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GSK Biological's investigational MMRV vaccine 208136 · 1 trial · 4 indications
Seroconversion was defined as the appearance of antibodies \[i.e. concentration/titre greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.
| Arm | Type | Description |
|---|---|---|
| Priorix-Tetra Group | EXPERIMENTAL | Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh. |
| Priorix/ Priorix-Tetra Group | EXPERIMENTAL | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh. |
| Control Group | ACTIVE_COMPARATOR | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh. |
| Name | Type | Description |
|---|---|---|
| GSK Biological's investigational MMRV vaccine 208136 | BIOLOGICAL | Subcutaneous injection |
| Priorix™ | BIOLOGICAL | Subcutaneous injection |
| Varilrix™ | BIOLOGICAL | Subcutaneous injection |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * Male or female subjects between and including 9 and 10 months of age at the time of the first vaccination. * Written...
It is an investigational combination vaccine developed by GSK plc that targets measles, mumps, rubella, and varicella in a single product. The candidate is in Phase 3 clinical development, with varicella listed as its lead indication. It is designed to protect against all four of these infectious diseases.
It is being developed for the prevention of measles, mumps, rubella, and varicella. The Phase 3 trial enrolled healthy children from 9 months of age in India. The varicella indication is the primary focus of the program, and the vaccine remains investigational rather than approved.
GSK plc, which trades under the ticker GSK, is the developer of this investigational MMRV vaccine candidate. The program is part of GSK's infectious disease vaccine portfolio and has completed one Phase 3 clinical trial to date.
It is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The candidate is investigational and has not been approved for use.
The program includes the completed Phase 3 trial NCT00969436, titled Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM. It enrolled 450 healthy participants aged 9 months and older in India, used an active control, and was randomized but not double-blind.