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 Phase 2 measles, mumps, and rubella (MMR) vaccine candidate developed by GSK plc. It was studied as an alternative to the licensed M-M-R II vaccine when given alongside routine childhood vaccines to healthy children 12 to 15 months of age.
GSK Biological's investigational vaccine 209762 is being studied for protection against rubella, along with measles and mumps, as part of a combined MMR vaccine. The Phase 2 trial enrolled healthy children 12 to 15 months old to assess immune response when the vaccine was given with routine childhood immunizations.
GSK Biological's investigational vaccine 209762 is made by GSK plc, which trades under the ticker GSK. GSK Biologicals is the company's vaccine division, and it sponsored the Phase 2 study of the candidate.
GSK Biological's investigational vaccine 209762 is in Phase 2 development. It is an investigational product and is not an approved vaccine. The single registered trial, NCT00861744, has been completed, and no trials for this candidate are currently listed as active.
GSK Biological's investigational vaccine 209762 has been studied in one completed Phase 2 trial, NCT00861744, titled Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R II, When Given With Routine Vaccines at 12-15 Months of Age. It was a randomized, double-blind, active-controlled study that enrolled 1,259 healthy children in the United States and Puerto Rico.
NCT00861744 compared GSK Biological's investigational vaccine 209762 with the licensed M-M-R II vaccine in 1,259 healthy children aged 12 to 15 months. The trial was randomized, double-blind, and active-controlled, and it evaluated immunogenicity when the vaccine was given together with routine childhood vaccines. The study has been completed.