FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Numbers and percentages of subjects with first episodes of B-CAP occurring from 2 weeks after the administration of the 3rd dose of Synflorix or control vaccine and vaccine efficacy (ATP cohort)
Danish: Tabel 2: Antal og procentdel af personer med første tilfælde af B-CAP, opstået fra 2 uger efter tredje dosis Synflorix eller kontrolvaccine, samt vaccinens effekt (ATP-kohorte) Synflorix N=10.295
English: The third clinical study showed that the administration of 2 doses with a 2 month interval starting at 36-46 months of age resulted in higher ELISA antibody GMCs and OPA GMTs than those observed one month after a 3-dose primary vaccination for each vaccine serotype and the cross-reactive serotype 19A.
Danish: Det tredje kliniske studie viste, at administration af to doser med 2 måneders interval, startende ved 36-46-måneders-alderen, resulterede i højere ELISA-antistof-GMC og OPA-GMT, end der blev set en måned efter et 3-dosis program for hver enkelt vaccineserotype og den krydsreaktive serotype 19A.
English: The clinical relevance of the above observations is unknown.
Danish: Den kliniske relevans af ovenstående observationer kendes ikke.
English: Children with sickle cell disease
Danish: Børn med seglcellesygdom
English: The booster dose of Synflorix in HIV+/+ and HIV+/- infants induced robust increases in ELISA antibody GMCs and OPA GMTs for each vaccine serotype and serotype 19A indicative of immunological priming.
Danish: Boosterdosis med Synflorix hos hiv +/+ og hiv +/- spædbørn inducerede en robust stigning i ELISA antistof GMCs og OPA GMTs, for hver af vaccinens serotyper og serotype 19A, hvilket indikerer immunologisk priming.
English: In the catch-up cohorts, children between 7-11 months of age at first vaccine dose received Synflorix or hepatitis B control vaccine according to a 2-dose primary schedule followed by a booster dose and children between 12-18 months of age at first vaccine dose received 2 doses of either Synflorix or hepatitis A control vaccine.
Danish: I catch-up-kohorten fik børn i alderen 7-11 måneder ved første vaccinedosis enten Synflorix eller hepatitis B-kontrolvaccine i henhold til et primært 2-dosisprogram efterfulgt af en boosterdosis, og børn i alderen 12-18 måneder ved første vaccinedosis fik enten 2 doser Synflorix eller 2 doser hepatitis A-kontrolvaccine.
English: If your child misses an injection
Danish: Hvis du har glemt dit barns vaccination
English: In subjects that had received a 3-dose primary series followed by a booster dose, at least 96.5% of the subjects remained seropositive for vaccine serotypes and 86.4% for serotype 19A.
Danish: Mindst 96,5 % af de børn, som fik et primært program med 3 doser efterfulgt af en boosterdosis, forblev seropositive over for vaccineserotyperne, og 86,4 % forblev seropositive over for serotype 19A.
English: Safety and immunogenicity data are available for HIV infected infants (asymptomatic or with mild symptoms according to WHO classification), HIV negative infants born from HIV positive mothers, children with sickle cell disease and children with splenic dysfunction (see sections 4.8 and 5.1).
Danish: Sikkerheds- og immunogenicitetsdata er tilgængelige for hiv smittede spædbørn (asymptomatisk eller med lette symptomer i henhold til WHO klassifikation), hiv-negative spædbørn født af hiv-positive mødre, børn med seglcellesygdom og børn med dysfunktion af milten (se pkt.
English: Fever ≥ 38 °C rectally (age 2 to 5 years) Uncommon Fever > 40 °C rectally (age < 2 years), fever > 39 °C rectally (age 2 to 5 years), injection site reactions like diffuse swelling of the injected limb, sometimes involving the adjacent joint, pruritus.
Danish: Feber > 40 °C rektalt (hos børn < 2 år), feber > 39 °C rektalt (hos børn 2-5 år), reaktioner på administrationsstedet, f.eks. diffus hævelse af den injicerede legemsdel, nogle gange involverende det tilstødende led, pruritus
English: If you are not sure, talk to your doctor or pharmacist before your child is given Synflorix.
Danish: Hvis du er i tvivl, skal du tale med lægen eller apotekspersonalet, inden dit barn får Synflorix.
English: The protection against B-CAP before booster dose and at the time or after booster dose was 13.6% (95% CI: -11.3; 33.0) and 21.7% (95% CI: 3.4; 36.5) respectively.
