Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biological's investigational vaccine 209762 · 1 trial · 4 indications
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<150 mIU/mL prior to vaccination.
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<24 ED50 prior to vaccination.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
| Arm | Type | Description |
|---|---|---|
| Priorix 1 Group | EXPERIMENTAL | Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. |
| Priorix 2 Group | EXPERIMENTAL | Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. |
| Priorix 3 Group | EXPERIMENTAL | Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. |
| MMR-II Group | ACTIVE_COMPARATOR | Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. |
| Name | Type | Description |
|---|---|---|
| GSK Biological's investigational vaccine 209762 | BIOLOGICAL | Subcutaneous injection, one dose |
| M-M-R® II (Merck and Co) | BIOLOGICAL | Subcutaneous injection, one dose |
| Varivax® | BIOLOGICAL | Subcutaneous injection, one dose |
| Havrix® | BIOLOGICAL | Intramuscular injection, one dose |
| Prevnar® | BIOLOGICAL | Intramuscular injection, one dose |
Inclusion Criteria: * Subjects for whom the investigator believes 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. * Male or female between 12 and 15 months of age (e....
GSK Biological's investigational vaccine 209762 is a vaccine being developed for the prevention of rubella, as well as measles and mumps, as part of a measles-mumps-rubella (MMR) combination vaccine. It is currently in Phase 2 clinical development for use in infectious disease prevention.
GSK Biological's investigational vaccine 209762 is being developed by GSK plc, a biopharmaceutical company traded on the stock exchange under the ticker symbol GSK. The vaccine is currently in Phase 2 clinical development for the prevention of rubella, measles, and mumps.
GSK Biological's investigational vaccine 209762 is currently in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to evaluate its immunogenicity and safety.
GSK Biological's investigational vaccine 209762 has been studied in one completed Phase 2 clinical trial, identified as NCT00861744. This trial evaluated the immunogenicity of the vaccine compared to M-M-R II when given with routine vaccines to children aged 12 to 15 months in the United States and Puerto Rico.
GSK Biological's investigational vaccine 209762 is not the same as M-M-R II. It is an investigational measles-mumps-rubella (MMR) vaccine being developed by GSK. In clinical trials, it was compared against M-M-R II, which is a licensed MMR vaccine, to assess its immunogenicity.