FrancophonIA/ELRC3.0 huggingface dataset:
English: The percentage of vaccinees reaching the threshold for the three additional serotypes in Synflorix (1, 5 and 7F) was respectively 97.3%, 99.0% and 99.5% and was at least as good as the aggregate 7-valent Prevenar response against the 7 common serotypes (95.8%).
Danish: Den procentdel af de vaccinerede, der opnåede tærskelværdien for de tre ekstra serotyper i Synflorix (1, 5 og 7F), var hhv. 97,3 %, 99,0 % og 99,5 %, hvilket var mindst lige så godt som det akkumulerede 7-valent Prevenar-respons på de 7 fælles serotyper (95,8 %).
English: 9-16 micrograms
Danish: 9-16 mikrogram
English: • itching, blood clot, bleeding or a small lump where the injection is given
Danish: • kløe, blodprop, blødning eller en lille bule på administrationsstedet
English: Long-term persistence of antibodies has not been investigated after administration of a primary series in infants plus booster or after a 2-dose priming in older children.
Danish: Den vedvarende langtidseffekt af antistoffer er ikke undersøgt efter administration af primærprogrammerne plus boostervaccination af spædbørn eller efter primærvaccination af større børn med 2 doser.
English: If not used within 28 days it should be discarded.
Danish: Vaccinen skal kasseres, hvis den ikke er anvendt inden for 28 dage.
English: CONDITIONS FOR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OF EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: The clinical data suggest that paracetamol might reduce the immune response to Synflorix.
Danish: De kliniske data tyder på, at paracetamol kan nedsætte immunresponset af Synflorix.
English: The clinical consequences of the lower post-primary and post-booster immune responses observed after the 2-dose primary schedule are not known.
Danish: De kliniske konsekvenser af det lavere post-primære og post-booster immunrespons efter vaccinationsprogram med 2 doser er ikke kendt.
English: • In children aged 2 to 5 years that received 1 dose, the ELISA antibody GMCs were similar for 6 vaccine serotypes as well as serotype 19A than those achieved following a 3-dose vaccination schedule in infants below 6 months of age while they were lower for 4 vaccine serotypes (serotypes 1, 5, 14 and 23F).
Danish: • Hos børn i alderen 2-5 år, som fik 1 dosis, var ELISA-antistof-GMC sammenlignelig for 6 vaccineserotyper samt for serotype 19A i forhold til, hvad der blev opnået efter et 3-dosis vaccinationsprogram hos spædbørn i alderen under 6 måneder, mens de var lavere for 4 vaccineserotyper (serotype 1, 5, 14 og 23F).
English: The clinical relevance of these differences is unclear, as Synflorix was observed to be effective against IPD caused by serotype 6B in a doubleblind, cluster-randomized clinical study (see Table 1).
Danish: Den kliniske relevans af disse forskelle er uklar, da det i et dobbeltblindet, center-randomiseret klinisk studie blev observeret, at Synflorix var effektiv mod IPD forårsaget af serotype 6B (se tabel 1).
English: The estimated vaccine efficacy against any clinical episodes of otitis media regardless of aetiology was 33.6% (95% CI: 20.8;
Danish: Vaccinens estimerede effekt mod alle kliniske tilfælde af otitis media uanset ætiologi var 33,6 % (95 % CI 20,8;44,3).
English: Uncommon Headache (age 2 to 5 years)
Danish: Hovedpine (hos børn 2-5 år)
English: The OPA GMTs were similar or higher following a single dose than a 3-dose primary course in infants below 6 months of age, except for serotype 5.
Danish: OPA-GMT var sammenlignelig eller højere efter en enkelt dosis end efter et 3-dosis primærprogram hos spædbørn i alderen under 6 måneder, bort set fra serotype 5.
English: As with any vaccine, Synflorix may not protect all vaccinated individuals against invasive pneumococcal disease, pneumonia or otitis media caused by the serotypes in the vaccine and the cross-reactive serotype 19A.
Danish: I lighed med andre vacciner beskytter Synflorix ikke nødvendigvis alle vaccinerede personer mod invasiv pneumokoksygdom, pneumoni eller otitis media forårsaget af de serotyper, som indgår i vaccinen og den krydsreaktive serotype 19A.
English: This bacteria can cause serious illnesses including meningitis, sepsis and bacteraemia (bacteria in blood stream) as well as ear infection or pneumonia.
