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Vaccine Detail

Meruvax II
Vaccine Information
  • Vaccine Name: Meruvax II
  • Target Pathogen: Rubella virus
  • Target Disease: Rubella
  • Product Name: Rubella Virus Vaccine Live
  • Tradename: Meruvax II
  • Manufacturer: Merck & Co., Inc.
  • Vaccine Ontology ID: VO_0000073
  • CDC CVX code: 06
  • Type: Live, attenuated vaccine
  • Status: Licensed
  • Location Licensed: USA (License #0002)
  • Host Species for Licensed Use: Human
  • Antigen: Wistar Institute RA 27/3 strain of live attenuated rubella virus
  • Preparation: MERUVAX II is a sterile lyophilized preparation of the Wistar Institute RA 27/3 strain of live attenuated rubella virus. The virus was adapted to and propagated in WI-38 human diploid lung fibroblasts. The growth medium is Minimum Essential Medium (MEM) containing human serum albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests. The cells, virus pools, fetal bovine serum, and human albumin are all screened for the absence of adventitious agents. Human albumin is processed using the Cohn cold ethanol fractionation procedure. The product contains no preservative (FDA: Meruvax II).
  • Immunization Route: Intradermal injection (i.d.)
  • Storage: The vaccine must be maintained at a temperature of 10°C (50°F) or colder.
  • Approved Age for Licensed Use: 6-15 months is the recommended age
  • Contraindication: Hypersensitivity to any component of the vaccine, including gelatin, and anaphylactic or anaphylactoid reactions to neomycin (FDA: Meruvax II).
  • Description: MERUVAX* II (Rubella Virus Vaccine Live) is a live virus vaccine for vaccination against rubella (German measles) (FDA: Meruvax II) .
Host Response

Human Response

  • Vaccination Protocol: Clinical studies have been carried out in more than 28,000 human subjects (approximately 11,000 with MERUVAX II) in the United States and more than 20 additional countries (FDA: Meruvax II).
  • Immune Response: A single injection of the vaccine has been shown to induce rubella hemagglutination-inhibition (HI) antibodies in 97% or more of susceptible persons.
  • Side Effects: Side effects of vaccination include: fever, headache, dizziness, and itching, redness or swelling of the injection site.
  • Efficacy: Clinical studies helped to establish that seroconversion in response to rubella vaccination paralleled protection from this disease.
References
FDA: Meruvax II: FDA: Meruvax II vaccine information [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094064.htm]