Overview
Rubella virus vaccine is a live attenuated virus vaccine for active immunization against rubella (German measles) that is subcutaneously administered. It is prepared from RA 27/3 strain of live attenuated rubella virus. Rubella is a common childhood disease, caused by rubella virus (togavirus).
Indication
Rubella virus vaccine is used to prevent rubella in combination with other virus vaccines, such as the mumps and measles virus vaccine.
Associated Conditions
- Measles
- Mumps
- Rubella
Research Report
Rubella Virus Vaccine (DB10317): A Comprehensive Monograph on its Virology, Clinical Application, and Public Health Legacy
1.0 Executive Summary
The Rubella virus vaccine (DrugBank ID: DB10317) is a cornerstone of modern preventive medicine, classified as a live attenuated biotech product designed for active immunization against rubella, also known as German measles.[1] The vaccine is prepared from the Wistar RA 27/3 strain of the rubella virus, a component selected for its superior immunogenicity, which has proven critical to the vaccine's global success.[1] Its mechanism of action relies on inducing a controlled, limited replication of the attenuated virus within the host, thereby mimicking natural infection to stimulate a robust and durable immune response without causing significant disease.[4] This process elicits both a strong humoral response, characterized by high-titer neutralizing antibodies, and a cell-mediated response involving rubella-specific T-lymphocytes.[5]
Clinically, the vaccine demonstrates exceptionally high efficacy, with a single dose conferring approximately 97% protection against rubella, and a second dose increasing this to nearly 99%.[6] The immunity conferred is considered lifelong.[6] The paramount public health objective of the rubella vaccination program is the prevention of Congenital Rubella Syndrome (CRS), a devastating condition that can cause severe birth defects, fetal death, or neonatal death when a pregnant woman is infected with the wild-type virus.[5] In many countries, including the United States, the rubella vaccine is exclusively available in combination formulations, primarily the measles-mumps-rubella (MMR) vaccine and the measles-mumps-rubella-varicella (MMRV) vaccine, a strategic approach that maximizes protection against multiple diseases at each clinical encounter.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2018/08/08 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Nutritional Specialties, Inc. | 83027-0153 | ORAL | 30 [hp_X] in 1 mL | 9/22/2025 | |
Nutritional Specialties, Inc. | 83027-0071 | ORAL | 30 [hp_X] in 1 mL | 5/15/2025 | |
Nutritional Specialties, Inc. | 83027-0070 | ORAL | 16 [hp_X] in 1 mL | 5/15/2025 | |
The Wellness Center for Research and Education, Inc. | 50181-0042 | ORAL | 30 [hp_X] in 1 mL | 5/28/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 5/5/2006 | ||
Authorised | 5/5/2006 | ||
Authorised | 5/5/2006 | ||
Authorised | 5/5/2006 | ||
Authorised | 5/5/2006 | ||
Authorised | 5/5/2006 | ||
Authorised | 5/5/2006 | ||
Authorised | 5/5/2006 | ||
Authorised | 5/5/2006 | ||
Authorised | 5/5/2006 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
M-M-R II VACCINE | SIN02056P | INJECTION, POWDER, FOR SOLUTION | min 1000 CCID50/0.5 ml | 6/24/1988 | |
PRIORIX VACCINE | SIN10822P | INJECTION, POWDER, FOR SOLUTION | min 1000 TCID50 | 3/22/1999 | |
ProQuad Refrigerator Stable Formulation | SIN13563P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 3.00 log TCID 50/ dose | 10/23/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
PROQUAD VACCINE | N/A | N/A | N/A | 10/5/2006 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
PRIORIX ALBUMIN FREE VACCINE 0.5mL powder for injection vial and diluent syringe | 97842 | Medicine | A | 11/3/2003 | |
PRIORIX-TETRA Vaccine 0.5mL powder for injection vial with diluent syringe | 107286 | Medicine | A | 11/16/2005 | |
M-M-R II powder for injection vial with diluent pre-filled syringe, single dose | 201877 | Medicine | A | 12/12/2012 | |
M-M-R II Powder for Injection Vial with Diluent Vial, single dose | 118449 | Medicine | A | 2/14/2006 | |
PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial with sterile diluent vial composite pack | 337388 | Medicine | A | 8/12/2020 | |
M-M-R II Powder for Injection Vial, single dose | 118451 | Medicine | A | 2/14/2006 | |
PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial | 126153 | Medicine | A | 2/8/2007 | |
PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial with prefilled diluent syringe | 126157 | Medicine | A | 2/8/2007 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
MORU-VIRATEN BERNA VACCINE | swiss serum and vaccine institute berne | 02211017 | Powder For Solution
,
Liquid - Subcutaneous | 1 DOSE / KIT | 3/7/1996 |
PRIORIX-TETRA | 02297884 | Powder For Solution - Intramuscular
,
Subcutaneous | 1000 CCID50 / 0.5 ML | 6/4/2008 | |
RUBELLA VIRUS VACC LIVE ATT FREEZ DRIED INJ | iaf biovac inc. | 01915290 | Powder For Solution - Subcutaneous | 1000 UNIT / VIAL | 12/31/1991 |
PRIORIX | 02239208 | Kit
,
Powder For Solution - Intramuscular
,
Subcutaneous | 1000 CCID50 / 0.5 ML | 12/4/1998 | |
RUBELLA VIRUS VACCINE LIVE DRIED ATTENUATED | aventis pasteur limited | 00596396 | Powder For Solution - Subcutaneous | 1000 UNIT / 0.5 ML | 12/31/1983 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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