A combined measles, mumps, rubella and varicella vaccine (Priorix-Tetra™): Immunogenicity and safety profile

Vaccine

Volumn 27, Issue 47, 2009, Pages 6504-6511

  Czajka, Hanna ^a   Schuster, Volker ^b   Zepp, Fred ^c   Esposito, Susanna ^d   Douha, Martine ^d   Willems, Paul ^e  

^a Vaccination Outpatient Clinic   (Poland)

^b UNIVERSITY OF LEIPZIG   (Germany)

^c JOHANNES GUTENBERG UNIVERSITY   (Germany)

^d UNIVERSITY OF MILAN   (Italy)

^e GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

Author keywords

Combined MMRV vaccine; Immunogenicity; Reactogenicity

Indexed keywords

ANTIBIOTIC AGENT; ANTIPYRETIC AGENT; CHICKENPOX MEASLES MUMPS RUBELLA VACCINE; MEASLES MUMPS RUBELLA VACCINE; PRIORIX TETRA; UNCLASSIFIED DRUG; VARICELLA ZOSTER VACCINE;

CHICKENPOX; CLINICAL TRIAL; DRUG SAFETY; FEBRILE CONVULSION; FEVER; HUMAN; IMMUNITY; IMMUNOGENICITY; IMMUNOLOGY; INJECTION SITE PAIN; INJECTION SITE REACTION; PRIORITY JOURNAL; RASH; REVIEW; STATISTICAL ANALYSIS; SWELLING; TONSILLITIS; URTICARIA; VACCINATION;

ANTIBODIES, VIRAL; CHICKENPOX VACCINE; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; HUMANS; IMMUNIZATION, SECONDARY; INFANT; MEASLES-MUMPS-RUBELLA VACCINE;

EID: 70350786912     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2009.07.076     Document Type: Review

References (64)

