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

References

• Centers for Disease Control and Prevention. Recommended immunization schedules for persons aged 0 through 18 years—United States, 2015. http://www.cdc.gov/vaccines/schedules/downloads/child/0–18yrs-schedule.pdf (accessed January 25, 2016).
   Google Scholar
• Centers for Disease Control and Prevention (CDC). Use of combination measles, mumps, rubella, and varicella, vaccine: recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2010; 59:1-15; PMID:20075837
   PubMedGoogle Scholar
• Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2011; 60(RR-2):1-61.
   Google Scholar
• U.S. Food an Drug Administration. M-M-R ®II (Measles, Mumps, and Rubella Virus Vaccine Live) [package insert]. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM123789.pdf
   Google Scholar
• U.S. Food an Drug Administration. Varivax (Varicella Virus Vaccine Live) [package insert]. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142812.pdf
   Google Scholar
• Bottiger M, Christenson B, Romanus V, Taranger J, Strandell A. Swedish experience of two dose vaccination programme aiming at eliminating measles, mumps, and rubella. BMJ 1987; 295:1264-7; PMID:3120971; http://dx.doi.org/10.1136/bmj.295.6608.1264
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Summary of notifiable diseases, United States, 1998. MMWR Morb and Mortal Wkly Rep 1999; 47:1-93.
   Google Scholar
• Centers for Disease Control and Prevention. Measles. In: W Atkinson, C Wolfe, S Humiston, R Nelson, eds. Epidemiology and prevention of vaccine-preventable diseases. 6 ed. Atlanta (GA): Centers for Disease Control and Prevention, 2000:115-33.
   Google Scholar
• Nguyen HQ, Jumaan AO, Seward JF. Decline in mortality due to varicella after implementation of varicella vaccination in the United States. N Engl J Med 2005; 352:450-8; PMID:15689583; http://dx.doi.org/10.1056/NEJMoa042271
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Varicella-related deaths, United States, January 2003 – June 2004. MMWR Morb and Mortal Wkly Rep 2005; 54:272-4.
   PubMedGoogle Scholar
• Seward JF, Watson BM, Peterson CL, Mascola L, Pelosi JW, Zhang JX, Maupin TJ, Goldman GS, Tabony LJ, Brodovicz KG, et al. Varicella disease after introduction of varicella vaccine in the United States, 1995–2000. JAMA 2002; 287:606-11; PMID:11829699; http://dx.doi.org/10.1001/jama.287.5.606
   PubMed Web of Science ®Google Scholar
• Maupin T, Civen R, Jumaan A, Xiao H, Seward J, Mascola L. Varicella outbreaks in an active surveillance site; Antelope Valley, CA, 1995–2003. Abstract presented at the 38th Annual National Immunization Conference, Nashville, TN. May 11–14, 2004.
   Google Scholar
• Clements DA, Zaref JI, Bland CL, Walter EB, Coplan PM. Partial uptake of varicella vaccine and the epidemiological effect on varicella disease in 11 day-care centers in North Carolina. Arch Pediatr Adolesc Med 2001; 155:455-61; PMID:11296072; http://dx.doi.org/10.1001/archpedi.155.4.455
   PubMed Web of Science ®Google Scholar
• Vázquez M, LaRussa P, Gershon A, Steinberg SP, Freudigman K, Shaprio ED. The effectiveness of the varicella vaccine in clinical practice. N Engl J Med 2001; 344:955-60; http://dx.doi.org/10.1056/NEJM200103293441302
   PubMed Web of Science ®Google Scholar
• Vázquez M, LaRussa P, Gershon A, Niccolai LM, Muehlenbein CE, Steinberg SP, Shapiro ED. Effectiveness over time of varicella vaccine. JAMA 2004; 291:851-5; http://dx.doi.org/10.1001/jama.291.7.851
   PubMed Web of Science ®Google Scholar
• Clements D, Moreira S, Coplan P, Bland C, Walter E. Postlicensure study of varicella vaccine effectiveness in a day-care setting. Pediatr Infect Dis J 1999; 18:1047-50; PMID:10608622; http://dx.doi.org/10.1097/00006454-199912000-00004
