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| Name | Class |
|---|---|
| SK Bioscience Co., Ltd. | INDUSTRY |
| Bill and Melinda Gates Foundation | OTHER |
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This is a multicenter, randomized, observer-blinded, controlled, immune equivalence study of a multi-dose (MD) formulation with 2PE preservative of SK bioscience Vi-DT compared to single dose (SD) formulation without preservative of SK bioscience Vi-DT in participant (6 months - 45 years) including safety population.
The study objectives are as follows:
There are total 5 scheduled visits as follows:
The vaccines will be administered to 1,500 healthy participants of 6 months to 45 years of age and followed up for 24 weeks after the injection for safety. Adult participants (N=500) will be followed up for immunogenicity at 4 weeks and all participants till 24 weeks for safety post single dose of either MD & SD formulations. 300 healthy participants will be given control vaccine (locally available licensed Meningococcal conjugate vaccine) to check the background safety events. The primary objective is to demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT titer at 4 weeks after a single dose of MD/SD formulation in adults. The secondary objective is to demonstrate the equivalence of immunogenicity in terms of seroconversion rates as measured by anti-Vi IgG ELISA antibody titers, at 4 weeks after a single dose of MD/SD formulation in adults. A descriptive evaluation of safety at 4 and 24 weeks post single dose of (SD/MD/Meningococcal vaccine), will be performed. The Vi-DT vaccine from both MD & SD formulations will be administered as a single dose of 25 µg/0.5 mL.
Eligible participants enrolled into the study will be randomized into one of the three study groups within each age stratum of 6 months to less than 2 years, 2 to less than 18 years, and 18 to 45 years. Participants will be observed at the study site for 30 minutes after vaccination for safety assessment. Solicited adverse events will be recorded on a diary card during 7 days after vaccination. Unsolicited adverse events will be recorded during the 4 weeks after vaccination. Serious adverse events will be recorded during the entire study period. With the exception of designated study site personnel responsible for vaccine administration, site investigators, study nurse, and those assessing clinical outcomes, and data analysts will be blinded to vaccine allocation until data base lock for the final analysis.
Blood samples will be collected at baseline prior to vaccination and at 4 weeks post vaccination from adults (18-45 years) for immunogenicity assessment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vi-DT Multi-dose | Experimental |
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| Vi-DT Single-dose | Experimental |
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| Control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vi-DT (Multi-dose formulation) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMT) of anti-Vi IgG | If the 95% confidence interval of the ratio of GMT estimate of Vi-DT(MD) over GMT of Vi-DT(SD) is located within the bounds of 0.67to 1.5, then Vi-DT (MD) is equivalent to Vi-DT (SD) in terms of GMT of anti-Vi IgG with significance level of 0.05. | At 4 weeks (28 days) post vaccination of Vi-DT (MD/SD) |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rates of anti-Vi IgG ELISA antibody titres | If the 95% confidence interval of the estimate of difference of seroconversion rate between Vi-DT (MD) and Vi-DT (SD) at 4 weeks (Day 28) is located within the bounds -10% to 10%, then Vi-DT (MD) is equivalent to Vi-DT (SD) in terms of sero-conversion rate, which is defined as 4 fold increase of anti Vi IgG from baseline with significance level of 0.05. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints by each formulation and overall and within each age stratum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josefina C Carlos, MD | University of the East-Ramon Magsaysay Memorial Medical Center Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lingga Health Research Center | Calamba | Laguna | 4027 | Philippines | ||
| Magcase Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35664443 | Derived | Carlos JC, Tadesse BT, Borja-Tabora C, Alberto E, Ylade MC, Sil A, Kim DR, Ahn HS, Yang JS, Lee JY, Kim MS, Park J, Kwon SY, Kim H, Yang SY, Ryu JH, Park H, Shin JH, Lee Y, Kim JH, Mojares ZR, Wartel TA, Sahastrabuddhe S. A Phase 3, Multicenter, Randomized, Controlled Trial to Evaluate Immune Equivalence and Safety of Multidose and Single-dose Formulations of Vi-DT Typhoid Conjugate Vaccine in Healthy Filipino Individuals 6 Months to 45 Years of Age. Lancet Reg Health West Pac. 2022 May 30;24:100484. doi: 10.1016/j.lanwpc.2022.100484. eCollection 2022 Jul. |
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Participants age 6 months to 45 years
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This study is observer blind:
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| Vi-DT (Single dose formulation) | Biological |
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| Control Vaccine | Biological |
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| At 4 weeks (28 days) from baseline (Day 0; before vaccination of Vi-DT (MD/SD) |
| Solicited AEs during the 7 days after vaccination/Unsolicited AEs during 4 weeks (28 days) after vaccination/SAEs during the entire study period |
| San Pablo |
| Laguna |
| 4000 |
| Philippines |
| Putatan Research Center | Muntinlupa | National Capital Region | 1772 | Philippines |
| University of the Philippines Manila-National Institutes of Health | Manila | 1000 | Philippines |
| ID | Term |
|---|---|
| D014435 | Typhoid Fever |
| ID | Term |
|---|---|
| D012480 | Salmonella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004168 | Diphtheria Toxoid |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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