Danish: Disse bakterier kan forårsage alvorlige sygdomme, f.eks. hjernehindebetændelse (meningitis), blodforgiftning og bakterier i blodet (bakteriæmi) samt mellemørebetændelse og lungebetændelse.
English: • high temperature of 38° C or higher (fever)
Danish: • høj feber (38 °C eller mere)
English: (≥1/10,000 to <1/1,000)
Danish: (≥ 1/10.000 til < 1/1.000)
English: Uncommon Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Danish: Apnø hos meget præmature spædbørn (≤ 28 svangerskabsuger) (se pkt.
English: GlaxoSmithKline Biologicals S.A. Parc de la Noire Epine Rue Fleming 20
Danish: GlaxoSmithKline Biologicals S.A. Parc de la Noire Epine Rue Flemming 20
English: The antibody GMCs and OPA GMTs were lower after 2-dose for most vaccine serotypes.
Danish: Antistof GMCs og OPA GMT var lavere efter 2-dosisprogram for de fleste af vaccinens serotyper.
English: • In children aged 12-23 months, the immune responses elicited after two doses were comparable to the responses elicited after three doses in infants below 6 months of age, except for vaccine serotypes 18C and 19F as well as serotype 19A for which responses were higher in the 12-23 months children.
Danish: • Hos børn i alderen 12-23 måneder var immunresponset, som 2 doser fremkaldte, sammenligneligt med det respons, som 3 doser fremkaldte hos spædbørn i alderen under 6 måneder, undtagen for vaccineserotyperne 18C og 19F samt for serotype 19A, hvis respons var højere hos børn i 12-23 månedersalderen.
English: Synflorix may not work as well if your child is taking medicines that affect the immune system to fight infection.
Danish: Synflorix giver muligvis ikke fuld beskyttelse, hvis dit barn får medicin, som påvirker immunforsvaret (kroppens forsvar mod infektioner).
English: Immune responses were compared using non-inferiority criteria in terms of antibody GMC ratio (GMC from group of subjects receiving Synflorix without 2-PE over GMC from group of subjects receiving Synflorix with 2-PE) for each of the 10 vaccine serotypes and for the cross-reactive serotype 19A.
Danish: Immunresponset blev sammenlignet ved non-inferioritet kriterier i forhold til antistof GMC ratio (GMC fra gruppen af personer der fik Synflorix uden 2-PE, over GMC fra gruppen af personer der modtog Synflorix med 2-PE) for hver af de 10 serotyper i vaccinen og for den krydsreaktive serotype 19A.
English: In infants, the most common adverse reactions observed after primary vaccination were redness at the injection site and irritability which occurred after approximately 41% and 55% of all doses respectively.
Danish: De almindeligste bivirkninger hos spædbørn, som blev set efter primærvaccination, var rødme på administrationsstedet og irritabilitet, som sås efter hhv. ca. 41 % og 55 % af alle doser.
English: The vaccine is for intramuscular use only.
Danish: Vaccinen er til intramuskulær anvendelse.
English: For C-CAP it was 15.1% (95% CI: -15.5; 37.6) and 26.3% (95% CI: 4.4; 43.2) respectively.
Danish: For C-CAP var den henholdsvis 15,1 % (95 % CI -15,5; 37,6) og 26,3 % (95 % CI 4,4; 43,2).
English: This is usually in the thigh or upper arm.
Danish: Normalt gives vaccinen i låret eller overarmen.
English: CONDITIONS OR RESTRICTIONS REGARDING SYPPLY AND USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: However if your child has received paracetamol before or immediately after Synflorix is given, the obtained levels of antibodies may be slightly reduced.
Danish: Dog, hvis dit barn har fået paracetamol før eller lige efter Synflorix, vil niveauet af antistoffer mod pneumokok-sygdom, som dit barn opnår, muligvis være en smule lavere end ellers.
English: Very common Fever ≥ 38 °C rectally (age < 2 years), pain, redness, swelling at the injection site.
Danish: Meget almindelig Feber ≥ 38 °C rektalt (hos børn < 2 år), smerter, rødme, hævelse på administrationsstedet
English: Clinical data suggest that prophylactic administration of paracetamol, used to reduce the rate of possible post-vaccination febrile reactions, might reduce the immune response to Synflorix.
