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PriorixTetra · 1 trial · 4 indications
Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.
Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.
| Arm | Type | Description |
|---|---|---|
| Group A | ACTIVE_COMPARATOR | Subjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49). |
| Group B | EXPERIMENTAL | Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0). |
| Group C | ACTIVE_COMPARATOR | Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49). |
| Name | Type | Description |
|---|---|---|
| PriorixTetra™ | BIOLOGICAL | One dose administered subcutaneously |
| Meningitec | BIOLOGICAL | One dose administered intramuscularly |
Inclusion Criteria: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol. * A male or female between, and including, 13 and 15 months of age at the time of the first vaccination. * Written informed...
Priorix-Tetra is a vaccine used for the prevention of varicella (chickenpox) and rubella, as well as measles and mumps. It is being developed by GSK plc for use in children, with clinical trials evaluating its immunogenicity and safety in healthy pediatric populations.
Priorix-Tetra is a vaccine that targets the viruses causing varicella (chickenpox), rubella, measles, and mumps. It is designed to induce an immune response against these four viral diseases, providing protection through vaccination.
Priorix-Tetra is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's safety and efficacy in pediatric populations.
Priorix-Tetra has completed Phase 3 clinical trials, with two Phase 3 studies and one Phase 2 study finished. It is an investigational vaccine still in clinical development, and it is not yet approved by regulatory authorities.
Priorix-Tetra has been studied in completed clinical trials, including NCT00226499 (Phase 3, enrolling 5,803 children across multiple countries) and NCT01506193 (Phase 3, enrolling 716 children in Italy). A Phase 2 trial, NCT00578175, enrolled 1,851 children in the United States.
Priorix-Tetra is not the same as ProQuad, but it was compared against ProQuad in a clinical trial. The Phase 2 study NCT00578175 evaluated the immunogenicity and safety of GSK's MMRV vaccine versus ProQuad in children aged 12-14 months.