FrancophonIA/ELRC3.0 huggingface dataset:
English: Menveo may be given at the same time as other vaccinations but any other injected vaccines should preferably be given into a different arm from the site of the Menveo injection.
Danish: Menveo kan gives sammen med andre vacciner, men indsprøjtning af eventuelle andre vacciner skal fortrinsvist gives i den modsatte arm i forhold til den, den bliver brugt til Menveo.
English: 5.6 to 10.0 micrograms
Danish: 5,6 til 10,0 mikrogram
English: Very common: sleepiness, headache
Danish: Meget almindelige: søvnighed, hovedpine
English: Very common: myalgia
Danish: Meget almindelige: myalgi
English: After reconstitution, the product should be used immediately.
Danish: Efter rekonstitution skal præparatet anvendes straks.
English: This vaccine can only protect against meningococcal group A, C, W-135, and Y bacteria.
Danish: Denne vaccine beskytter kun mod meningokokgruppe A, C, W-135, og Y bakterier.
English: (≥1/10,000 to <1/1,000)
Danish: (≥1/10.000 til < 1/1.000)
English: The two primary safety studies were randomised, active-controlled trials that enrolled participants aged 11 to 55 years (N=2663) and 19 to 55 years (N=1606), respectively.
Danish: De to primære sikkerhedsstudier var randomiserede, aktivt kontrollerede studier med deltagere i alderen henholdsvis 11 til 55 år (N=2.663) og 19 til 55 år (N=1.606).
English: hSBA GMTs
Danish: hSBA GMT
English: Marketing Authorisation Holder: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Danish: Indehaver af markedsføringstilladelsen: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italien
English: 5 year persistence 1 month after booster
Danish: 1 måned efter booster Persistens efter 5 år
English: There are limited data in individuals aged 56-65 and there are no data in subjects aged older than 65 years.
Danish: Der er begrænset erfaring med vaccinen hos personer i alderen 56-65 år, og der er ingen data for personer over 65 år.
English: Your doctor or nurse may still recommend that you receive Menveo if you are at high risk of infection with meningococcal group A, C, W-135 and Y bacteria.
Danish: Din læge eller sygeplejerske kan stadig anbefale, at du får Menveo, hvis du har stor risiko for infektion med meningokokgruppe A-, C-, W135- og Y-bakterier.
English: The reactogenicity profile and rates of adverse events among subjects aged 56-65 years who received Menveo (N=216), were similar to that observed in Menveo recipient subjects aged 11-55.
Danish: Reaktogenicitetsprofilen og forekomsten af bivirkninger blandt forsøgspersoner i alderen 56-65 år der fik Menveo (N=216), var i overensstemmende med de observerede for Menveo forsøgspersoner i alderen 11-55.
English: Your doctor will advise you if and when you should receive a booster dose.
Danish: Din læge vil fortælle dig det, hvis du skal have en boosterdosis.
English: In adolescents (11 to 18 years of age), Menveo has been evaluated in two co-administration studies with either Tetanus, Reduced Diphtheria and Acellular Pertussis Vaccine, Adsorbed (Tdap) alone or Tdap and Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (HPV), both of which support the co-administration of the vaccines.
Danish: Menveo er blevet evalueret i to interaktionsstudier hos unge (i alderen 11-18 år) sammen med enten Tdap (adsorberet tetanus, difteri og acellulær pertussis) alene eller Tdap og rekombinant kvadrivalent HPV-vaccine (human papillomavirus type 6, 11, 16 og 18); begge studier understøtter samtidig administration af vaccinerne.
English: Studies with Menveo have shown a waning of serum bactericidal antibody titers against serogroup A when using human complement in the assay (hSBA) (see section 5.1).
Danish: Studier med Menveo har vist et fald i serum-baktericide antistoftitre mod serogruppe A, når der anvendes humant komplement i analysen (hSBA) (se pkt.
English: Even if you have been vaccinated with Menveo you remain at increased risk of disease caused by the Neisseria meningitidis groups A, C, W-135 and Y bacteria.
