Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Priorix · 7 trials · 9 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.
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.
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
| 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). |
| 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. |
| Meningitec + Hiberix Group | ACTIVE_COMPARATOR | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Menitorix Group | EXPERIMENTAL | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| 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. |
| GSK Biological's investigational MMRV vaccine 208136 | BIOLOGICAL | Subcutaneous injection |
| Priorix™ | BIOLOGICAL | Subcutaneous injection |
| Varilrix™ | BIOLOGICAL | Subcutaneous injection |
| Haemophilus influenzae type b and meningococcal serogroup C (vaccine) | BIOLOGICAL | One intramuscular dose at 12-18 months of age |
| Hiberix™ | BIOLOGICAL | One intramuscular dose at 12-18 months of age. |
| Meningitec™ | BIOLOGICAL | One intramuscular dose at 12-18 months of age |
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 immunization against measles, mumps, rubella, and varicella. It is being studied in children as young as 9 months and in adults 7 years and older. The vaccine is developed by GSK plc.
Priorix is developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is currently in Phase 3 clinical development for infectious disease indications.
Priorix is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. All completed trials are Phase 3 studies evaluating safety and immunogenicity.
Priorix has completed four Phase 3 trials, including NCT00969436, NCT01702428, NCT02058563, and NCT02184572. These trials enrolled a total of 6,012 participants across countries such as the United States, India, Estonia, Finland, Mexico, and Taiwan.
Priorix is not the same as M-M-R II, but it has been directly compared to Merck's M-M-R II vaccine in clinical trials. Studies like NCT01702428 and NCT02184572 evaluated Priorix against M-M-R II in children 12 to 15 months of age.
Priorix targets measles, mumps, rubella, and varicella viruses. It is designed to generate an immune response against these infectious agents, providing protection against the respective diseases. The vaccine is being studied for use in healthy children and adults.