1. Vesikari T., Sadzot-Delvaux C., Rentier B., and Gershon A. Increasing coverage and efficiency of measles, mumps, and rubella vaccine and introducing universal varicella vaccination in Europe: a role for the combined vaccine. Pediatr Infect Dis J 26 (2007) 632-638
2. Centers for Disease Control and Prevention. Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention. MMWR Recomm Rep 1996;45:1-36.
3. Centers for Disease Control and Prevention. Varicella-related deaths-United States, January 2003-June 2004. MMWR Morb Mortal Wkly Rep 54 (2005) 272-274
4. Centers for Disease Control and Prevention. Varicella. In: Atkinson W., Hamborsky J., McIntyre L., et al. (Eds). Epidemiology and prevention of vaccine-preventable diseases. 10th ed. (2007), Public Health Foundation, Washington, DC 175-196
5. Davis M.M., Patel M.S., and Gebremariam A. Decline in varicella-related hospitalizations and expenditures for children and adults after introduction of varicella vaccine in the United States. Pediatrics 114 (2004) 786-792
6. Nguyen H.Q., Jumaan A.O., and Seward J.F. Decline in mortality due to varicella after implementation of varicella vaccination in the United States. N Engl J Med 352 (2005) 450-458
7. Seward J.F., Watson B.M., Peterson C.L., Mascola L., Pelosi J.W., Zhang J.X., et al. Varicella disease after introduction of varicella vaccine in the United States, 1995-2000. JAMA 287 (2002) 606-611
8. Heininger U., and Seward J.F. Varicella. Lancet 368 (2006) 1365-1376
9. Kuter B., Matthews H., Shinefield H., Black S., Dennehy P., Watson B., et al. Ten year follow-up of healthy children who received one or two injections of varicella vaccine. Pediatr Infect Dis J 23 (2004) 132-137
10. Marin M., Guris D., Chaves S.S., Schmid S., and Seward J.F. Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 56 (2007) 1-40
11. Sadzot-Delvaux C., Rentier B., Wutzler P., Asano Y., Suga S., Yoshikawa T., et al. Varicella vaccination in Japan, South Korea, and Europe. J Infect Dis 197 Suppl. 2 (2008) S185-S190
12. Sengupta N., Booy R., Schmitt H.J., Peltola H., Van-Damme P., Schumacher R.F., et al. Varicella vaccination in Europe: are we ready for a universal childhood programme?. Eur J Pediatr 167 (2008) 47-55
13. Goh P., Lim F.S., Han H.H., and Willems P. Safety and immunogenicity of early vaccination with two doses of tetravalent measles-mumps-rubella-varicella (MMRV) vaccine in healthy children from 9 months of age. Infection 35 (2007) 326-333
14. Nolan T., McIntyre P., Roberton D., and Descamps D. Reactogenicity and immunogenicity of a live attenuated tetravalent measles-mumps-rubella-varicella (MMRV) vaccine. Vaccine 21 (2002) 281-289
15. Vesikari T., Baer M., and Willems P. Immunogenicity and safety of a second dose of measles-mumps-rubella-varicella vaccine in healthy children aged 5 to 6 years. Pediatr Infect Dis J 26 (2007) 153-158
16. Zepp F., Otto W., Helm K., Meister N., Gildberg P.K., Kieninger D., et al. Antibody persistence and varicella breakthrough case assessment two years after administration of measles-mumps-rubella-varicella (MMRV) vaccine in children aged 11-23 months. 25th annual meeting of the European Society for Paediatric Infectious Diseases (ESPID). Porto, Portugal, May 2-4 (2007) [Abstract]
17. Arsene J.P., Gillet Y., Behre U., Desole M.G., Esposito S., Meister N., et al. Varicella vaccination in healthy children: assessment of one versus two doses in two age strata (15 mths-2 yrs and 2-6 yrs old). International congress of pediatrics. Athens, Greece (2007) [Abstract]
18. Arsene J.P., Gillet Y., Behre U., Desole M.G., Steri G.C., Helm K., et al. Immunogenicity and safety of measles-mumps-rubella-varicella vaccine in children from two age strata (15 mths-2 yrs and 2-6 yrs old) primed with measles-mumps-rubella vaccine. International congress of pediatrics. Athens, Greece (2007) [Abstract]
19. GlaxoSmithKline. GlaxoSmithKline clinical trial register: 104020 (MeMuRu-OKA-043). Available from: http://www.gsk-clinicalstudyregister.com/ [accessed 2 October, 2007].
20. Habermehl P., Zepp F., Sanger R., Otto W., Helm K., Meister N., et al. Assessment of varicella breakthrough cases one year after administration of two doses of a measles, mumps, rubella, varicella vaccine in the second year of life. 24th annual meeting of the European Society for Paediatric Infectious Diseases (ESPID). Basel, Switzerland, May 3-5 (2006) [Abstract]
