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GSK Biologicals' 208136, new formulation · 1 trial · 4 indications
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
| Arm | Type | Description |
|---|---|---|
| Priorix-Tetra new WS Group | EXPERIMENTAL | Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12. |
| Priorix-Tetra current WS Group | EXPERIMENTAL | Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12. |
| Name | Type | Description |
|---|---|---|
| Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine) | BIOLOGICAL | Vaccine will be administered subcutaneously in the left upper arm (deltoid region) |
| GSK Biologicals' 208136, new formulation | BIOLOGICAL | Vaccine will be administered subcutaneously in the left upper arm (deltoid region) |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. * A male or female between, and including, 11 and 21...
GSK Biologicals' 208136 new formulation is a vaccine being developed for measles, as well as varicella, mumps, and rubella. It is currently in Phase 2 clinical development and is intended for use in healthy volunteers, including children as young as 11 months.
GSK Biologicals' 208136 new formulation is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's immunogenicity and safety.
GSK Biologicals' 208136 new formulation is in Phase 2 clinical development. It is an investigational vaccine, meaning it has not yet been approved for public use. The Phase 2 trial has been completed, with results expected to inform further development.
GSK Biologicals' 208136 new formulation has one completed Phase 2 clinical trial, identified as NCT00892775. This study, titled "Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds," enrolled 501 participants in Singapore and Taiwan.
GSK Biologicals' 208136 new formulation is a distinct version of the 208136 vaccine, specifically reformulated with new measles and rubella working seeds. The clinical trial NCT00892775 was designed to evaluate the immunogenicity and safety of this new formulation compared to the original.