Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Vi-CRM197, Batch #1) | Experimental | Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #1 will be intramuscularly administered at Day 0. |
|
| Arm A (Vi-CRM197, Batch #2) | Experimental | Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #2 will be intramuscularly administered at Day 0. |
|
| Arm A (Vi-CRM197, Batch #3) | Experimental | Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #3 will be intramuscularly administered at Day 0. |
|
| Arm D (Typbar-TCV) | Active Comparator | Single dose of Typhoid Conjugate Vaccine (Typbar-TCV) will be intramuscularly administered at Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EuTCV (Vi-CRM Typhoid conjugate vaccine) | Biological | Single dose, Intramuscular administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | 4 weeks after vaccination of EuTCV (pooled of 3 batches)/Typbar-TCV compared to baseline | |
| Proportion of Solicited local and systemic AEs | 7 days after vaccination | |
| Proportion of unsolicited AEs | within 28 days after vaccination |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| De La Salle Medical and Health Sciences Institute | Cavite | Philippines | ||||
| University of the East Ramon Magsaysay Memorial Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36774331 | Derived | Ok Baik Y, Lee Y, Lee C, Kyung Kim S, Park J, Sun M, Jung D, Young Jang J, Jun Yong T, Woo Park J, Jeong S, Lim S, Hyun Han S, Keun Choi S. A Phase II/III, Multicenter, Observer-blinded, Randomized, Non-inferiority and Safety, study of typhoid conjugate vaccine (EuTCV) compared to Typbar-TCV(R) in healthy 6 Months-45 years aged participants. Vaccine. 2023 Mar 3;41(10):1753-1759. doi: 10.1016/j.vaccine.2022.12.007. Epub 2023 Feb 9. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014435 | Typhoid Fever |
| ID | Term |
|---|---|
| D012480 | Salmonella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Typbar-TCV | Biological | Single dose, Intramuscular administration |
|
| Quezon City |
| Philippines |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |