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  • Title: BCG vaccination of neonates, infants, schoolchildren and adolescents. Part II: Safety of a vaccine with strain 1331 Copenhagen.
    Author: Lehmann HG, Engelhardt H, Freudenstein H, Hennessen W, Quast U, Widmark RM.
    Journal: Dev Biol Stand; 1979; 43():133-6. PubMed ID: 520665.
    Abstract:
    The safety of the vaccine could be assessed by three different investigations: a) During the dose finding study (part I) the vaccine showed good safety in all concentrations employed concerning reactions at the site of injection; palpable lymph node enlargement was common. There was one case of suppurative lymphadenitis amond the 262 children who were given the vaccine in the highest concentration (25 X 10(4) VU). b) Subsequent trials in the course of 21 months, when high risk persons could be vaccinated, revealed a rate of this complication in the 1:1,000 range, no case was reported among older persons. c) After the official approval of the vaccine (10 - 30 X 10(4) VU/ml) in the FRG 1 supp. lymphadenitis among 5,000 vaccinated newborns can be calculated.
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