Danish: Kliniske data tyder på, at profylaktisk administration af paracetamol, der anendes til at reducere frekvensen af mulige febrile reaktioner efter vaccinen, kan reducere immunresponset til Synflorix.
English: Invasive pneumococcal disease (which includes sepsis, meningitis, bacteraemic pneumonia and bacteraemia)
Danish: Invasiv pneumokoksygdom (omfattende sepsis, meningitis, bakteriæmisk pneumoni og bakteriæmi)
English: For most vaccine serotypes and serotype 19A, group comparisons did not suggest any differences post-booster dose in ELISA antibody GMCs and OPA GMTs between the HIV+/+ and HIV-/- groups, or the HIV+/- and HIV-/- groups.
Danish: For de fleste af vaccinens serotyper og serotype 19A, viste en gruppe sammenligning ikke nogen forskel på ELISA antistof GMCs og OPA GMTs efter booster dosis, mellem grupperne hiv +/+ og hiv -/-, eller for grupperne hiv +/- og hiv -/-.
English: For the cross-reactive serotype 19A, similar percentages of subjects reaching antibody threshold and OPA titres ≥ 8 and similar antibody GMC and OPA GMT were observed post-primary in both groups.
Danish: For den krydsreaktive serotype 19A, var der lignende procentdele af personer der opnåede tærskelværdi for antistof og OPA titer ≥ 8, og lignende antistof GMC og OPA GMT blev observeret efter primær vaccination for begge grupper.
English: In the nested Finnish study, a significant reduction was also observed for individual serotypes 14, 23F and, in the 3 dose primary schedule, for the cross-reactive serotype 19A.
Danish: I det finske undestudie blev der yderligere set en signifikant reduktion af de individuelle serotyper 14 og 23F, samt af den krydsreaktive serotype 19A i 3-dosis primærvaccinationsprogrammet.
English: Type of IPD
Danish: IPD-type
English: Children with a weakened immune system (such as due to human immunodeficiency virus (HIV) infection or immunosuppressive therapy) may not get the full benefit from Synflorix.
Danish: Børn med nedsat immunforsvar (f.eks. pga. human immundefekt virus (hiv) infektion eller immunhæmmende behandling) får muligvis ikke fuld beskyttelse af Synflorix.
English: (≥1/1,000 to <1/100)
Danish: (≥ 1/1.000 til < 1/100)
English: In a head-to-head comparative trial with 7-valent Prevenar, non-inferiority of the immune response to Synflorix measured by ELISA was demonstrated for all serotypes, except for 6B and 23F (upper limit of the 96.5% CI around the difference between groups >10%) (Table 6).
Danish: I et direkte sammenlignende studie med 7-valent Prevenar opnåede immunresponset non-inferioritet, målt med ELISA, for alle serotyper undtagen 6B og 23F (den øvre grænse for CI 96,5 % for forskel på Prevenar og Synflorix oversteg 10 %) (tabel 6).
English: Immunogenicity of Synflorix containing the preservative 2-PE (presented in a 4-dose container) was assessed in healthy infants vaccinated at 6, 10 and 18 weeks of age and compared to those receiving Synflorix without added preservative (160 enrolled subjects per group).
Danish: Immunogenicitet for Synflorix der indeholder konserveringsmidlet 2-PE (tilsat i flerdosisbeholderen med 4 doser) er vurderet hos raske spædbørn vaccineret ved 6-, 10- og 18-ugersalderen, og sammenlignet med spædbørn vaccineret med Synflorix uden tilsat konserveringsmiddel (160 personer inkluderet i hver gruppe).
English: There was no impact of co-administration on the other nine pneumococcal serotypes.
Danish: Der sås ingen påvirkning af de øvrige ni pneumokokserotyper efter samtidig administration.
English: Based on almost 3 years of surveillance following Synflorix introduction, a matched case-control study reported a significant decrease in culture or PCR confirmed IPD due to any vaccine serotype, and IPD due to individual serotypes 6B, 14 and 19A.
Danish: Baseret på næsten 3 års overvågning efter introduktion af Synflorix rapporterede et sammenlignende case-kontrol studie et signifikant fald i IPD, som skyldtes alle vaccineserotyper, bekræftet ved dyrkning eller PCR, og IPD, som skyldtes serotyperne 6B, 14 og 19A.