Danish: Selvom du er blevet vaccineret med Menveo, er du stadig i øget risiko for sygdom forårsagt af Neisseria meningitidis grupperne A, C, W-135 og Y bakterier.
English: Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group A, C, W-135 and Y, even if they develop antibodies following vaccination with Menveo.
Danish: Personer med familiær komplementdefekt (f.eks. C3 eller C5 defekt) og personer, der modtager behandling, som inhiberer den terminale komplement aktivering (f.eks. eculizumab), er i øget risiko for invasiv sygdom forårsaget af Neisseria meningitidis grupperne A, C, W-135 og Y, også hvis de udvikler antistoffer efter vaccination med Menveo.
English: Although a high percentage of subjects achieved hSBA titres above 1:8 following 4-dose series of Menveo, with lower percentages in studies of 2-dose series and of a single dose, Menveo was compared to another meningococcal vaccine in only one pivotal study, where it failed to show a response at least equivalent to a monovalent conjugated serotype C vaccine (after a single dose at the age of 12 months).
Danish: Selvom en høj procentdel af forsøgspersonerne opnåede hSBA-titre på over 1:8 efter en serie på 4 doser Menveo, med lavere procentdele i studier med serier med 2 doser og med en enkelt dosis, er Menveo kun blevet sammenlignet med en anden meningokokvaccine i et enkelt pivotalt studie, hvor det ikke viste et respons, der som minimum var lig med en monovalent konjugeret serotype C-vaccine
English: Excipients: Potassium dihydrogen phosphate, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, water for injection.
Danish: Hjælpestoffer: Kaliumdihydrogenphosphat, saccharose, natriumchlorid, natriumdihydrogenphosphatmonohydrat, dinatriumphosphatdihydrat, vand til injektionsvæsker.
English: Therefore, Menveo may be used during breast feeding.
Danish: Menveo kan derfor anvendes under amning.
English: (≥1/100 to <1/10)
Danish: (≥1/100 til < 1/10)
English: Serog roup
Danish: Serog ruppe
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italien
English: The clinical relevance of the waning of hSBA serogroup A antibody titers is unknown.
Danish: Den kliniske relevans af faldet af antistoftitre i hSBA-serogruppe A kendes ikke.
English: The contents in the two different vials (MenA powder and MenCWY solution) are to be mixed prior to vaccination providing 1 dose of 0.5 ml.
Danish: Indholdet i de to hætteglas (MenA-pulver og MenCWY-opløsning) skal blandes før vaccination, så der opnås 1 dosis på 0,5 ml.
English: Menveo contains
Danish: Menveo indeholder
English: All subjects in both age groups had hSBA ≥ 1:8 across all serogroups, with antibody titers several fold higher than seen after the primary vaccination (Table 3).
Danish: Alle forsøgsdeltagere i begge aldersgruppe havde hSBA ≥ 1:8 på tværs af alle serogrupper med antistoftitre, som var flere gange højere end dem, der blev observeret efter den primære vaccination (tabel 3).
English: In two supportive studies V59P8 and V59P10 immunogenicity of Menveo was compared to ACWY-PS.
Danish: I to understøttende studier, V59P8 og V59P10, blev Menveos immunogenicitet sammenlignet med ACWY-PS.
English: In the powder: potassium dihydrogen phosphate and sucrose.
Danish: I pulveret: kaliumdihydrogenphosphat og saccharose.
English: (Originally contained in the solution) • Meningococcal group C oligosaccharide
Danish: (Oprindeligt indeholdt i opløsningen) • Meningokokoligosaccharid-gruppe C
English: A total of 199 subjects 2-5 years of age were in the Menveo per protocol immunogenicity population and 81 subjects 3-5 years of age were in the ACWY-PS group.
Danish: I den per protokol-immunogenicitetspopulation, der fik Menveo, var der i alt 199 forsøgspersoner i alderen 2-5 år, og i ACWY-PS-gruppen var der 81 forsøgspersoner i alderen 3-5 år.