21. Halperin S., Ferrera G., Scheifele D.W., Predy G., Stella G., Cuccia M., et al., MAdhu P. Safety and immunogenicity of a measles-mumps-rubella-varicella vaccine given as a second dose in children up to six years of age. Vaccine 27 (2009) 446-453
22. Knuf M., Habermehl P., Zepp F., Mannhardt W., Kuttnig M., Muttonen P., et al. Immunogenicity and safety of two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Pediatr Infect Dis J 25 (2006) 12-18
23. Zepp F., Sanger R., Otto W., Helm K., Meister N., Habermehl P., et al. Persistence of functional antibodies against mumps remains high one year after administration of two doses of a measles mumps, rubella, varicella (MMRV) vaccine in the second year of life. 24th annual meeting of the European Society for Paediatric Infectious Diseases (ESPID). Basel, Switzerland, May 2-4 (2006) [Abstract]
24. Schuster V., Otto W., Maurer L., Tcherepnine P., Pfletschinger U., Kindler K., et al. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J 27 (2008) 724-730
25. Mauldin J., Carbone K., Hsu H., Yolken R., and Rubin S. Mumps virus-specific antibody titers from pre-vaccine era sera: comparison of the plaque reduction neutralization assay and enzyme immunoassays. J Clin Microbiol 43 (2005) 4847-4851
26. Tischer A., Andrews N., Kafatos G., Nardone A., Berbers G., Davidkin I., et al. Standardization of measles, mumps and rubella assays to enable comparisons of seroprevalence data across 21 European countries and Australia. Epidemiol Infect 135 (2007) 787-797
27. Dodet M., Dessy F., Parent I., and Gerard P. Use of a neutralisation assay as an alternative for assessing mumps immunisation status. 24th annual meeting of the European Society for Paediatric Infectious Diseases (ESPID). Porto, Portugal, May 2-4 (2006) [Abstract]
28. Clopper C., and Pearson S. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26 (1934) 404-413
29. Zepp F., Manegold-Randel D., Helm K., Gildberg P.K., Knuf M., de La Bourdonnaye G., et al. Antibody persistence and varicella breakthrough case assessment three years after administration of measles-mumps-rubella-varicella (MMRV) vaccine in children aged 11-23 months. 26th annual meeting of the European Society for Pediatric Infectious Diseases (ESPID). Graz, Austria (2008) [Abstract]
30. Miller E. MMR vaccine: review of benefits and risks. J Infect 44 (2002) 1-6
31. Muscat M., Falkenhorst G., and Bang H. Decline in measles in WHO European Region but rubella remains high. Euro Surveill 10 (2005) E0503243
32. Peltola H., Davidkin I., Paunio M., Valle M., Leinikki P., and Heinonen O.P. Mumps and rubella eliminated from Finland. JAMA 284 (2000) 2643-2647
33. World Health Organization. Global status of mumps immunization and surveillance. Wkly Epidemiol Rec 80 (2005) 418-424
34. Shinefield H.R., Black S., and Kuter B.J. Varicella immunogenicity with 1- and 2-dose regimens of measles-mumps-rubella-varicella vaccine. J Infect Dis 197 Suppl. 2 (2008) S152-S155
35. Hammerschmidt T., Bisanz H., and Wutzler P. Universal mass vaccination against varicella in Germany using an MMRV combination vaccine with a two-dose schedule: an economic analysis. Vaccine 25 (2007) 7307-7312
36. Halperin S.A., Langley J.M., Hesley T.M., Zappacosta P.S., Radley D., Smith B., et al. Safety and immunogenicity of two formulations of a hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae conjugate-hepatitis B vaccine in 15 to 18-month-old children. Hum Vaccine 1 (2005) 245-250
37. Robert Koch Institut. Empfehlungen der Ständigen Impfkommission (STIKO) am Robert Koch-Institut/Stand: Juli 2006. Epidemiol Bull 2006;30:235-54.
38. Centers for Disease Control and Prevention. Notice to readers: licensure of a combined live attenuated measles, mumps, rubella, and varicella vaccine. MMWR Morb Mortal Wkly Rep 54 (2005) 1212-1213
39. Chaves S.S., Gargiullo P., Zhang J.X., Civen R., Guris D., Mascola L., et al. Loss of vaccine-induced immunity to varicella over time. N Engl J Med 356 (2007) 1121-1129
40. Michalik D., LaRussa P., Steinberg S., Wright P., Edwards K.M., and Gershon A. Primary immune failure after 1 dose of varicella vaccine may be the main cause of breakthrough infections in healthy vaccinated children. Proceedings of the 44th annual meeting of the Infectious Diseases Society of America. Toronto, October 12-15 (2006)
41. ACIP. Update: recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding administration of combination MMRV vaccine. MMWR Morb Mortal Wkly Rep 57 (2008) 258-260