English: For serotypes 1, 5 and 7F, the percentages of Synflorix vaccinees reaching an OPA titre ≥ 8 were respectively 65.7%, 90.9% and 99.6% after the primary vaccination course and 91.0%, 96.3% and 100% after the booster dose.
Danish: For serotype 1, 5 og 7F var procentdelen af de Synflorix-vaccinerede, der opnåede en OPA-titer på ≥ 8, hhv. 65,7 %, 90,9 % og 99,6 % efter det primære vaccinationsprogram og 91,0 %, 96,3 % og 100 % efter boosterdosis.
English: The OPA response for serotypes 1 and 5 was lower in magnitude than the response for each of the other serotypes.
Danish: OPA-responset for serotype 1 og 5 var lavere end responset for alle af de andre serotyper.
English: In a clinical study NPC was assessed in HIV positive infants (N = 83) and HIV negative infants born from HIV positive mothers (N = 101) and compared to HIV negative infants born from HIV negative mothers (N = 100).
Danish: I et klinisk studie blev nasofaryngal bærertilstand vurderet hos hiv-positive spædbørn (N = 83) og hos hiv-negative spædbørn født af hiv-positive mødre (N = 101), og sammenlignet med hiv-negative spædbørn født af hiv-negative mødre (N = 100).
English: Enhancement of antibody response to Hib-TT conjugate, diphtheria and tetanus antigens was observed.
Danish: Der sås en forøgelse af antistofresponset over for Hib-TT-konjugat, difteriog tetanus-antigener.
English: The immune responses after the booster dose in this age group were generally similar to those observed after the booster dose in infants who had been primed with 3 doses below 6 months of age.
Danish: Immunresponset efter boosterdosis i denne aldersgruppe var generelt sammenlignelig med det respons, der blev observeret efter boosterdosis hos spædbørn, som havde fået primærprogrammet med tre doser, før de var 6 måneder gamle.
English: If not used immediately, the vaccine should be stored in a refrigerator (2 °C - 8 °C).
Danish: Hvis den ikke anvendes straks, skal vaccinen opbevares i køleskab (2 °C - 8 °C).
English: No. of IPD cases
Danish: Antal IPD-tilfælde
English: Store in the original package in order to protect from light After first use, the product may be stored in a refrigerator for a maximum of 28 days
Danish: Opbevares i den originale yderpakning for at beskytte mod lys Efter anbrud kan vaccinen opbevares i maksimalt 28 dage i køleskab.
English: OPA GMTs were observed for all infants except lower antibody GMCs for serotypes 4, 5, 9V and the cross-reactive serotype 19A in very preterms and serotype 9V in preterms and lower OPA GMT for serotype 5 in very preterms.
Danish: Sammenlignelige antistof-GMC og OPA-GMT blev set hos alle spædbørn, bortset fra lavere antistof-GMC for serotyperne 4, 5, 9V og den krydsreaktive serotype 19A hos meget præmature spædbørn, og for serotype 9V hos præmature spædbørn, samt en lavere OPA-GMT for serotype 5 hos meget præmature spædbørn.
English: In a large-scale phase III, randomized, double-blind clinical trial (Clinical Otitis Media and Pneumonia Study - COMPAS) conducted in Argentina, Panama and Colombia, healthy infants aged 6 to 16 weeks received either Synflorix or hepatitis B control vaccine at 2, 4 and 6 months of age followed respectively by either Synflorix or hepatitis A control vaccine at 15 to 18 months of age.
Danish: I et stort fase III, randomiseret, dobbeltblindet klinisk studie (Clinical Otitis Media and Pneumonia Study - COMPAS), udført i Argentina, Panama og Colombia, fik raske børn i alderen 6-16 uger enten Synflorix eller hepatitis B-kontrolvaccine ved 2-, 4- og 6-månedersalderen efterfulgt af henholdsvis Synflorix eller hepatitis A-kontrolvaccine ved 15-18-månedersalderen.
