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Immunogenicity, reactogenicity and consistency of a new, inactivated hepatitis A vaccine--a randomized multicentre study with three consecutive vaccine lots.
Kallinowski, B; Gmelin, K; Kommerell, B; Bock, H L; Clemens, R; Scheiermann, N; Wohland, B; Hofmann, F; Theilmann, L.
Afiliación
  • Kallinowski B; University Hospital of Heidelberg, Department of Internal Medicine IV, Germany.
Vaccine ; 10(8): 500-1, 1992.
Article en En | MEDLINE | ID: mdl-1320306
We investigated immunogenicity, reactogenicity and consistency of three consecutive lots of an inactivated hepatitis A vaccine in 204 seronegative volunteers. Each volunteer received a total of three doses of vaccine (720 EIU) according to a 0, 1 month primary vaccination schedule with a booster dose given at month 6. Mild, moderate and mostly local side effects were reported in 49.7% after the first and in less than 30% after the third injection. Seroconversion rate after one vaccine dose was as high as 91%. All subjects but one had already seroconverted by 1 month after the second injection, corresponding to a seroconversion rate of 99%. The geometric mean titres (GMT) increased with each dose of vaccine administered. Our results show that this inactivated hepatitis A vaccine is highly immunogenic, safe and well tolerated. Furthermore, there were no significant differences between the three vaccine lots in respect to seroconversion rate, size of antibody titre or reactogenicity.
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas Virales / Hepatovirus Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Vaccine Año: 1992 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Países Bajos
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas Virales / Hepatovirus Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Vaccine Año: 1992 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Países Bajos