Tags

Type your tag names separated by a space and hit enter

A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process.
Hum Vaccin Immunother. 2016 08 02; 12(8):2188-2196.HV

Abstract

Vaccination against measles, mumps, rubella, and varicella is recommended for all children in the US. Limitations manufacturing Oka/Merck strain varicella-zoster virus have hampered the availability of the combination vaccine (MMRV) against these 4 viruses, which drove the need to investigate an alternative manufacturing process. Healthy children 12-to-23 months of age at 71 US sites were randomized (1:1) to receive MMRV manufactured using an alternative process (MMRVAMP) or the currently licensed MMRV. Subjects received 2 0.5 mL doses 3 months apart. Sera were collected before and 6 weeks after Dose-1. Adverse experiences (AEs) were collected for 42 d after each dose and serious AEs and events of special interest for 180 d after Dose-2. Overall, 706 subjects were randomized to MMRVAMP and 706 to MMRV and 698 and 702 received at least 1 dose of study vaccine, respectively. The risk difference in response rates and geometric mean concentrations of antibody to measles, mumps, rubella, and varicella viruses 6 weeks after Dose-1 met non-inferiority criteria for MMRVAMP versus, MMRV. Response rates met acceptability criteria for each virus, and the seroconversion rate to varicella-zoster virus was 99.5% in both groups. Vaccine-related AEs were mostly mild-to-moderate in intensity and somewhat more common after MMRVAMP. Febrile seizures occurred at similar rates in both groups during the first 42 d after each vaccine dose. MMRVAMP is non-inferior to MMRV and represents an important advancement in maintaining an adequate supply of vaccines against these diseases.

Authors+Show Affiliations

a University of Louisville School of Medicine , Louisville , KY , USA.b Senders Pediatrics , Cleveland , OH , USA.c Ohio Pediatric Research , Dayton , OH , USA.d Dixie Pediatrics , St. George , UT , USA.e Merck & Co., Inc. , Kenilworth , NJ , USA.e Merck & Co., Inc. , Kenilworth , NJ , USA.e Merck & Co., Inc. , Kenilworth , NJ , USA.f Covance Inc. , Princeton , NJ , USA.e Merck & Co., Inc. , Kenilworth , NJ , USA.e Merck & Co., Inc. , Kenilworth , NJ , USA.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27149048

Citation

Marshall, Gary S., et al. "A Double Blind, Randomized, Active Controlled Study to Assess the Safety, Tolerability and Immunogenicity of Measles, Mumps Rubella, and Varicella Vaccine (MMRV) Manufactured Using an Alternative Process." Human Vaccines & Immunotherapeutics, vol. 12, no. 8, 2016, pp. 2188-2196.
Marshall GS, Senders SD, Shepard J, et al. A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process. Hum Vaccin Immunother. 2016;12(8):2188-2196.
Marshall, G. S., Senders, S. D., Shepard, J., Twiggs, J. D., Gardner, J., Hille, D., Hartzel, J., Valenzuela, R., Stek, J. E., & Helmond, F. A. (2016). A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process. Human Vaccines & Immunotherapeutics, 12(8), 2188-2196.
Marshall GS, et al. A Double Blind, Randomized, Active Controlled Study to Assess the Safety, Tolerability and Immunogenicity of Measles, Mumps Rubella, and Varicella Vaccine (MMRV) Manufactured Using an Alternative Process. Hum Vaccin Immunother. 2016 08 2;12(8):2188-2196. PubMed PMID: 27149048.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process. AU - Marshall,Gary S, AU - Senders,Shelly D, AU - Shepard,Julie, AU - Twiggs,Jerry D, AU - Gardner,Julie, AU - Hille,Darcy, AU - Hartzel,Jonathan, AU - Valenzuela,Rowan, AU - Stek,Jon E, AU - Helmond,Frans A, Y1 - 2016/05/05/ PY - 2016/5/6/pubmed PY - 2017/10/20/medline PY - 2016/5/6/entrez KW - MMRV KW - immunogenicity KW - measles KW - mumps KW - rubella KW - safety KW - varicella SP - 2188 EP - 2196 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 12 IS - 8 N2 - Vaccination against measles, mumps, rubella, and varicella is recommended for all children in the US. Limitations manufacturing Oka/Merck strain varicella-zoster virus have hampered the availability of the combination vaccine (MMRV) against these 4 viruses, which drove the need to investigate an alternative manufacturing process. Healthy children 12-to-23 months of age at 71 US sites were randomized (1:1) to receive MMRV manufactured using an alternative process (MMRVAMP) or the currently licensed MMRV. Subjects received 2 0.5 mL doses 3 months apart. Sera were collected before and 6 weeks after Dose-1. Adverse experiences (AEs) were collected for 42 d after each dose and serious AEs and events of special interest for 180 d after Dose-2. Overall, 706 subjects were randomized to MMRVAMP and 706 to MMRV and 698 and 702 received at least 1 dose of study vaccine, respectively. The risk difference in response rates and geometric mean concentrations of antibody to measles, mumps, rubella, and varicella viruses 6 weeks after Dose-1 met non-inferiority criteria for MMRVAMP versus, MMRV. Response rates met acceptability criteria for each virus, and the seroconversion rate to varicella-zoster virus was 99.5% in both groups. Vaccine-related AEs were mostly mild-to-moderate in intensity and somewhat more common after MMRVAMP. Febrile seizures occurred at similar rates in both groups during the first 42 d after each vaccine dose. MMRVAMP is non-inferior to MMRV and represents an important advancement in maintaining an adequate supply of vaccines against these diseases. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/27149048/A_double_blind_randomized_active_controlled_study_to_assess_the_safety_tolerability_and_immunogenicity_of_measles_mumps_rubella_and_varicella_vaccine__MMRV__manufactured_using_an_alternative_process_ L2 - https://www.tandfonline.com/doi/full/10.1080/21645515.2016.1165374 DB - PRIME DP - Unbound Medicine ER -