1. Subject concomitantly enrolled or scheduled to be enrolled in another trial 2. Mother less than 18 years of age at the age of enrollment of the infant 3. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) 4. Known history of allergy to any component of the vaccines 5. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection 6. 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). 7. 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. 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, except MR vaccine. 10. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization. 11. Subject planning to move from the study area before the end of study period. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Puskesmas Jatinegara | Jakarta | |
Indonesia | Puskesmas Senen | Jakarta |
Lead Sponsor | Collaborator |
---|---|
PT Bio Farma |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local reaction and systemic event after vaccination | Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination. | 28 days | |
Secondary | Adverse events after vaccination | 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. | up to 28 days | |
Secondary | Serious adverse events after vaccination | Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination | 28 days | |
Secondary | Geometric Mean Titers (GMT) | Geometric Mean Titers (GMT) 28 days following immunization | 28 days | |
Secondary | Percentage of subjects with increasing antibody titer >= 4 times | Percentage of subjects with increasing antibody titer >= 4 times in all subjects | 28 days |
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