English: In a randomized, observer-blind study (V59_57) conducted in US, immunogenicity of a 2-dose series and a single dose of Menveo was compared in children 2 through 5 and 6 through 10 years of age (N=715).
Danish: I et randomiseret, observatørblindet studie (V59_57), der blev gennemført i USA, blev immunogeniciteten af en serie med 2 doser Menveo og en enkelt dosis Menveo sammenlignet hos børn i alderen 2-5 år og 6-10 år (N = 715).
English: To ensure optimal antibody levels against all vaccine serogroups, the primary vaccination schedule with Menveo should be completed one month prior to risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y. Bactericidal antibodies (hSBA≥1:8) were observed in at least 64% of subjects at 1 week post vaccination (see section 5.1 for immunogenicity data per individual serogroups).
Danish: For at sikre optimale antistofniveauer mod alle vaccine-serogrupper bør det primære vaccinationsprogram med Menveo være afsluttet en måned inden risiko for udsættelse for Neisseria meningitidis gruppe A, C, W-135 og Y. Der blev observeret baktericide antistoffer (hSBA≥1:8) hos mindst 64% af de vaccinerede 1 uge efter vaccination (se pkt.
English: Metabolism and nutrition disorders:
Danish: Det drejede sig om følgende bivirkninger: Metabolisme og ernæring:
English: No effects on fertility were observed in female rabbits receiving Menveo pre-mating and during pregnancy.
Danish: Der blev ikke observeret virkninger på fertiliteten hos hunkaniner, der fik Menveo inden parring og under drægtighed.
English: The onset of immune response after the primary vaccination with Menveo in healthy subjects 18 through 22 years of age was evaluated in study V59P6E1.
Danish: Indtræden af immunrespons efter primær vaccination med Menveo hos raske forsøgspersoner i alderen 18-22 år blev vurderet i studie V59P6E1.
English: One dose consists of 1 vial of MenA Lyophilised Conjugate Component to be reconstituted with 1 vial of MenCWY Liquid Conjugate Component.
Danish: En dosis består af 1 hætteglas med MenA frysetørret konjugeret komponent til rekonstitution med 1 hætteglas med MenCWY flydende konjugeret komponent.
English: The contents of the two components (vial and vial) are to be mixed prior to vaccination providing 1 dose of 0.5 ml.
Danish: Indholdet af de to komponenter (hætteglas og hætteglas) blandes inden vaccination og giver 1 dosis på 0,5 ml.
English: These include the following vaccines: tetanus, reduced diphtheria and acellular pertussis (Tdap), human papillomavirus (HPV), yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies, hepatitis A and B and meningococcal group B (Bexsero).
Danish: Andre vacciner omfatter følgende: vaccine mod stivkrampe, difteri og kighoste (Tdap), vaccine mod humant papillomavirus (HPV), gul feber, tyfus (Vi polysaccharid), japansk encefalitis, rabies, hepatitis A og B, og meningokokgruppe B (Bexsero).
English: Table 8: Response to Booster: bactericidal antibody responses to Menveo booster administered at 3 or 5 years after the primary vaccination with Menveo or ACWY-PS in subjects aged 11-17 years
Danish: Tabel 8: Respons på booster: Baktericidt antistofsrespons på Menveo-booster administreret 3 eller 5 år efter primær vaccination med Menveo eller ACWY-PS hos forsøgspersoner i alderen 11-17 år
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo powder for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Menveo pulver til injektion
English: (≥1/1,000 to <1/100)
Danish: (≥1/1.000 til < 1/100)
English: Individuals with complement deficiencies and individuals with functional or anatomical asplenia may not mount an immune response to meningococcal group A, C, W-135 and Y conjugate vaccines.
Danish: Individer med komplementmangel eller funktionel og/eller anatomisk aspleni kan muligvis ikke etablere et immunrespons på meningokokgruppe A, C, W-135 og Y konjugerede vacciner.