English: EU/1/09/508/001 - pack of 1 without needle EU/1/09/508/002 - pack of 10 without needle EU/1/09/508/003 - pack of 1 with 1 needle EU/1/09/508/004 - pack of 10 with 10 needles EU/1/08/508/005 - pack of 1 with 2 needles EU/1/09/508/010 - pack of 50 without needle
Danish: EU/1/09/508/001 - pakningsstørrelse på 1 uden kanyle EU/1/09/508/002 - pakningsstørrelse på 10 uden kanyle EU/1/09/508/003 - pakningsstørrelse på 1 med 1 kanyle EU/1/09/508/004 - pakningsstørrelse på 10 med 10 kanyler EU/1/09/508/005 - pakningsstørrelse på 1 med 2 kanyler EU/1/09/508/010 - pakningsstørrelse på 50 uden kanyle
English: The functional immune response to serotypes 1 and 5 was lower in magnitude than the response against all other vaccine serotypes.
Danish: Det funktionelle immunrespons for serotype 1 og 5 var lavere end responset for de øvrige vaccineserotyper.
English: • nausea, diarrhoea or feeling sick (vomiting)
Danish: • kvalme, diarré eller opkastning
English: • Each injection will be given at least one month apart except for the last injection (booster),
Danish: • Der skal være mindst en måned mellem hver indsprøjtning bortset fra den sidste indsprøjtning
English: Common (these may occur with up to 1 in 10 doses of the vaccine) • hardness where the injection is given
Danish: Almindelige (kan forekomme ved op til 1 ud af 10 vaccinedoser): • hårdhed på administrationsstedet.
English: Use with systemic immunosuppressive medicinal products
Danish: Samtidig anvendelse med systemiske immunsuppressiva
English: For each of the seven serotypes in common, 87.7% to 100% of Synflorix vaccinees and 92.1% to 100% of 7-valent Prevenar vaccinees reached an OPA titre ≥ 8 one month after the third dose.
Danish: For hver af de 7 fælles serotyper opnåede 87,7-100 % af de Synflorix-vaccinerede og 92,1-100 % af de 7valent Prevenar-vaccinerede en OPA-titer [Opsonophagocytic assay] på ≥ 8 en måned efter den tredje dosis.
English: Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age.
Danish: Aktiv immunisering af spædbørn og børn i alderen fra 6 uger og op til 5 år mod invasiv sygdom, pneumoni og akut otitis media forårsaget af Streptococcus pneumoniae.
English: In the follow-up of the European study evaluating the 2-dose and 3-dose primary vaccination schedules, the persistence of antibodies at 36-46 months of age was demonstrated in subjects that had received a 2-dose primary series followed by a booster dose with at least 83.7% of subjects remaining seropositive for vaccine serotypes and the cross-reactive serotype 19A.
Danish: Ved opfølgningen af det europæiske studie, som evaluerede 2-dosis og 3-dosisprimærvaccinationsprogrammerne, blev persistensen af antistoffer ved 36-46 måneders alderen påvist ved, at mindst 83,7 % af de børn, som var blevet primærvaccineret med 2 doser efterfulgt af en boosterdosis, forblev seropositive over for serotyperne i vaccinen og den krydsreaktive serotype 19A.
English: • The first injection may be given from the age of 6 weeks onwards.
Danish: • Den første indsprøjtning må gives, når dit barn er 6 uger og derover.
English: Safety of Synflorix was assessed in 83 HIV positive (HIV+/+) infants (asymptomatic or with mild symptoms according to WHO classification), 101 HIV negative infants born from HIV positive mothers (HIV+/-) and 50 infants with sickle cell disease (SCD), receiving primary vaccination.
Danish: Sikkerhed for Synflorix blev vurderet hos 83 hiv-positive (hiv+/+) spædbørn (asymptomatiske eller med lette symptomer i henhold til WHO klassifikation), hos 101 hiv-negative spædbørn født af hivpositive mødre (hiv+/-) og hos 50 spædbørn med seglcellesygdom (SDC), som fik den primære vaccination.
English: Table 6: Comparative analysis between 7-valent Prevenar and Synflorix in percentage of subjects with antibody concentrations > 0.20 µg/ml one month post-dose 3
Danish: Tabel 6: Sammenlignende analyse mellem 7-valent Prevenar og Synflorix, angivet som procent af de vaccinerede personer med en antistofkoncentration > 0,20 µg/ml en måned efter tredje dosis.
English: - children aged 12 months -5 years: The vaccination schedule consists of two doses of 0.5 ml with an interval of at least 2 months between doses.
Danish: - børn i alderen 12 måneder-5 år: Vaccinationsprogrammet består af to doser på hver 0,5 ml med et interval på mindst 2 måneder mellem doserne.
