Rubella virus vaccine

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants	2018/08/08	NCT03621670	Phase 3	Completed	GlaxoSmithKline

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Vax Sode	Nutritional Specialties, Inc.	83027-0071	ORAL	30 [hp_X] in 1 mL	5/15/2025
Viri Sode	Nutritional Specialties, Inc.	83027-0070	ORAL	16 [hp_X] in 1 mL	5/15/2025
BIOTOX V MMR	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
M-M-RVaxPro	Merck Sharp & Dohme B.V.,Waarderweg 39,2031 BN Haarlem,The Netherlands	Authorised	5/5/2006

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
M-M-R II VACCINE	Merck Sharp & Dohme LLC, Jubilant HollisterStier LLC (Sterile diluent), Merck Sharp & Dohme LLC (Sterile Diluent)	SIN02056P	INJECTION, POWDER, FOR SOLUTION	min 1000 CCID50/0.5 ml	6/24/1988
PRIORIX VACCINE	Fidia Farmaceutici S.P.A, GlaxoSmithKline Biologicals - Diluent in ampoules, Delpharm Tours - Diluent in ampoules, Corixa Corporation d/b/a GlaxoSmithKline Vaccines, Aspen Notre Dame De Bondeville - Diluent in syringes, Catalent Belgium SA - Diluent in syringes, Fidia Farmaceutici S.P.A (Diluent in ampoules)	SIN10822P	INJECTION, POWDER, FOR SOLUTION	min 1000 TCID50	3/22/1999
ProQuad Refrigerator Stable Formulation	Merck Sharp & Dohme LLC, Vetter Pharma-Fertigung GmbH &Co., KG (Diluent sterile WFI Syringe), Merck Sharp & Dohme LLC (Diluent sterile WFI Vial), Jubilant HollisterStier LLC (Diluent Sterile WFI vial)	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	MERCK SHARP & DOHME (ASIA) LIMITED	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	GlaxoSmithKline Australia Pty Ltd	Medicine	A	11/3/2003
PRIORIX-TETRA Vaccine 0.5mL powder for injection vial with diluent syringe	107286	GlaxoSmithKline Australia Pty Ltd	Medicine	A	11/16/2005
M-M-R II powder for injection vial with diluent pre-filled syringe, single dose	201877	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	12/12/2012
M-M-R II Powder for Injection Vial with Diluent Vial, single dose	118449	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	2/14/2006
PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial with sterile diluent vial composite pack	337388	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	8/12/2020
M-M-R II Powder for Injection Vial, single dose	118451	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	2/14/2006
PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial	126153	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	2/8/2007
PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial with prefilled diluent syringe	126157	Merck Sharp & Dohme (Australia) Pty Ltd	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	GlaxoSmithKline Inc	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	GlaxoSmithKline Inc	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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