European Journal of Pediatrics

, Volume 155, Issue 8, pp 706–711 | Cite as

Use of a reformulated Oka strain varicella vaccine (SmithKline Beecham Biologicals/Oka) in healthy children

  • A. Y. S. Tan
  • C. J. Connett
  • G. J. Connett
  • S. C. Quek
  • H. K. Yap
  • F. Meurice
  • B. W. Lee
Preventive Pediatrics And Epidemiology


The first live-attenuated Oka strain varicella vaccines needed to be stored at −20°C. Reformulation of this vaccine by SmithKline Beecham Biologicals has provided a vaccine shelf life of up to 2 years when stored at +2°C to +8°C. In this study the immunogenicity and reactogenicity of two different production lots of this reformulated vaccine at two different titres each, which corresponded to the release and expected expiry titres, were evaluated. A double-blind randomised clinical trial was conducted in healthy children aged from 9 to 24 months. Immunogenicity was assessed by the measurement of varicella specific antibodies in paired serum samples taken before and from 35 to 63 days post vaccination. Reactogenicity was assessed by the evaluation of any untoward reactions occurring up to 42 days post vaccination. In order to assess protective efficacy, parents of these subjects were contacted approximately 6 months after completion of the trial. One hundred and ninety-one subjects were recruited into the study. Of the 181 initially seronegative subjects who completed the trial according to the protocol, 179 showed seroconversion (98.9%). Reactions to the vaccine were minor and observed in 46/191 (24%) of subjects. Rashes were present in 19, fever in 22, and both fever and rashes in 5. Rashes were mainly maculo-papular in nature but were vesicular in 6. Febrile reactions were shortlived. After a 6-month follow up period, attenuated varicella with minor clinical symptoms was diagnosed in 6/52 vacinees who had close contact with natural varicella (attack rate=11.5%).

