Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK Biologicals' live attenuated measles, mumps, rubella vaccine
Priorix · 5 trials · 6 indications
Fever was assessed for temperature equal to/above (≥) 38.0°C and above (\>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV\_MMR minus COM\_MMR) in incidence of fever equal to or below the cut-off value.
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL). Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in EU/mL. Seropositivity was defined as subjects with anti-mumps virus antibody concentration equal or greater than 5 EU/mL
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. Seropositivity was defined as subjects with anti-rubella virus antibody concentration equal or greater than 4 IU/mL
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration \<150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations \<5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations \<4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV\_MMR\_L1, INV\_MMR\_L2 and INV\_MMR\_L3 as analysis was performed on subjects who received one of the lots of INV\_MMR vaccine.
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration \<150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV\_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV\_MMR lots is ≥90% for antibodies to measles virus.
Antibody concentrations were expressed as GMCs in mIU/mL.
Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations \<5 EU/mL) before vaccination.
Antibody concentrations were expressed as GMCs in EU/mL.
Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations \<4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV\_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV\_MMR lots is ≥90% for antibodies to rubella virus.
Antibody concentrations were expressed as GMCs in IU/mL.
For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above \[≥\] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than \[\<\] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv\_MMR\_Min/Inv\_MMR\_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\_MMR\_Min/Inv\_MMR\_Med was to be ≥ 90% for antibodies to measles virus.
For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration \< 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv\_MMR\_Min/Inv\_MMR\_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\_MMR\_Min/Inv\_MMR\_Med was to be ≥ 90% for antibodies to mumps virus.
For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration \< 2.5 ED50) before dose 1.
For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration \< 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv\_MMR\_Min/Inv\_MMR\_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\_MMR\_Min/Inv\_MMR\_Med was to be ≥ 90% for antibodies to mumps virus.
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
Antibody concentrations were expressed as GMCs in EU/mL.
Antibody concentrations were expressed as Geometric Mean Titers (GMTs).
Antibody concentrations were expressed as GMCs in IU/mL.
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.
| Arm | Type | Description |
|---|---|---|
| INV_MMR | EXPERIMENTAL | Subjects receive 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0. |
| COM_MMR | ACTIVE_COMPARATOR | Subjects receive 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0. |
| INV_MMR Group | EXPERIMENTAL | Subjects will receive 1 dose of GSK Biologicals' trivalent Measles, Mumps, and Rubella Virus Vaccine (Priorix®). |
| COM_MMR Group | ACTIVE_COMPARATOR | Subjects will receive 1 dose of Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine. |
| INV_MMR_L1 Group | EXPERIMENTAL | Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV\_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. |
| INV_MMR_L2 Group | EXPERIMENTAL | Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV\_MMR) Lot 2 (L2) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. |
| INV_MMR_L3 Group | EXPERIMENTAL | Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV\_MMR) Lot 3 (L3) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. |
| Inv_MMR_Min Group | EXPERIMENTAL | Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\_MMR), from a minimum potency lot (Inv\_MMR\_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. |
| Inv_MMR_Med Group | EXPERIMENTAL | Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\_MMR), from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. |
| Inv _MMR_CO Group | EXPERIMENTAL | Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). |
| Com_MMR_CO Group | ACTIVE_COMPARATOR | Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). |
| Inv_MMR_I Group | EXPERIMENTAL | Subjects received one dose of Priorix at Visit 1 (Day 0). |
| Com_MMR_I Group | ACTIVE_COMPARATOR | Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). |
| Inv _MMR_S Group | EXPERIMENTAL | Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0). |
| Com_MMR_S Group | ACTIVE_COMPARATOR | Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). |
| Name | Type | Description |
|---|---|---|
| Priorix | BIOLOGICAL | 1 dose administered subcutaneously in the triceps region of left arm at Day 0 |
| M-M-R II | BIOLOGICAL | 1 dose administered subcutaneously in the triceps region of left arm at Day 0 |
| Varivax | BIOLOGICAL | 1 dose administered subcutaneously in the triceps region of right arm at Day 0 |
| Havrix | BIOLOGICAL | 1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0 |
| Prevnar 13 | BIOLOGICAL | 1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US |
| Priorix® | BIOLOGICAL | 1 dose administered as a subcutaneous (SC) injection. |
| Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine | BIOLOGICAL | 1 dose administered subcutaneously. |
| Kinrix | BIOLOGICAL | One dose administered by deep intramuscular injection in the upper left deltoid. |
| ProQuad | BIOLOGICAL | One dose administered subcutaneously in the triceps region of the left arm. |
Inclusion Criteria: * Male or female child between 12 and 15 months of age (e.g., from the 1 year birthday until the day before age 16 months) at the time of vaccination. * Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comp...
Priorix is a vaccine used for protection against measles, mumps, and rubella. It is indicated for active immunization against these three viral infections, which is why it is commonly referred to as an MMR vaccine. It is given to children and older individuals to prevent measles, mumps, and rubella disease.
Priorix is developed and manufactured by GSK plc, which trades under the ticker GSK. GSK Biologicals conducted the clinical development program for the vaccine, including the Phase 3 studies that evaluated its immunogenicity and safety against a comparator MMR vaccine.
Priorix has been evaluated in Phase 3 clinical development. Its trials are listed as completed, including studies in children 12 to 15 months of age and in volunteers seven years of age and older. The Phase 3 program enrolled several thousand healthy participants across multiple countries.
Priorix has been studied in completed Phase 3 trials including NCT01702428, NCT01681992, NCT02184572, and NCT02058563. These trials assessed immunogenicity and safety in healthy children and older volunteers, with enrollment ranging from 996 to 5,016 participants, and were conducted across the United States, Europe, Asia, and Puerto Rico.
Yes, Priorix, Priorix™, and Priorix® all refer to the same GSK measles, mumps, and rubella vaccine. The trademark symbols are simply stylized forms of the same product name, so searches for any of these variations refer to the identical MMR vaccine developed by GSK.
Priorix was evaluated in randomized, double-blind, active-controlled Phase 3 trials. The studies compared its immunogenicity and safety against Merck's MMR vaccine in healthy children 12 to 15 months of age and in volunteers seven years of age and older, with total enrollment across the program exceeding 6,000 participants.