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Mmr vaccine contains hydrolyzed gelatin12/19/2023 ![]() ![]() ![]() A second dose is administered at 4 to 6 years of age. The first dose is administered at 12 to 15 months of age. Toxicology: Nonclinical Toxicology: Carcinogenesis, Mutagenesis, Impairment of Fertility: M-M-R II vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.ĭose and Schedule: Each 0.5 mL dose is administered subcutaneously. When the 6-month-old infants of immunized mothers were revaccinated at 15 months with M-M-R II vaccine, they developed antibody titers similar to those of toddlers who were vaccinated previously at 15-months of age. In these studies, a single injection of the vaccine induced measles HI antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of susceptible individuals.Ī study of 6-month-old and 15-month-old infants born to mothers vaccinated with a measles vaccine in childhood, demonstrated that, following infant and toddler vaccination with Measles Virus Vaccine, Live (previously US-licensed, manufactured by Merck), 74% of the 6-month-old infants developed detectable neutralizing antibody titers while 100% of the 15-month-old infants vaccinated with Measles Virus Vaccine, Live or M-M-R II vaccine developed neutralizing antibodies. Immunogenicity: Clinical studies enrolling 284 triple seronegative children, 11 months to 7 years of age, demonstrated that M-M-R II vaccine is immunogenic. These studies also established that seroconversion in response to vaccination against measles, mumps and rubella paralleled protection. Persistence of Antibody Responses After Vaccination: Neutralizing and ELISA antibodies to measles, mumps, and rubella viruses are still detectable in 95-100%, 74-91%, and 90-100% of individuals respectively, 11 to 13 years after primary vaccination.Ĭlinical Studies: Clinical Efficacy: Efficacy of measles, mumps, and rubella vaccines was established in a series of double-blind controlled trials. Results from efficacy studies or effectiveness studies that were previously conducted for the component vaccines of M-M-R II were used to define levels of serum antibodies that correlated with protection against measles, mumps, and rubella. Pharmacology: Mechanism of Action: M-M-R II vaccination induces antibodies to measles, mumps, and rubella associated with protection which can be measured by neutralization assays, hemagglutination-inhibition (HI) assays, or enzyme linked immunosorbent assay (ELISA) tests. The cells, virus pools, recombinant human serum albumin and fetal bovine serum used in manufacturing are tested and determined to be free of adventitious agents.Īfter reconstitution, each 0.5 mL dose contains not less than 3.0 log 10 TCID 50 (tissue culture infectious doses) of measles virus 4.1 log 10 TCID 50 of mumps virus and 3.0 log 10 TCID 50 of rubella virus.Įxcipients/Inactive Ingredients: Each dose is calculated to contain sorbitol (14.5 mg), sucrose (1.9 mg), porcine hydrolyzed gelatin (14.5 mg), recombinant human albumin (≤0.3 mg), approximately 25 mcg of neomycin and other buffer and media ingredients. M-M-R II vaccine is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live, an attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture (2) Mumps Virus Vaccine Live, the Jeryl Lynn (B level) strain of mumps virus propagated in chick embryo cell culture and (3) Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts. ![]()
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