Danish: Beskyttelsen mod B-CAP før boosterdosis og ved eller efter boosterdosis var henholdsvis 13,6 % (95 % CI -11,3; 33,0) og 21,7 % (95 % CI 3,4; 36,5).
English: In a large-scale phase III/IV, double-blind, cluster-randomized, controlled, clinical trial in Finland (FinIP), children were randomised into 4 groups according to the two infant vaccination schedules [2-dose (3, 5 months of age) or 3-dose (3, 4, 5 months of age) primary schedule followed by a booster dose as of 11 months of age] to receive either Synflorix (2/3rd of clusters) or hepatitis vaccines as control (1/3rd of clusters).
Danish: I et stort fase III/IV, dobbeltblindet, center-randomiseret, kontroleret klinisk studie i Finland (FinIP), blev børn randomiseret i 4 grupper i henhold til de to primære børnevaccinationsprogrammer [2-dosis (3-, 5-månedersalderen) eller 3-dosis (3-, 4-, 5-månedersalderen) efterfulgt af en boosterdosis ved 11månedersalderen] og tildelt enten Synflorix (2/3 af studiecentrene) eller hepatitisvaccine som kontrol (1/3 af studiecentrene).
English: Serotype specific efficacy against the first AOM episode was demonstrated for serotypes 6B (86.5%, 95% CI: 54.9; 96.0), 14 (94.8%, 95% CI: 61.0; 99.3), 19F (43.3%, 95% CI: 6.3; 65.4) and 23F (70.8%, 95% CI: 20.8; 89.2).
Danish: Serotypespecifik effekt mod det første tilfælde af AOM blev påvist for serotype 6B (86,5 %, 95 % CI 54,9;96,0), 14 (94,8 %, 95 % CI 61,0;99,3), 19F (43,3 %, 95 % CI 6,3;65,4) og 23F (70,8 %, 95 % CI 20,8;89,2).
English: In the FinIP study, vaccine effectiveness in reducing hospital-diagnosed pneumonia cases (identified based on the ICD 10 codes for pneumonia) was 26.7% (95% CI: 4.9; 43.5) in the 3+1 infant schedule and 29.3% (95% CI: 7.5; 46.3) in the 2+1 infant schedule.
Danish: I FinIP-studiet var vaccineeffektiviteten mht. reducering af hospitalsdiagnosticerede tilfælde af pneumoni (identificeret på basis af ICD 10-koden for pneumoni) 26,7 % (95 % CI: 4,9; 43,5) i 3+1 børnevaccinationsprogrammet og 29,3 % (95 % CI: 7,5; 46,3) i 2+1 børnevaccinationsprogrammet.
English: Reactogenicity was higher in children receiving whole cell pertussis vaccines concomitantly.
Danish: Reaktogenicitet var højere hos børn, der fik helcelle-pertussis-vacciner samtidig med Synflorix.
English: In individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as Human Immunodeficiency Virus (HIV) infection, sickle cell disease (SCD) or splenic dysfunction), Synflorix may be given according to the above mentioned schedules except that a 3-dose schedule should be given as primary vaccination in infants starting vaccination from 6 weeks to 6 months of age (see sections 4.4 and 5.1).
Danish: Synflorix kan gives til personer, der har en underliggende sygdom, der prædisponerer dem for invasiv pneumokoksygdom (såsom humant immundefektvirus (hiv)-infektion, seglcellesygdom (SCD) eller dysfunktion af milten), og kan gives i henhold til de ovenfor nævnte vaccinationsprogrammer, bortset fra at vaccinationsprogrammet med 3 doser skal gives som primær vaccination hos spædbørn, der starter vaccinationen fra de er 6 uger til 6 måneder (se pkt.
English: 3-6 micrograms
Danish: 3-6 mikrogram
English: Post-primary and post-booster OPA antibody geometric mean titres (GMTs) elicited by Synflorix were lower than those elicited by 7-valent Prevenar for the seven shared serotypes, except for serotype 19F.
Danish: De postprimære og post-booster geometrisk gennemsnitlige OPA-antistof-titerværdier (antistof-GMT), som Synflorix fremkaldte, var lavere end dem, som 7-valent Prevenar fremkaldte, for de 7 fælles serotyper, med undtagelse af serotype 19F.
English: (2) Culture confirmed cases for serotypes 1, 4, 6B, 7F, 9V, 14, 18C, 19F and 23F contributed to the analysis.
