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immunogenicitetsdata
immunogenicity data

yderligere immunogenicitetsdata
additional immunogenicity data

4.3. immunogenicitetsdata hos præmature spædbørn
4.3. immunogenicity data in preterm infants

der blev evalueret immunogenicitetsdata for 64 forsøgspersoner.
immunogenicity data were evaluated in 64 subjects.

immunogenicitetsdata fra bo22334/sabrina og bo25341/sawyer
immunogenicity data from bo22334/sabrina and

immunogenicitetsdata er stærkt afhængige af analysens sensitivitet og specificitet.
immunogenicity data are highly dependent on the sensitivity and specificity of the assay.

sikkerheds- og immunogenicitetsdata hos raske voksne, inklusive ældre.
safety and immunogenicity data in healthy adults, including older people.

immunogenicitetsdata er meget afhængige af følsomheden og specificiteten af ada-analysen.
immunogenicity data are highly dependent on the sensitivity and specificity of the ada assay.

doseringsanbefalingerne er baseret på sikkerheds- og immunogenicitetsdata fra kliniske studier med raske forsøgspersoner.
the dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects.

på basis af disse immunogenicitetsdata konkluderes det, at cervarix har effekt hos aldersgruppen fra 9 til 14 år.
on the basis of these immunogenicity data, the efficacy of cervarix is inferred from 9 to 14 years of age.

immunogenicitetsdata, indhentet tre uger efter en dosis focetria h1n1v, indikerer, at en enkelt dosis kan være tilstrækkeligt.
immunogenicity data obtained at three weeks after one dose of focetria h1n1v suggest that a single dose may be sufficient.

der er begrænsede sikkerheds- og immunogenicitetsdata tilgængelige for administration af adjupanrix og for administration af halv vaccinedosis (dvs.
there are limited safety and immunogenicity data available on the administration of adjupanrix and on administration of half a dose of the vaccine (i.e.

begrænsede sikkerheds- og immunogenicitetsdata opnået efter administration af to doser til raske voksne i alderen 18-60 år.
limited safety and immunogenicity data obtained after administration of two doses to healthy adults aged 18-60 years.

begrænsede sikkerheds- og immunogenicitetsdata opnået tre uger efter administration af en enkelt dosis til raske voksne i alderen 18-79 år.
limited safety and immunogenicity data obtained three weeks after administration of a single dose to healthy adults aged 18-79 years.

begrænsede immunogenicitetsdata opnået tre uger efter administration af en enkelt dosis 0,25 ml eller 0,5 ml til raske børn i alderen 10-17 år.
limited immunogenicity data obtained three weeks after administration of a single dose of 0.25 ml or 0.5 ml to healthy children aged 10-17 years.

denne indikation er baseret på immunogenicitetsdata fra personer i alderen 6 måneder og derover efter administration af to vaccinedoser, der er fremstillet med h5n1-subtypestammer (se pkt.
this indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with h5n1 subtype strains (see section 5.1).

foruden af de immunogenicitetsdata, der de seneste 5 år er genereret i kliniske undersøgelser med hbvaxpro og procomvax, bekræftes vaccinernes tilfredsstillende virkning af overvågningsresultater vedrørende hepatitis b i usa og new zealand og af en trend- analyse af
in addition to the immunogenicity data generated in the past 5 years from clinical trials with the procomvax data, the acceptable performance of these vaccines are supported from findings of surveillance for hepatitis b cases in the united states and new zealand and from an analysis of the trend in vaccine failures reported to the mah safety database.

kliniske studier af prevenar 13 har for nylig leveret immunogenicitetsdata for voksne over 18 år, herunder voksne over 65 år, som tidligere er blevet vaccineret med en eller flere doser af 23-valent pneumokok polysaccharidvaccine 5 år før inklusion i studiet.
clinical studies with prevenar 13 currently provide immunogenicity data in adults aged 18 years and older, including adults aged 65 and older previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine, 5 years prior to enrollment.

immunogenicitetsdata for subkutan anvendelse af silapo hos patienter med risiko for antistof - fremkaldt pure red cell aplasia (prca), dvs. patienter med renal anæmi, er ikke tilstrækkelige.
immunogenicity data for subcutaneous use of silapo in patients at risk for antibody-induced pure red cell aplasia (prca), i. e. patients with renal anaemia, are not sufficient.