English: In the children 2-10 years of age, as well as in each age strata (2-5 and 6-10 years), immune response as measured by percentage of subjects with seroresponse, hSBA≥1:8 and GMTs were not only non-inferior to comparator vaccine ACWY-PS, but all were statistically higher than the comparator for all serogroups and all immune measurements at 1 month post vaccination.
Danish: I gruppen af børn i alderen 2-10 år såvel som i hvert enkelt stratum (2-5 år og 6-10 år) var immunresponset, målt som procentdelen af forsøgspersoner med serorespons, hSBA ≥ 1:8 og GMT'ere, ikke kun non-inferiørt i forhold til komparator-vaccinen ACWY-PS, men alle målinger var statistisk højere end komparatoren i alle serogrupper og alle immunmålinger én måned efter vaccinationen.
English: Very common: headache
Danish: Meget almindelige: hovedpine
English: In the non-inferiority study, V59P6, immunogenicity was assessed among adolescents aged 11-17 years who had been randomised to receive either Menveo or ACWY-PS. Menveo was shown to be non-inferior to ACWY-PS vaccine for all four serogroups (A, C, W-135 and Y) based on seroresponse, proportions achieving hSBA ≥1:8, and GMTs.
Danish: I non-inferioritetsstudiet, V59P6, blev immunogeniciteten evalueret blandt unge i alderen 11-17 år, der var randomiseret til at få enten Menveo eller ACWY-PS. Menveo var non-inferiore i forhold til ACWY-PS vaccine for alle fire serogrupper (A, C, W-135 og Y) baseret på serorespons, andele der opnåede hSBA ≥ 1:8, og GMT.
English: Using a syringe and suitable needle (21G, 40 mm length or 21G, 1 ½ inch length), withdraw the entire contents of the vial of solution and inject into the vial of powder to reconstitute the MenA conjugate component.
Danish: Med en sprøjte og en egnet kanyle (21G, 40 mm lang eller 21G, 1 ½" lang) trækkes hele indholdet ud af hætteglasset med opløsningen og injiceres i hætteglasset med pulver for at rekonstituere MenA konjugeret komponent.
English: In another study (V59P6) conducted in 524 adolescents, the immunogenicity of Menveo was compared to that of ACWY-PS.
Danish: I et andet studie (V56P6), der blev udført med 524 unge, blev immunogeniciteten af Menveo sammenlignet med immunogeniciteten i ACWY-PS.
English: At 5 years after primary vaccination, there were significantly higher percentages of subjects with hSBA ≥ 1:8 in the Menveo group than in the vaccine-naive control subjects against all the four serogroups.
Danish: 5 år efter primær vaccination var procentdelen af personer med hSBA ≥ 1:8 signifikant højere i Menveo-gruppen end hos de vaccinenaive kontrolpersoner for alle fire serogrupper.
English: Powder and solution for solution for injection (powder and solution for injection).
Danish: Pulver og opløsning til injektionsvæske, opløsning (pulver og injektionsvæske, opløsning).
English: The most common side effects reported during clinical trials usually lasted only one to two days and were not usually severe.
Danish: De almindeligste bivirkninger, som er indberettet i kliniske studier, varede normalt kun en eller to dage og var ikke alvorlige.
English: How to use Menveo
Danish: Sådan bruges Menveo
English: P Value Menveo vs ACWYPS
Danish: P-værdi Menveo vs ACWY-PS
English: Contents of the pack and other information What Menveo contains
Danish: Pakningsstørrelser og yderligere oplysninger Menveo indeholder:
English: In a randomised, observer-blind study (V59P10) conducted in Argentina, children were immunized with a single dose of either Menveo (N=949) or ACWY-PS (N=551).
Danish: I et randomiseret, observatørblindet studie (V59P10), der blev gennemført i Argentina, blev børn immuniseret med en enkelt dosis Menveo (N = 949) eller ACWY-PS (N = 551).