Danish: (2) Dyrkningsbekræftede tilfælde for serotype 1, 4, 6B, 7F, 9V, 14, 18C, 19F og 23F bidrog til analysen.
English: • Kawasaki disease (major signs of the illness are for instance: fever, skin rash, swollen lymph glands, inflammation and rash of the mucous membranes of the mouth and throat)
Danish: • Kawasakis syndrom (de hyppigste tegn er f.eks. feber, hududslæt, hævede lymfeknuder og en betændelseslignende reaktion eller udslæt i mund- og halsslimhinder).
English: What you need to know before your child receives Synflorix
Danish: Det skal du vide, før dit barn får Synflorix
English: The reduction in B-CAP and C-CAP was greatest in children < 36 months of age (vaccine efficacy of 20.6% (95% CI: 6.5; 32.6) and 24.2% (95% CI: 7.4; 38.0) respectively).
Danish: Reduktionen i B-CAP og C-CAP var størst hos børn < 36 måneder (vaccineeffekten var henholdsvis 20,6 % (95 % CI 6,5; 32,6) og 24,2 % (95 % CI 7,4; 38,0).
English: (3) Culture or PCR confirmed cases for serotypes 4, 6B, 7F, 9V, 14, 18C, 19F and 23F contributed to the analysis.
Danish: (3) Dyrknings- eller PCR-bekræftede tilfælde for serotyperne 4, 6B, 7F, 9V, 14, 18C, 19F og 23F bidrog til analysen.
English: If not used within 6 hours it should be discarded.
Danish: Vaccinen skal kasseres, hvis den ikke er brugt inden for 6 timer.
English: The clinical relevance of this lower post-primary OPA response is not known.
Danish: Den kliniske relevans af dette lavere OPA repons efter den primære vaccination er ikke kendt.
English: Clinical trials Immune system disorders
Danish: Kliniske studier Immunsystemet
English: The mean duration follow-up from 2 weeks post-dose 3 in the ATP cohort was 23 months (range from 0 to 34 months) for the interim analysis (IA) and 30 months (range from 0 to 44 months) for the end-of-study analysis.
Danish: Den gennemsnitlige opfølgningsperiode i kohorten anført i protokollen (ATP-kohorte; According to Protocol) fra 2 uger efter tredje dosis var 23 måneder (interval 0-34 måneder) i interimanalysen og 30 måneder (interval 0-44 måneder) i den endelige studieanalyse.
English: Synflorix can be given at the same time as other childhood vaccines such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B, measles-mumps-rubella, varicella, oral rotavirus vaccines as well as meningococcal serogroup C and serogroups A, C, W-135, Y conjugate vaccines.
Danish: Synflorix kan gives samtidigt med andre børnevacciner, f.eks. difteri-, stivkrampe-, kighoste-, Haemophilus influenzae type b-, polio-, hepatitis B-, mæslinge-fåresyge-røde hunde- (MFR), skoldkoppe- og rotavirus-vaccine samt konjugerede meningokok-serogruppe C-vacciner og konjugerede meningokok-serogruppe A, C, W-135, Y-vacciner.
English: Each 0.5 ml dose contains 1 microgram of polysaccharide for serotypes 1, 5, 6B, 7F, 9V, 14 and 23F, and 3 micrograms for serotypes 4, 18C and 19F
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dosis (0,5 ml) indeholder 1 mikrogram polysaccharid af serotyperne 1, 5, 6B, 7F, 9V, 14 og 23F, samt 3 mikrogram af serotyperne 4, 18C og 19F
English: To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock.
Danish: Kanylen sættes på injektionssprøjten ved at skrue kanylen med uret, indtil man har en fornemelse af, at den låser.
English: Do not administer intravascularly.
Danish: Den må ikke indgives intravaskulært.
English: • Synflorix is available in pre-filled syringes for 1 dose with or without needles in packs of 1, 10 or 50.
Danish: • Synflorix fås i fyldte injektionssprøjter til 1 dosis med eller uden kanyler i pakninger på 1, 10 eller 50.
English: The administration of a fourth dose (booster dose) in the second year of life elicited an anamnestic antibody response as measured by ELISA and OPA for the vaccine serotypes and the cross-reactive serotype 19A demonstrating the induction of immune memory after the three-dose primary course.
Danish: Administrationen af en fjerde dosis (boosterdosis) i andet leveår fremkaldte et anamnestisk antistofrespons målt vha. ELISA og OPA for vaccineserotyperne og den krydsreaktive serotype 19A, hvilket viser induktion af immunologisk hukommelse efter det primære vaccinationsprogram med 3 doser.