42. Crovari P., Gabutti G., Giammanco G., Dentico P., Moiraghi A.R., Ponzio F., et al. Reactogenicity and immunogenicity of a new combined measles-mumps-rubella vaccine: results of a multicentre trial. The Cooperative Group for the Study of MMR vaccines. Vaccine 18 (2000) 2796-2803
43. Ipp M., Cohen E., Goldbach M., and Macarthur C. Effect of choice of measles-mumps-rubella vaccine on immediate vaccination pain in infants. Arch Pediatr Adolesc Med 158 (2004) 323-326
44. Usonis V., Bakasenas V., Chitour K., and Clemens R. Comparative study of reactogenicity and immunogenicity of new and established measles, mumps and rubella vaccines in healthy children. Infection 26 (1998) 222-226
45. Usonis V., Bakasenas V., Kaufhold A., Chitour K., and Clemens R. Reactogenicity and immunogenicity of a new live attenuated combined measles, mumps and rubella vaccine in healthy children. Pediatr Infect Dis J 18 (1999) 42-48
46. Wellington K., and Goa K.L. Measles, mumps, rubella vaccine (Priorix; GSK-MMR): a review of its use in the prevention of measles, mumps and rubella. Drugs 63 (2003) 2107-2126
47. Chiu S.S., and Lau Y.L. Review of the Varilrix varicella vaccine. Expert Rev Vaccines 4 (2005) 629-643
48. Meurice F., De Bouver J.L., Vandevoorde D., Woods S., and Bogaerts H. Immunogenicity and safety of a live attenuated varicella vaccine (Oka/SB Bio) in healthy children. J Infect Dis 174 Suppl. 3 (1996) S324-S329
49. Varis T., and Vesikari T. Efficacy of high-titer live attenuated varicella vaccine in healthy young children. J Infect Dis 174 Suppl. 3 (1996) S330-S334
50. Kreth H.W., Lee B.W., Kosuwon P., Salazar J., Gloriani-Barzaga N., Bock H.L., et al. Sixteen years of global experience with the first refrigerator-stable varicella vaccine (Varilrix). BioDrugs 22 (2008) 387-402
51. Arnedo-Pena A., Puig-Barbera J., Aznar-Orenga M.A., Ballester-Albiol M., Pardo-Serrano F., Bellido-Blasco J.B., et al. Varicella vaccine effectiveness during an outbreak in a partially vaccinated population in Spain. Pediatr Infect Dis J 25 (2006) 774-778
52. Burgess M.A., Cossart Y.E., Wilkins T.D., Botham S., Fearns G., and Chitour K. Varicella vaccination of health-care workers. Vaccine 17 (1999) 765-769
53. Diaz-Mitoma F., Halperin S.A., and Scheifele D. Reactogenicity to a live attenuated varicella vaccine in Canadian children. Can J Infect Dis 11 (2000) 97-101
54. Passwell J.H., Hemo B., Levi Y., Ramon R., Friedman N., and Lerner-Geva L. Use of a computerized database to study the effectiveness of an attenuated varicella vaccine. Pediatr Infect Dis J 23 (2004) 221-226
55. Scheifele D.W., Halperin S.A., and Diaz-Mitoma F. Three-year follow-up of protection rates in children given varicella vaccine. Can J Infect Dis 13 (2002) 382-386
56. Sheffer R., Segal D., Rahamani S., Dalal I., Linhart Y., Stein M., et al. Effectiveness of the Oka/GSK attenuated varicella vaccine for the prevention of chickenpox in clinical practice in Israel. Pediatr Infect Dis J 24 (2005) 434-437
57. Wasi C., Kosuwan P., Sutran S., Dumavibhat B., Kositanont U., Auewarakul U., et al. Immunogenicity and reactogenicity of one or two doses of varicella in healthy non-immune adolescents and adults. 2nd World Congress of Pediatric Infectious Diseases. Manila, Philippines (1999) [Abstract A2.6]
58. Quian J., Ruttimann R., Romero C., Dall'Orso P., Cerisola A., Breuer T., et al. Impact of universal varicella vaccination on 1-year-olds in Uruguay: 1997-2005. Arch Dis Child 93 (2008) 845-850
59. Brown E.G., Furesz J., Dimock K., Yarosh W., and Contreras G. Nucleotide sequence analysis of Urabe mumps vaccine strain that caused meningitis in vaccine recipients. Vaccine 9 (1991) 840-842
60. Miller E., Goldacre M., Pugh S., Colville A., Farrington P., Flower A., et al. Risk of aseptic meningitis after measles, mumps, and rubella vaccine in UK children. Lancet 341 (1993) 979-982
61. Cizman M., Mozetic M., Radescek-Rakar R., Pleterski-Rigler D., and Susec-Michieli M. Aseptic meningitis after vaccination against measles and mumps. Pediatr Infect Dis J 8 (1989) 302-308
62. Tesovic G., Begovac J., and Bace A. Aseptic meningitis after measles, mumps, and rubella vaccine. Lancet 341 (1993) 1541
63. Miller E., Andrews N., Stowe J., Grant A., Waight P., and Taylor B. Risks of convulsion and aseptic meningitis following measles-mumps-rubella vaccination in the United Kingdom. Am J Epidemiol 165 (2007) 704-709
64. Schlipkoter U., Muhlberger N., von Kries R., and Weil J. Surveillance of measles-mumps-rubella vaccine-associated aseptic meningitis in Germany. Infection 30 (2002) 351-355