English: Not known: tonic convulsion, febrile convulsion, syncope Ear and labyrinth disorders
Danish: Ikke kendt: tonisk krampe, feberkrampe, synkope
English: Very common: nausea
Danish: Meget almindelige: kvalme
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo solution for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Menveo opløsning til injektion
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENCWY LIQUID CONJUGATE COMPONENT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL HÆTTEGLAS MENCWY FLYDENDE KONJUGERET KOMPONENT
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Menveo findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: - have haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).
Danish: - hvis du eller dit barn har hæmofili eller en anden lidelse, der kan forhindre blodet i at størkne, f.eks. hvis du tager blodfortyndende medicin (antikoagulanter).
English: Timepo int
Danish: Tidspun kt
English: In the 11-18 year old population of the pivotal study, V59P13, the immunogenicity of a single dose of Menveo one month post vaccination is compared with the ACWY-D. Immunogenicity results at one month after Menveo are summarized below in Table 4.
Danish: I gruppen af 11-18 årige i det pivotale studie, V56P13, blev immunogeniciteten af en enkelt dosis Menveo en måned efter vaccination sammenlignet med ACWY-D. Immunogenicitetsresultater en måned efter Menveo er angivet i tabel 4.
English: Table 6: Persistence of immune responses approximately 21 months, 3 years and 5 years after vaccination with Menveo (subjects were aged 11-18 years at the time of vaccination)
Danish: Tabel 6: Persistens af immunresponset ca. 21 måneder, 3 år og 5 år efter vaccination med Menveo (forsøgspersonerne var i alderen 11-18 år på tidspunktet for vaccinationen)
English: For children 2 to 10 years of age, no data are available for evaluating safety and immunogenicity of other childhood vaccines when administered concomitantly with Menveo.
Danish: Data til evaluering af sikkerhed og immunogenicitet af andre børnevacciner administreret samtidig med Menveo er ikke tilgængelige for børn i alderen 2-10 år.
English: Conjugated to Corynebacterium diphtheriae CRM197 protein
Danish: Konjugeret til Corynebacterium diphtheriae CRM197 protein
English: In another randomised, observer-blind study (V59P8) US children were immunized with a single dose of either Menveo (N=284) or ACWY-PS (N=285).
Danish: I et andet randomiseret, observatørblindet studie (V59P8) blev amerikanske børn immuniseret med en enkelt dosis Menveo (N = 284) eller ACWY-PS (N = 285).
English: Menveo is indicated for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y, to prevent invasive disease.
Danish: Menveo er indiceret til aktiv immunisering af børn (fra 2 år), unge og voksne med risiko for eksponering for Neisseria meningitidis-gruppe A, C, W-135 og Y til forebyggelse af invasiv sygdom.
English: In children (from 2 to 10 years of age), the side effects that were reported during clinical trials are listed below.
Danish: De bivirkninger, der blev indberettet i kliniske studier hos børn (fra 2 til 10 år), er anført nedenfor.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 March 2010
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: The immune response observed in the children 2-10 years of age was very similar to those observed in the V59P8 study shown above: immune response to Menveo at 1 month post vaccination, as measured by percentage of subjects with seroresponse, hSBA≥1:8 and GMTs, was non-inferior to ACWY-PS.
Danish: Immunresponset observeret hos børnene i alderen 2-10 år var meget lig immunresponset i V59P8-studiet ovenfor: Immunresponset på Menveo én måned efter vaccination, målt som procentdelen af forsøgspersoner med serorespons, hSBA ≥ 1:8 og GMT'ere, var non-inferiørt i forhold til ACWY-PS.