English: schedule schedule
Danish: program program
English: For adsorbent, see section 2.
Danish: Vedrørende adsorberende stof, se pkt.
English: 10 pneumococcal vaccine serotypes
Danish: 10 pneumokokvaccineserotyper
English: - infants aged 7-11 months: The vaccination schedule consists of two primary doses of 0.5 ml with an interval of at least 1 month between doses.
Danish: - spædbørn i alderen 7-11 måneder: Vaccinationsprogrammet består af to primære doser på hver 0,5 ml givet med et interval på mindst 1 måned mellem doserne.
English: Pack size of 100.
Danish: Pakningsstørrelse på 100.
English: Efficacy of the 11 Pn-PD vaccine against the first occurrence of vaccine serotype AOM episode was 52.6% (95% CI: 35.0; 65.5).
Danish: Effekten af 11 Pn-PD-vaccinen mod det første tilfælde af vaccineserotype-AOM var 52,6 % (95 % CI 35,0;65,5).
English: Other medicines and Synflorix
Danish: Brug af anden medicin sammen med Synflorix
English: In Finland, Synflorix was introduced into NIP with a 2+1 schedule in infants (3, 5 months of age and a booster dose at 12 months) without catch-up campaign.
Danish: Synflorix blev indført i NIP i Finland hos spædbørn med 2+1 programmet (3, 5 måneder og en boosterdosis ved 12 måneder) uden opfølgningskampagne.
English: In the second clinical study, a single dose administered four months after two catch-up doses at 12-20 months of age elicited a marked increase of ELISA GMCs and OPA GMTs (when comparing the responses pre and post the last dose), indicating that two catch-up doses provide adequate priming.
Danish: I det andet kliniske studie fremkaldte en enkelt dosis, administreret fire måneder efter to catch-updoser (givet i alderen 12-20 måneder), en markant stigning i ELISA-GMC og OPA-GMT (ved sammenligning af responset før og efter den sidste dosis).
English: For serotypes 6B and 23F, respectively, 65.9% and 81.4% of infants vaccinated at 2, 3 and 4 months reached the antibody threshold (i.e. 0.20 µg/ml) one month after the third dose of Synflorix versus 79.0% and 94.1% respectively, after three doses of 7-valent Prevenar.
Danish: For serotyperne 6B og 23F opnåede hhv. 65,9 % og 81,4 % af de spædbørn, som blev vaccineret, da de var 2, 3 og 4 måneder, tærskelværdien for antistoffer (f.eks. 0,20 μg/ml) en måned efter den tredje primærdosis med Synflorix, hvorimod henholdsvis 79,0 % og 94,1 % opnåede tærskelværdien efter 3 doser 7-valent Prevenar.
English: Efficacy of Synflorix against first episodes of likely bacterial Community Acquired Pneumonia (CAP) occurring from 2 weeks after the administration of the 3rd dose was demonstrated in the ATP cohort
Danish: Synflorix' virkning mod første tilfælde af sandsynlig bakteriel samfundserhvervet pneumoni (CAPCommunity Acquired Pneumonia), opstået fra 2 uger efter administration af tredje dosis, blev påvist i ATP-kohorten (p ≤ 0,002) i interimanalysen (event-driven; primært endemål).
English: 4-dose container Sodium chloride 2-phenoxyethanol Water for injections
Danish: 4-dosis beholder Natriumchlorid 2-phenoxyethanol Vand til injektionsvæsker
English: In Brazil, Synflorix was introduced into the national immunisation programme (NIP) using a 3+1 schedule in infants (2, 4, 6 months of age and a booster dose at 12 months) with a catch-up campaign in children up to 2 years of age.
Danish: Synflorix blev indført i det nationale immuniseringsprogram (NIP) i Brasilien med 3+1 programmet hos spædbørn (2, 4, 6 måneder og en boosterdosis ved 12 måneder) med en opfølgningskampagne hos børn op til 2 år.
English: The percentage of subjects with OPA titres ≥ 8 in 2-dose primed subjects compared to 3-dose primed subjects were lower for serotypes 6B, 18C and 23F (74.4%, 82.8%, 86.3% respectively for the 2-dose schedule and 88.9%, 96.2%, 97.7% respectively for the 3-dose schedule).