English: Overall, the pre-booster persistence of immune responses was lower in the 2-dose compared to the 3-dose priming group for most vaccine serotypes and was similar for serotype 19A.
Danish: Samlet set var persistensen af immunresponset inden boosterdosis lavere i 2-dosisprogrammet for de fleste af vaccinens serotyper, sammenlignet med gruppen der blev primær vaccineret med 3dosisprogrammet, og det var ens for serotype 19A.
English: Similar antibody GMCs and OPA GMTs were observed for all infants except a lower OPA GMT for serotype 5 in very preterm infants.
Danish: Sammenlignelige antistof-GMC og OPA-GMT blev set hos alle spædbørn, bortset fra lavere OPA-GMT for serotype 5 hos meget præmature spædbørn.
English: Severe allergic reactions may very rarely occur (with up to 1 in 10,000 doses of the vaccine).
Danish: Alvorlige allergiske reaktioner kan meget sjældent forekomme (ved op til 1 ud af 10.000 vaccinedoser).
English: There is insufficient evidence that Synflorix provides protection against pneumococcal serotypes not contained in the vaccine except the cross-reactive serotype 19A (see section 5.1) or against nontypeable Haemophilus influenzae.
Danish: Der er utilstrækkelig bevis for, at Synflorix giver beskyttelse mod pneumokokserotyper, som ikke indgår i vaccinen, bortset fra den krydsreaktive serotype 19A (se pkt.
English: In addition when the meningococcal serogroups A, C, W-135 and Y vaccine (TT conjugate) was coadministered with a booster dose of Synflorix during the second year of life in children primed with 3 doses of Synflorix, lower antibody geometric mean concentration (GMC) and opsonophagocytic assay geometric mean titre (OPA GMT) were observed for one pneumococcal serotype (18 C).
Danish: Ved samtidig administration af en meningokokgruppe A, C, W-135 og Y-vaccine (TT-konjugeret) og en boosterdosis af Synflorix i det andet leveår til børn, som tidligere havde fået 3 doser Synflorix som primær vaccination, blev der for en af pneumokokserotyperne (18 C) set lavere antistof-geometrisk middelkoncentration (GMC) og lavere geometrisk-middeltiterværdier (OPA-GMT) bestemt ved opsonofagocytisk analyse.
English: For catch-up vaccination, vaccine effectiveness was 33.2% (95% CI: 3.0; 53.4) in the 7-11 month cohort and 22.4% (95% CI: -8.7; 44.8) in the 12-18 month cohort.
Danish: For catch-up-vaccination var vaccineeffektiviteten 33,2 % (95 % CI: 3,0; 53,4) i 7-11 månederskohorten og 22,4 % (95 % CI: -8,7; 44,8) i 12-18 måneders-kohorten.
English: Immunogenicity data
Danish: Immunogenicitetsdata
English: Before and after NIP comparison suggests a significant decrease in the incidence of any culture confirmed IPD, any vaccine serotype IPD and IPD due to serotype 19A.
Danish: En sammenligning før og efter NIP viser et signifikant fald i hyppigheden af alle tilfælde af IPD bekræftet ved dyrkning, alle IPDvaccineserotyper, og IPD, som skyldes serotype 19A.
English: After the primary vaccination course, fever ≥38 °C and >39 °C was reported respectively in 86.1% and 14.7% of children receiving Synflorix and in 82.9% and 11.6% of children vaccinated with 7-valent Prevenar.
Danish: Efter det primære vaccinationsprogram blev feber på ≥ 38,5 °C og > 39 °C observeret hos hhv. 86,1 % og 14,7 % af de børn, som fik Synflorix og hos hhv. 82,9 % og 11.6 % af de børn, som fik 7-valent Prevenar.
English: Preterm infants (born after 27 weeks and less than 37 weeks of pregnancy): Your child (from 2 months to 6 months of age) will receive 3 injections with an interval of at least one month between each dose.
Danish: For tidligt fødte spædbørn (født mellem 27. og 37. svangerskabsuge): Dit barn (i alderen fra 2-6 måneder) skal have 3 indsprøjtninger med mindst en måned mellem hver indsprøjtning.
English: Vaccine efficacy (95% CI)
Danish: Vaccineeffekt (95 % CI)