   PubMed Web of Science ®Google Scholar
• Hill HH, Elam-Evans LD, Yankey D, Singleton JA, Kolasa M, Centers for Disease Control and Prevention (CDC). National, state, and selected local area vaccination coverage among children aged 19–35 months - United States, 2014. MMWR Morb Mortal Wkly Rep 2015; 64:889-96; PMID:26313470; http://dx.doi.org/10.15585/mmwr.mm6433a1
   PubMed Web of Science ®Google Scholar
• American Academy of Pediatrics Committee on Infectious Diseases. Policy statement—Prevention of varicella: update of recommendations for use of quadrivalent and monovalent varicella vaccines in children. Pediatrics 2011; 128:630-2; PMID:21873692; http://dx.doi.org/10.1542/peds.2011-1968
   PubMed Web of Science ®Google Scholar
• Kalies H, Grote V, Verstraeten T, Hessel L, Schmitt HJ, von Kries R. The use of combination vaccines has improved timeliness of vaccination in children. Pediatr Infect Dis J 2006; 25:507-12; PMID:16732148; http://dx.doi.org/10.1097/01.inf.0000222413.47344.23
   PubMed Web of Science ®Google Scholar
• Marshall GS, Happe LE, Lunacsek OE, Szymanski MD, Woods CR, Zahn M, Russell A. Use of combination vaccines is associated with improved coverage rates. Pediatr Infect Dis J 2007; 26:496-500; PMID:17529866; http://dx.doi.org/10.1097/INF.0b013e31805d7f17
   PubMed Web of Science ®Google Scholar
• Jacobsen SJ, Ackerson BK, Sy LS, Tran TN, Jones TL, Yao JF, Xie F, Cheetham TC, Saddier P. Observational safety study of febrile convulsion following first dose MMRV vaccination in a managed care setting. Vaccine 2009; 27:4656-61; PMID:19520201; http://dx.doi.org/10.1016/j.vaccine.2009.05.056
   PubMed Web of Science ®Google Scholar
• Klein NP, Fireman B, Yih WK, Lewis E, Kulldorff M, Ray P, Baxter R, Hambidge S, Nordin J, Naleway A, et al. Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures. Pediatrics 2010; 126:e1-8; PMID:20587679; http://dx.doi.org/10.1542/peds.2010-0665
   PubMed Web of Science ®Google Scholar
• Hauser WA. The prevalence and incidence of convulsive disorders in children. Epilepsia 1994; 35:S1-S6; PMID:8275976; http://dx.doi.org/10.1111/j.1528-1157.1994.tb05932.x
   PubMed Web of Science ®Google Scholar
• Pavlovic MV, Jarebinski MS, Pekmezovic TD, Marjanovic BD, Levic ZM. Febrile convulsions in a Serbian region: a 10-year epidemiological study. Eur J Neurol 1999; 6:39-42; PMID:10209348; http://dx.doi.org/10.1046/j.1468-1331.1999.610039.x
   PubMed Web of Science ®Google Scholar
• Forsgren L, Sidenvall R, Blomquist HKS, Heijbel J. A prospective incidence study of febrile convulsions. Acta Paediat Scand 1990; 79:550-7; PMID:2386045; http://dx.doi.org/10.1111/j.1651-2227.1990.tb11510.x
   PubMed Web of Science ®Google Scholar
• Hauser WA, Kurland LT. The epidemiology of epilepsy in Rochester, Minnesota, 1935 through 1967. Epilepsia 1975; 16:1-66; PMID:804401; http://dx.doi.org/10.1111/j.1528-1157.1975.tb04721.x
   PubMed Web of Science ®Google Scholar
• Verburgh ME, Bruijnzeels MA, van der Wouden JC, van Suijlekom-Smit LWA, van der Velden J, Hoes AW, Offringa M. Incidence of febrile seizures in The Netherlands. Neuroepidemiology 1992; 11:169-72; PMID:1291879; http://dx.doi.org/10.1159/000110928
   PubMed Web of Science ®Google Scholar
• Vestergaard M, Hviid A, Madsen K, Wohlfahrt J, Thorsen P, Schendel D, Melbye M, Olsen J. MMR vaccination and febrile seizures: evaluation of susceptible subgroups and long-term prognosis. JAMA 2004; 292(3):351-7; PMID:15265850; http://dx.doi.org/10.1001/jama.292.3.351
   PubMed Web of Science ®Google Scholar
• van den Berg BJ, Yerushalmy J. Studies on convulsive disorders in young children. I. Incidence of febrile and nonfebrile convulsions by age andother factors. Pediatr Res 1969; 3:298-304; PMID:5807059.