Danish: Der blev fundet en lavere procentdel af børn med OPA-titer ≥ 8 i 2-dosis-gruppen i forhold til 3-dosis-gruppen for serotyperne 6B, 18C og 23F (henholdsvis 74,4 %, 82,8 %, 86,3 % for 2-dosisprogrammet og 88,9 %, 96,2 %, 97,7 % for 3-dosisprogrammet).
English: 1-dose and 2-dose containers Sodium chloride Water for injections
Danish: 1-dosis og 2-dosis beholder Natriumchlorid Vand til injektionsvæsker
English: Vaccine effectiveness was 6.1% (95% CI: -2.7; 14.1) for the 3+1 schedule and 7.4% (95% CI -2.8; 16.6) for 2+1 schedule for this AOM endpoint in the infant vaccinated cohort.
Danish: Vaccineeffektiviteten for dette AOM-endepunkt var 6,1 % (95 % CI -2,7; 14,1) for 3+1-programmet og 7,4 % (95 % CI -2,8; 16,6) for 2+1-programmet i den vaccinerede spædbørnskohorte.
English: Efficacy against any NTHi AOM episode was 35.3% (95% CI: 1.8; 57.4).
Danish: Effekten mod alle NTHi-AOM-tilfælde var 35,3 % (95 % CI 1,8; 57,4).
English: One month after the booster dose increases of ELISA antibody GMCs and OPA GMTs were seen for each vaccine serotype and the cross-reactive serotype 19A, indicative of immunological memory.
Danish: En måned efter boosterdosis blev forhøjede ELISA-antistof-GMC og OPA-GMT set for hver vaccineserotype samt for den krydsreaktive serotype 19A, hvilket indikerer immunologisk hukommelse.
English: • collapse (sudden onset of muscle floppiness), periods of unconsciousness or lack of awareness,
Danish: • pludselig muskelslaphed, perioder med bevidstløshed eller nedsat bevidsthed og bleghed eller blåfarvning af huden.
English: Immune memory
Danish: Immunologisk hukommelse
English: - for children with seizure disorders or with a prior history of febrile seizures.
Danish: - til alle børn med krampetilfælde eller med feberkramper i anamnesen.
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in multidose container (4 doses) 10 MULTIDOSE vials (4 doses per vial - 0.5 ml per dose) 100 MULTIDOSE vials (4 doses per vial - 0.5 ml per dose)
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, suspension i flerdosisbeholder (4 doser) 10 hætteglas, FLERDOSISBEHOLDER (4 doser pr. hætteglas - 0,5 ml pr. dosis) 100 hætteglas, FLERDOSISBEHOLDER (4 doser pr. hætteglas - 0,5 ml pr. dosis)
English: Uncommon Nausea (age 2 to 5 years)
Danish: Kvalme (hos børn 2-5 år)
English: The vaccine efficacy against the first episode of NTHi AOM was 31.1% (95% CI: -3.7; 54.2, not significant).
Danish: Vaccineeffekten mod det første tilfælde af NTHi-AOM var 31,1 % (95 % CI -3,7; 54,2; ikke signifikant).
English: In the study conducted in South Africa, the booster dose given at 9-10 months of age induced marked increases in antibody GMCs and OPA GMTs for each vaccine serotype and serotype 19A in both 2dose and 3-dose priming groups indicative of immunological priming.
Danish: I studiet der blev udført i Sydafrika inducerede en boosterdosis, givet ved 9-10 måneders alderen, markante stigninger i antistof GMCs og OPA GMTs for hver af vaccinens serotyper og serotype 19A, ved både gruppen med 2-dosis og 3-dosis-primærvaccinationsprogrammerne, hvilket indikerer immunologisk priming.
English: What Synflorix is and what it is used for What you need to know before your child receives Synflorix How Synflorix is given
Danish: Virkning og anvendelse Det skal du vide, før dit barn får Synflorix Sådan gives Synflorix
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL, PACK OF 1, 10, 100
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE HÆTTEGLAS, PAKNINGER MED 1, 10, 100
English: Among children with SCD, 48 children <6 months of age received primary vaccination at 8, 12 and 16 weeks of age, followed by a booster dose at 9-10 months of age, 50 children aged 7-11 months and 48 aged 12-23 months started catch-up vaccination according to their age.