English: Immunogenicity in older adults
Danish: Immunogenicitet hos ældre
English: Serogroup hSBA ≥1:8
Danish: Serogruppe hSBA ≥ 1:8
English: • Meningococcal group W-135 oligosaccharide
Danish: • Meningokokgruppe W-135-oligosaccharid
English: Table 7: Persistence of immune responses approximately 12 months and 5 years after vaccination with Menveo and ACWY-PS (subjects were aged 11-18 years at the time of vaccination)
Danish: Tabel 7: Persistens af immunresponset ca. 12 måneder og 5 år efter vaccination med Menveo og ACWY-PS (forsøgspersonerne var i alderen 11-18 år på tidspunktet for vaccinationen)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENA LYOPHILISED CONJUGATE COMPONENT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL HÆTTEGLAS MENA FRYSETØRRET KONJUGERET KOMPONENT
English: In study V59P13E1, the persistence of immune responses against serogroups A, C, W-135 and Y was assessed at 21 months, 3 years and 5 years post primary vaccination among subjects aged 11-18 years at the time of vaccination.
Danish: Persistens af immunrespons og boosterrespons hos unge I studie V59P13E1 blev persistensen af immunresponset mod serogruppe A, C, W-135 og Y vurderet 21 måneder, 3 år og 5 år efter primær vaccination hos forsøgspersoner i alderen 11-18 år på vaccinationstidspunktet.
English: Both groups showed a robust response to the booster dose of Menveo at one month after vaccination (100% of subjects had hSBA ≥ 1:8 across serogroups) and this response largely persisted through 2 years after the booster dose for serogroups C, W-135 and Y (with 87% to 100% of subjects with hSBA ≥ 1:8 across serogroups).
Danish: Begge grupper havde et solidt respons på Menveo-boosterdosen en måned efter vaccination (100 % af forsøgspersonerne med hSBA ≥ 1:8 på tværs af serogrupper), og dette respons blev stort set opretholdt 2 år efter boosterdosis for serogruppe C, W-135 og Y (87-100 % af forsøgspersonerne med hSBA ≥ 1:8 på tværs af serogrupper).
English: In the pivotal study (V59P13), adolescents or adults received either a dose of Menveo (N = 2649) comparator vaccine ACWY-D (N = 875).
Danish: I det pivotale studie (V56P13) fik unge eller voksne enten en dosis Menveo (N = 2.649) eller komparator (ACWY-D) (N = 875).
English: After reconstitution, the medicinal product should be used immediately.
Danish: Lægemidlet skal anvendes straks efter rekonstitution.
English: Menveo Menveo ACWYPS
Danish: Menveo Menveo ACWYPS Menveo Menveo ACWYPS
English: Menveo is a vaccine that is used for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to a bacterium named Neisseria meningitidis serogroups A, C, W-135 and Y, to prevent invasive disease.
Danish: Menveo er en vaccine, der benyttes til aktiv beskyttelse af børn (fra 2 år), unge og voksne med risiko for at blive udsat for en bakterie, der kaldes Neisseria meningitidis, serogruppe A, C, W-135 og Y, som forebyggelse mod sygdom.
English: Uncommon (may affect up to 1 in 100 people): injection site itching
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer): ændringer i spisevaner, kvalme,
English: At 1 year post vaccination, Menveo continued to be statistically higher than ACWY-PS for serogroups A, W-135 and Y, as measured by percentage of subjects with hSBA≥1:8 and GMTs.
Danish: 1 år efter vaccinationen fortsatte Menveo med at være statistisk højere end ACWY-PS for serogrupperne A, W-135 og Y målt som procentdelen af forsøgspersoner med hSBA ≥ 1:8 og GMT'ere.
English: At 1 month post-first vaccination, the percentages of subjects with hSBA ≥ 1:8 were consistently higher in the Menveo group for all four serogroups (63% vs 39%, 46% vs 39%, 78% vs 59%, and 65% vs 57% for Menveo as compared to ACWY-PS for serogroups A, C, W-135, and Y, respectively).
Danish: 1 måned efter første vaccination var procentdelene af forsøgspersoner med hSBA ≥ 1:8 konsekvent højere i Menveo-gruppen for alle fire serogrupper (63 % vs. 39 %, 46 % vs. 39 %, 78 % vs. 59 % og 65 % vs. 57 % for Menveo sammenlignet med ACWY-PS for serogrupperne A, C, W-135 og Y).