Key words

Varicella vaccine Children Seroconversion Immunogenicity Reactogenicity 



plaque-forming unit


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  1. 1.
    Andre FE (1985) Worldwide experience with the Oka-strain live varicella vaccine. Postgrad Med J 61 [Suppl 4]: 113–120PubMedGoogle Scholar
  2. 2.
    Asano Y, Nagai T, Miyata T, Yazaki T, Ito S, Yamanishi K, Takahashi M (1985) Long-term protective immunity of recipients of the OKA strain of live varicella vaccine. Pediatrics 75: 667–671PubMedGoogle Scholar
  3. 3.
    Balfour HH (1984) Intravenous acyclovir therapy for varicella in immunocompromised children. J Pediatr 104: 134–136PubMedGoogle Scholar
  4. 4.
    Balfour HH Jr, Kelly JM, Suarez CS, Heussner RC, Englund JA, Crane DD, McGuirt PV, Clemmer AF, Aeppli M (1990) Acyclovir treatment of varicella in otherwise healthy children. J Pediatr 116: 633–639PubMedGoogle Scholar
  5. 5.
    Bernstein HH, Rothstein EP, Pennhridge Pediatric Associates Watson BM, Reisinger KS, Blatter MM, Wellman CO, Chartrand SA, Cho I, Ngai A, White Jo (1993) Clinical survey of natural vaicella compared with breakthrough varicella after immunisation with live attenuated Oka/Merck varicella vaccine. Pediatrics 92: 833–837PubMedGoogle Scholar
  6. 6.
    Brunell PA (1983) Fetal and neonatal varicella-zoster infections. Semin Perinatol 7: 47–56PubMedGoogle Scholar
  7. 7.
    Brunell PA (1987) Varicella-zoster infections. In: Feign RD, Cherry JD (eds) Textbook of pediatric infectious diseases, 2nd edn. WB Saunders, Philadelphia, pp 1602–1607Google Scholar
  8. 8.
    Brunell PA, Geiser CF, Shebab Z, Waugh JE (1982) Administration of live varicella vaccine to children with leukaemia. Lancet II: 1069–1074Google Scholar
  9. 9.
    Communicable disease surveillance in Singapore (1992) Quarantine and Epidemology Department, Ministry of the Environment, Singapore 4: 24–30Google Scholar
  10. 10.
    Creusvaux H (1994) Immunisation of healthy children with the Pasteur-Merieux Serums et vaccins (PMSV) OKA varicella vaccine (VZ-VAX): the French experience. Program of Second International Conference on the Varicella Zoster Virus. VZV Foundation Inc, New York. B3Google Scholar
  11. 11.
    Enders G, Miller E, Cradock-Watson J, Bolley I, Ridehalgh (1994) Consequences of varicella and herpes zoster in pregnancy:prospective study of 1739 cases. Lancet 343: 1547–1550Google Scholar
  12. 12.
    Epidemiology News Bulletin, Singapore (1989) 17: 27–28Google Scholar
  13. 13.
    FDA approves Merck's chicken pox vaccine (1995) SCRIP, No. 2011, p 20Google Scholar
  14. 14.
    Feldman S, Lott L (1987) Varicella in children with cancer: impact of antiviral therapy and prophylaxis. Pediatrics 80: 465–472PubMedGoogle Scholar
  15. 15.
    Gershon AA, Steinberg S, Gelb L, Galasso G, Borkowsky W, LaRussa P, Farrara A (1984) Live attenuated varicella vaccine: efficacy for children with leukaemia in remission. JAMA 252: 355–362PubMedGoogle Scholar
  16. 16.
    Gershon AA, Steinberg S, Gelb L, Galasso G, Borkowsky W, LaRussa P, Farrara A (1985) A multicentre trial of live attenuated varicella vaccine in children with leukemia in remission. Postgrad Med J 61 [Suppl 4]: 73–78Google Scholar
  17. 17.
    Gershon AA, Steinberg SP, La Russa P, Ferrara A, Hammerschlag M, Gelb L, and the NIAID Varicella Vaccine Collaborative Study Group (1988) Immunisation of healthy adults with live attenuated varicella vaccine. J Infect Dis 158 (1): 132–137PubMedGoogle Scholar
  18. 18.
    Gershon AA, Steinberg SP and the Varicella Vaccine Collaborative Study Group (1989) Persistence of immunity to varicella in children with leukeamia immunised with live attenuated varicella vaccine. N Engl J Med 320: 892–897PubMedGoogle Scholar
  19. 19.
    Gray GC, Palinkas LA, Kelly PW (1990) Increasing incidence of varicella hospitalisations in the United States Army and Personnel: are today × s teenagers becoming more susceptible? Should recruits be vaccinated? Pediatrics 86: 867–873PubMedGoogle Scholar
  20. 20.
