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
| Name | Class |
|---|---|
| SK Chemicals Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a Phase I, Randomized, observer-blinded, age de-escalating study.
The study objectives are:
This study will be carried out in healthy adults and children at a single site. Subjects will be stratified according to age.
The study procedure is as follows:
Visit 1 (day-1 to -7): Screen participants by medical history, physical examination and lab investigations. Collect blood for safety and immunogenicity assessments.
Visit 2 (day 0): Enroll, randomize and administer first dose of vaccine to eligible participants
Visit 3 (day 3): Assess participant safety by medical history and physical examination
Visit 4 (day 7): Record solicited adverse reaction 7 days post vaccination, and collect blood for safety lab assessments.
Visit 5 (day 28): Assess participant safety, collect blood for immunogenicity assessments, and administer second vaccine dose
Visit 6 (day 31): Participants safety will be assessed by medical history and physical examination
Visit 7 (day 35): Record solicited adverse reaction 7 days post second vaccination.
Visit 8 (day 56): Collect blood for immunogenicity assessments, assess participant safety, and fill in study completion form in the absence of any safety concern.
This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Two doses of Vi-DT (typhoid conjugate vaccine) will be administrated intramuscularly 4 weeks apart (Day 0 and Day 28). |
|
| Comparator group | Active Comparator | Biological/Vaccine: One dose of Typhim Vi® will be administrated intramuscularly at 1st dose (Day 0). One dose of VAXIGRIP® will be administrated intramuscularly at 2nd dose (Day 28). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vi-DT | Biological | Manufacturer: SK Chemicals Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints for solicited adverse events (reactogenicity) and serious adverse events | Proportion of participants with local and systemic solicited adverse events (reactogenicity) and Proportion of participant with Serious Adverse Events (SAEs) | 4 weeks post first and second vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with sero-conversion | Defined as a four-fold rise in anti-Vi antibody titers compared to baseline measured by anti-Vi IgG ELISA and Serum Bactericidal Assay | 4 weeks post first and second injections of Vi-DT and one injection of Vipolysaccharide |
| Geometric Mean Titers (GMT) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria Rosario Capeding, MD | Research Institution for Tropical Medicine | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29776750 | Derived | Capeding MR, Teshome S, Saluja T, Syed KA, Kim DR, Park JY, Yang JS, Kim YH, Park J, Jo SK, Chon Y, Kothari S, Yang SY, Ham DS, Ryu JH, Hwang HS, Mun JH, Lynch JA, Kim JH, Kim H, Excler JL, Sahastrabuddhe S. Safety and immunogenicity of a Vi-DT typhoid conjugate vaccine: Phase I trial in Healthy Filipino adults and children. Vaccine. 2018 Jun 18;36(26):3794-3801. doi: 10.1016/j.vaccine.2018.05.038. |
| Label | URL |
|---|---|
| Final Result | View source |
Not provided
Not provided
Not provided
Not provided
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
| ID | Term |
|---|---|
| C057664 | Vi polysaccharide vaccine, typhoid |
| C478242 | vaxigrip |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Laboratory personnel who analyzes immunogenicity at sponsor is also blinded.
| Typhim Vi® | Biological | Manufacturer: Sanofi Pasteur Ingredient: Purified Vi-polysaccharide Appearance: colourless liquid Dose: 0.5mL/vial |
|
| VAXIGRIP® | Biological | Dose: Single injection, participants 6-35 months of age will receive 0.25 ml (half a dose), participants 36 months of age and older will receive 0.5ml (full dose) *Participants less than 9 years of age, who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after the last follow-up visit of last participant in their age cohort. |
|
Measurement of the Geometric Mean Titers (GMT) following 4 weeks post first and second injections of Vi-DT and one injection of Vi-polysaccharide vaccine |
| 4 weeks post first and second vaccination |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |