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Description
  • This randomized (1:1), double-blind, multicenter study, included 4,968 healthy infants to receive either the 11-valent pneumococcal protein D (PD)-conjugate study vaccine or the hepatitis A vaccine (HAV) (control) at 3, 4, 5, and 12-15 months of age. The three-dose primary course of both vaccines was co-administered with combined hexavalent DTPa-HBV-IPV/Hib vaccine. The pneumococcal PD-conjugate study vaccine did not impact the immune response of co-administered hexavalent vaccine and the control HAV vaccine induced seropositivity (antibodies >or=15 mIU/mL) in all infants. The incidence of solicited symptoms was higher with the 11-valent pneumococcal PD-conjugate study vaccine, yet similar to that induced by concomitant DTPa-HBV-IPV/Hib vaccine. Overall, the reactogenicity and safety profile of the 11-valent pneumococcal PD-conjugate vaccine when co-administered with the hexavalent DTPa-HBV-IPV/Hib vaccine, as well as the immunogenicity of the co-administered hexavalent vaccine, were consistent wit
  • This randomized (1:1), double-blind, multicenter study, included 4,968 healthy infants to receive either the 11-valent pneumococcal protein D (PD)-conjugate study vaccine or the hepatitis A vaccine (HAV) (control) at 3, 4, 5, and 12-15 months of age. The three-dose primary course of both vaccines was co-administered with combined hexavalent DTPa-HBV-IPV/Hib vaccine. The pneumococcal PD-conjugate study vaccine did not impact the immune response of co-administered hexavalent vaccine and the control HAV vaccine induced seropositivity (antibodies >or=15 mIU/mL) in all infants. The incidence of solicited symptoms was higher with the 11-valent pneumococcal PD-conjugate study vaccine, yet similar to that induced by concomitant DTPa-HBV-IPV/Hib vaccine. Overall, the reactogenicity and safety profile of the 11-valent pneumococcal PD-conjugate vaccine when co-administered with the hexavalent DTPa-HBV-IPV/Hib vaccine, as well as the immunogenicity of the co-administered hexavalent vaccine, were consistent wit (en)
  • Tato randomizovaná (1:1) dvojitě slepá, multicentrická studie, zahrnovala 4968 zdravých kojenců, kteří obdrželi buď 11ti valentní penumokokovou konjugovanou vakcínu na protein D (PD) nebo vakcín proti hepatitidě A (HAV) (kontrola) v měsíci 3, 4, 5 a 12-15. Tří-dávkové primární schéma obou vakcín bylo koadministrováno s kombinovanou hexavalentní vakcínou TTPa - HPV - IPV/Hib. Pneumokoková konjugovaná vakcína na PD neovlivnila imunitní odpověď spolupodané hexavalentní vakcíny a kontrolní vakcínou proti HAV indukovanou seropozitivitu (protilátky větší nebo rovno 15 mIU/mL) u žádného dítěte. Incidence vybraných simptomů byla vyšší u 11ti valentní penumokokové konjugované vakcíny na PD i když podobná incidenci indukované spolupodanou vakcínou proti TTPa - HPV - IPV/Hib. Celkově reaktogenita a bezpečnostní profil 11ti valentní pneumokokové konjugované PD vakcíny, když je spolupodána hexavalentní TTPa - HPV - IPV/Hib vakcínou, jakož i imunogenita spolupodané hexavalentní vakcíny byla konzistentní s předcháze (cs)
Title
  • Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus influenzae-derived protein D in the first 2 years of life and immunogenicity of the co-administered dexavalent diphtheria, tetanus, acellular pertussis, hepatits B
  • Bezpečnost 11valentní pneumokokové vakcíny konjugované na D protein derivovaný z netypovatelných haemophylus influenzae v prvních dvou letech života a imunogenita spolupodané hexavalentní vakcíny proti diftérii tetanu acelulární pertusi hepatitis B in (cs)
  • Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus influenzae-derived protein D in the first 2 years of life and immunogenicity of the co-administered dexavalent diphtheria, tetanus, acellular pertussis, hepatits B (en)
skos:prefLabel
  • Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus influenzae-derived protein D in the first 2 years of life and immunogenicity of the co-administered dexavalent diphtheria, tetanus, acellular pertussis, hepatits B
  • Bezpečnost 11valentní pneumokokové vakcíny konjugované na D protein derivovaný z netypovatelných haemophylus influenzae v prvních dvou letech života a imunogenita spolupodané hexavalentní vakcíny proti diftérii tetanu acelulární pertusi hepatitis B in (cs)
  • Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus influenzae-derived protein D in the first 2 years of life and immunogenicity of the co-administered dexavalent diphtheria, tetanus, acellular pertussis, hepatits B (en)
skos:notation
  • RIV/60162694:G44__/08:00001959!RIV09-MO0-G44_____
http://linked.open...avai/riv/aktivita
http://linked.open...avai/riv/aktivity
  • Z(MO0FVZ0000502)
http://linked.open...iv/cisloPeriodika
  • 35
http://linked.open...vai/riv/dodaniDat
http://linked.open...aciTvurceVysledku
http://linked.open.../riv/druhVysledku
http://linked.open...iv/duvernostUdaju
http://linked.open...titaPredkladatele
http://linked.open...dnocenehoVysledku
  • 393701
http://linked.open...ai/riv/idVysledku
  • RIV/60162694:G44__/08:00001959
http://linked.open...riv/jazykVysledku
http://linked.open.../riv/klicovaSlova
  • Pneumococcal protein D; conjugate/DTPa-HBV-IPV/Hib combination; vaccines; immunogenicity (en)
http://linked.open.../riv/klicoveSlovo
http://linked.open...odStatuVydavatele
  • GB - Spojené království Velké Británie a Severního Irska
http://linked.open...ontrolniKodProRIV
  • [30F757DCA83A]
http://linked.open...i/riv/nazevZdroje
  • Vaccine
http://linked.open...in/vavai/riv/obor
http://linked.open...ichTvurcuVysledku
http://linked.open...cetTvurcuVysledku
http://linked.open...UplatneniVysledku
http://linked.open...v/svazekPeriodika
  • 26
http://linked.open...iv/tvurceVysledku
  • Chlíbek, Roman
  • Špliňo, Miroslav
  • Kalíšková, Eva
  • Lommel, Patricia
  • Prymula, Roman
  • Kohl, Igor
  • Schuerman, lode
http://linked.open...ain/vavai/riv/wos
  • 000258971800024
http://linked.open...n/vavai/riv/zamer
issn
  • 0264-410X
number of pages
http://localhost/t...ganizacniJednotka
  • G44
is http://linked.open...avai/riv/vysledek of
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