Data updated: May 26, 2026
PRIORIX (measles, mumps and rubella vaccine live)
Approved 2022-06-02
1
Indication
--
Phase 3 Trials
3
Years on Market
Details
- Status
- Prescription
- First Approved
- 2022-06-02
- Routes
- Subcutaneous
- Dosage Forms
- For Injection
PRIORIX Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2022 to 2022
Jun 2022 ORIGINAL
Update · CBER biologic (Purple Book)
What PRIORIX Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2022)
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Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06824194 | PSK05 U1111-1295-5983 | Ph 3 | active not recruiting | Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age |
| NCT06824181 | PSK00031 U1111-1294-7911 | Ph 3 | active not recruiting | Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age |
| NCT01681992 results posted | 115649 2011-004905-26 | Ph 3 | completed | Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life |
| NCT02184572 results posted | 115650 2011-006161-18 | Ph 3 | completed | Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age |
| NCT01627561 results posted | 115887 2011-005604-15 | Ph 3 | completed | Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old |
| NCT01702428 results posted | 115648 2011-004891-12 | Ph 3 | completed | Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age |
| NCT01621802 results posted | 115158 2011-004638-32 | Ph 3 | completed | Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PRIORIX FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.