   PubMed Web of Science ®Google Scholar
• Reef SE, Cochi SL. The evidence for the elimination of rubella and congenital rubella syndrome in the United States: a public health achievement. Clin Infect Dis 2006; 43:S123-5; PMID:16998770; http://dx.doi.org/10.1086/505943
   PubMedGoogle Scholar
• Katz SL, Hinman AR. Summary and conclusions: measles elimination meeting, 16–17 March 2000. J Infect Dis 2004; 189:S43-7; PMID:15106088; http://dx.doi.org/10.1086/377696
   PubMed Web of Science ®Google Scholar
• Clemmons NS, Gastanaduy PA, Fiebelkorn AP, Redd SB, Wallace GS. Measles—United States, January 4-April 2, 2015. MMWR Morb Mortal Wkly Rep 2015; 64:373-6; PMID:25879894.
   PubMed Web of Science ®Google Scholar
• Adams DA, Jajosky RA, Ajani U, Kriseman J, Sharp P, Onwen DH, Schley AW, Anderson WJ, Grigoryan A, Aranas AE, et al. Summary of notifiable diseases—United States, 2012. MMWR Morb Mortal Wkly Rep 2014; 61:1-121; PMID:25233134.
   PubMedGoogle Scholar
• Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schödel F, et al. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J 2005; 24:665-9; PMID:16094217; http://dx.doi.org/10.1097/01.inf.0000172902.25009.a1
   PubMed Web of Science ®Google Scholar
• Shinefield H, Black S, Williams W, Marchant C, Reisinger K, Stewart T, Meissner HC, Guerrero J, Klopfer SO, Xu J, et al. Dose-response of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J 2005; 24:670-5; PMID:16094218; http://dx.doi.org/10.1097/01.inf.0000172901.29621.e9
   PubMed Web of Science ®Google Scholar
• Lieberman JM, Williams WR, Miller JM, Black S, Shinefield H, Henderson F, Marchant CD, Werzberger A, Halperin S, Hartzel J, et al. The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children: a study of manufacturing consistency and persistence of antibody. Pediatr Infect Dis J 2006; 25:615-22; PMID:16804432; http://dx.doi.org/10.1097/01.inf.0000220209.35074.0b
   PubMed Web of Science ®Google Scholar
• Shinefield H, Black S, Thear M, Coury D, Reisinger K, Rothstein E, Xu J, Hartzel J, Evans B, Digilio L, et al. Safety and immunogenicity of a measles, mumps, rubella and varicella vaccine given with combined Haemophilus influenzae type b conjugate/hepatitis B vaccines and combined diphtheria-tetanus-acellular pertussis vaccines. Pediatr Infect Dis J 2006; 25:287-92; PMID:16567978; http://dx.doi.org/10.1097/01.inf.0000207857.10947.1f
   PubMed Web of Science ®Google Scholar
• Bernstein HH, Eves K, Campbell K, Black SB, Twiggs JD, Reisinger KS, Conti RM, Flodmark CE, Rombo L, Klopfer S, et al. Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of ProQuad (measles, mumps, rubella, and varicella virus vaccine live). Pediatrics 2007; 119:e1299-305; PMID:17502347; http://dx.doi.org/10.1542/peds.2006-2283
   PubMedGoogle Scholar
• Keller PM, Lonengan K, Neff BJ, Morton DA, Ellis RW. Purification of individual varicella-zoster virus (VZV) glycoprotein gpI, gpII, and gpIII and their use in ELISA for detection of VZV glycoprotein-specific antibodies. J Virol Methods 1986; 14:177-88; PMID:3021804; http://dx.doi.org/10.1016/0166-0934(86)90048-0
   PubMed Web of Science ®Google Scholar
• Wasmuth EH, Miller WJ. Sensitive enzyme-linked immunosorbent assay for antibody to varicella-zoster virus using purified VZV glycoprotein antigen. J Med Virol 1990; 32:189-93; PMID:2177782; http://dx.doi.org/10.1002/jmv.1890320310
   PubMed Web of Science ®Google Scholar
• Provost PJ, Krah DL, Kuter BJ, Morton DH, Schofield TL, Wasmuth EH, White CJ, Miller WJ, Ellis RW. Antibody assays suitable for assessing immune responses to live varicella vaccine. Vaccine 1991; 9:111-6; PMID:1647574; http://dx.doi.org/10.1016/0264-410X(91)90266-9
   PubMed Web of Science ®Google Scholar