Danish: Blandt de børn med SCD, modtog 48 børn i alderen < 6 måneder primær vaccination ved 8, 12 og 16 ugers alderen, efterfulgt af en boosterdosis ved 9-10 måneders alderen, 50 børn i alderen 7-11 måneder og 48 børn i alderen 12-23 måneder startede catch-up vaccination i henhold til deres alder. Synflorix's immunrespons for hver af vaccines serotyper og serotype 19A, såvel for protein D, så ikke ud til at være påvirket af SCD.
English: PHARMACEUTICAL FORM Suspension for injection (injection).
Danish: LÆGEMIDDELFORM Injektionsvæske, suspension.
English: After primary vaccination, for the vaccine serotypes the percentages of subjects reaching antibody threshold and with OPA titres ≥ 8 were similar after 2-dose compared to 3-dose except lower OPA percentage for serotype 14.
Danish: For vaccinens serotyper var procentdelen af personer der opnåede tærskelværdier for antistoffer og med OPA titer ≥ 8, efter primær vaccination, ens efter 2dosisprogrammet sammenlignet med 3-dosisprogrammet, bortset fra en lavere OPA procentdel for serotype 14.
English: In preterm infants born after at least 27 weeks of gestational age, the recommended immunisation series consists of four doses, each of 0.5 ml.
Danish: Det anbefalede immuniseringsprogram for præmature spædbørn, født efter 27. svangerskabsuge, består af 4 doser, hver på 0,5 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF PRE-FILLED SYRINGE WITH OR WITHOUT NEEDLE, PACK OF 1, 10, 50
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL FYLDT INJEKTIONSSPRØJTE MED ELLER UDEN KANYLE, PAKNINGER MED 1, 10 OG 50
English: One 0.5 ml dose contains:
Danish: 1 dosis (0,5 ml) indeholder:
English: The vaccine should be well shaken before use.
Danish: Vaccinen skal omrystes godt før administration.
English: However, the clinical relevance of this observation is not known.
Danish: Den kliniske relevans af denne observation er imidlertid ikke kendt.
English: Efficacy against any AOM episode due to any pneumococcal serotype was 51.5% (95% CI: 36.8; 62.9).
Danish: Effekten mod alle AOM-tilfælde for alle pneumokokserotyper var 51,5 % (95 % CI 36,8;62,9).
English: In another large randomised double-blind trial (POET) conducted in the Czech Republic and in Slovakia, 4,907 infants (ATP cohort) received either the 11-valent investigational vaccine (11Pn-PD) containing the 10 serotypes of Synflorix (along with serotype 3 for which efficacy was not demonstrated) or a control vaccine (hepatitis A vaccine) according to a 3, 4, 5 and 12-15 months vaccination schedule.
Danish: Her fik 4.907 spædbørn (ATP-kohorte) enten en 11-valent testvaccine (11Pn-PD), der indeholdt de 10 serotyper i Synflorix (samt yderligere serotype 3, som der ikke blev påvist effekt af) eller en kontrolvaccine (hepatitis A-vaccine) i overenstemmelse med et vaccinationsprogram, hvor børnene blev vaccineret, da de var 3, 4, 5 måneder og 12-15 måneder.
English: A fine white deposit with a clear colourless supernatant may be observed upon storage of the pre-filled syringe.
Danish: Der kan forekomme et fint, hvidt bundfald med en klar, farveløs supernatant ved opbevaring af den fyldte injektionssprøjte.
English: Higher OPA GMTs in the group boosted at 15-18 months of age were observed for most of the vaccine serotypes and serotype 19A.
Danish: Der blev observeret højere OPA GMTs for de fleste af vaccinens serotyper og serotype 19A, hos den gruppe der fik en boosterdosis ved 15-18 måneders alderen.
English: Immunogenicity of Synflorix in very preterm (gestation period of 27-30 weeks) (N=42), preterm (gestation period of 31-36 weeks) (N=82) and full term (gestation period > 36 weeks) (N=132) infants was evaluated following a 3-dose primary vaccination course at 2, 4, 6 months of age.
Danish: Immunogeniciteten af Synflorix hos meget præmature spædbørn (født i 27.-30. svangerskabsuge) (N = 42), hos præmature spædbørn (født i 31.-36. svangerskabsuge) (N = 82) og spædbørn født ved terminen (født efter 36. svangerskabsuge) (N = 132) blev vurderet efter et primært vaccinationsprogram med 3 doser ved 2, 4, 6 måneders alderen.
English: 0.5 milligram Al3+ in total 2 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
Danish: Total: 0,5 milligram Al 2 konjugeret til protein D (fra ikke-kapselbærende Haemophilus influenzae)-bærerprotein