    Haake DA, Zakowski PC, Haake DL, Bryson YJ (1990) Early treatment of acyclovir for varicella pneumonia in otherwise healthy adults: retrospective controlled study and review. Rev Infect Dis 112: 788–798Google Scholar
  21. 21.
    Hardy I, Gershon A, Steinberg SP, LaRussa P, the Varicella Vaccine Collaborative Study Group (1991) The incidence of zoster after immunisation with live attenuated varicella vaccine. A study in children with leukemia. N Engl J Med 325: 1545–1550PubMedGoogle Scholar
  22. 22.
    Huse DM, Meissner C, Lacey MJ, Oster G (1994) Childhood vaccination against chicken pox: An analysis of benefits and costs. J Pediatr 124: 869–874PubMedGoogle Scholar
  23. 23.
    Leventon-Kriss S, Yoffe R, Rannos L, Modan M (1978) Seroepidemiologic aspects of varicella zoster virus infections in an Israeli Jewish population. Isr J Med Sci 14: 766–770PubMedGoogle Scholar
  24. 24.
    Lewis DA, Jenks P, Gent AEM, Side L, Breuer J (1994) Varicella zoster vaccination for health care workers. Lancet 343: 1362–1363Google Scholar
  25. 25.
    Lieu TA, Cochi SL, Black SB, Halloran E, Shinefield HR, Holmes SJ, Wharton M, Washington E (1994) Cost-effectiveness of a routine varicella vaccination program for US children. JAMA 271: 375–381PubMedGoogle Scholar
  26. 26.
    McIntosh K (1984) Varicella vaccine: decisions a little nearer. N Engl J Med 310: 1456–1457PubMedGoogle Scholar
  27. 27.
    Miller E, Vurdien J, Farrington P (1993) Shift in age in chicken pox. Lancet 341: 308–309Google Scholar
  28. 28.
    Ooi PL, Goh KT, Doraisingham S, Ling AE (1992) Prevalence of varicella-zoster virus infection in Singapore. SE Asean J Trop Med Public Health 23: 22–25Google Scholar
  29. 29.
    Patte C, Mihon J, Meresse V, Leverger G, Philippe N Freycon F, Schaison G, Lemerle S, Teulieres L, Creusvaux H, Lemerle J (1994) Live attenuated varicella vaccine in immunocompromised children treated for malignancies: a French study of the Pasteur-Merieux OKA vaccine in 132 patients. In: Program of Second International Conference on the Varicella Zoster Virus. VZV Foundation Inc, New York. B3Google Scholar
  30. 30.
    Preblud SR (1986) Varicella: complications and costs. Pediatrics 78 [Suppl]: 728–735PubMedGoogle Scholar
  31. 31.
    Takahashi M, Otsuka T, Okuno Y, Asano Y, Yazaki T, Isomura S (1974) Live vaccine used to prevent the spread of varicella in children in hospital. Lancet II: 1288–1290Google Scholar
  32. 32.
    Watson B, Piercy S, Soppas D, Browngoeehl K, Warner M, Isganitis K, White CJ, Kuter B, Chua J, Starr S (1993) The effect of decreasing amounts of live virus, while antigen content remains constant, on immunogenicity of Oka/Merck varicella vaccine. J Infect Dis 168: 1356–1360PubMedGoogle Scholar
  33. 33.
    Watson B, Sharon P, Plotkin SA, Starr SE (1993) Modified chickenpox in children immunised with the Oka/Merck varicella vaccine. Pediatrics 91: 17–22PubMedGoogle Scholar
  34. 34.
    Watson B, Gupta R, Rendall T, Starrs S (1994) Persistence of cell mediated and humoral immune responses in healthy children immunised with live attenuated varicella vaccine. J Infect Dis 169: 197–199PubMedGoogle Scholar
  35. 35.
    Weibel RE, Neff BJ, Kuter BJ, Kuter BJ, Guess HA, Rothenberger CA, Fitzgerald AJ, Connor KA, McLean AA, Hilleman MR, Buynak EB, Scolnick EM (1984) Live attenuated varicella virus vaccine: efficacy trial in healthy children. N Engl J Med 310: 1409–1415PubMedGoogle Scholar
  36. 36.
    White CJ, Kuter BJ, Hildebrand CS, Isgantis KL, Mathews H, Miller WJ, Provost PJ, Ellis RW, Gerety RJ, Calandra GB (1991) Varicella vaccine (Varivax) in healthy children and adolescents: results from clinical trials, 1987 to 1989. Pediatrics 87: 604–620PubMedGoogle Scholar

Copyright information

© Springer-Verlag 1996

Authors and Affiliations

  • A. Y. S. Tan
    • 1
  • C. J. Connett
    • 1
  • G. J. Connett
    • 1
  • S. C. Quek
    • 1
  • H. K. Yap
    • 1
  • F. Meurice
    • 2
  • B. W. Lee
    • 1
  1. 1.Department of PaediatricsNational University of SingaporeSingapore
  2. 2.SmithKline Beecham BiologicalsRixensartBelgium

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