FrancophonIA/ELRC3.0 huggingface dataset:
English: During the clinical development of Gardasil 9; 2,586 women (1,347 in the Gardasil 9 group vs. 1,239 in the qHPV vaccine group) reported at least one pregnancy.
Danish: I løbet af den kliniske udvikling af Gardasil 9 rapporterede 2.586 kvinder (1.347 i Gardasil 9-gruppen versus 1.239 i qHPV-vaccinationsgruppen) mindst én graviditet.
English: In a clinical trial that included 640 individuals aged 27 to 45 years and 570 individuals aged 16 to 26 years who received Gardasil 9, the safety profile of Gardasil 9 was comparable between the two age groups.
Danish: I et klinisk forsøg, som inkluderede 640 personer i alderen 27 til 45 år og 570 personer i alderen 16 til 26 år, som fik Gardasil 9, var sikkerhedsprofilen for Gardasil 9 sammenlignelig mellem de to aldersgrupper.
English: Gardasil 9 may be given to women who are breast-feeding or intend to breast-feed.
Danish: Gardasil 9 kan gives til kvinder, som ammer eller planlægger at amme.
English: If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.
Danish: Hvis den anden vaccinedosis administreres tidligere end 5 måneder efter den første dosis, skal en tredje dosis altid administreres.
English: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Danish: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Frankrig
English: Table 2: Adverse reactions reported from Post-marketing experience with qHPV vaccine System organ class
Danish: Tabel 2: Bivirkninger indberettet i forbindelse med brug af qHPV-vaccine efter markedsføring Systemorganklasse
English: For subjects receiving Gardasil 9 after receiving 3 doses of qHPV vaccine, there was an interval of at least 12 months between completion of vaccination with qHPV vaccine and the start of vaccination with Gardasil 9 with a 3-dose regimen (the time interval ranged from approximately 12 to 36 months).
Danish: For forsøgspersoner, der fik Gardasil 9 efter 3 doser qHPV-vaccine, var der et interval på mindst 12 måneder mellem endt vaccination med qHPV-vaccine og begyndelsen af vaccination med Gardasil 9 med et 3-dosis regime (tidsintervallet lå på ca. 12 til 36 måneder).
English: This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of Gardasil 9 (see section 4.8).
Danish: Dette er baseret på resultaterne fra et klinisk forsøg, hvor en kombineret dTap-IPV-vaccine blev administreret sammen med den første dosis Gardasil 9 (se pkt.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Danish: Dyreforsøg indikerer ikke reproduktionstoksicitet (se pkt.
English: Gardasil 9 has no or negligible influence on the ability to drive or use machines.
Danish: Gardasil 9 påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: No human data on the effect of Gardasil 9 on fertility are available.
Danish: Der foreligger ingen data om effekten af Gardasil 9 på menneskelig fertilitet.
English: A study documenting safety and immunogenicity of qHPV vaccine has been performed in 126 HIV infected subjects aged 7 to12 years with baseline CD4% ≥15 and at least 3 months of highly active antiretroviral therapy (HAART) for subjects with a CD4% <25 (of which 96 received qHPV vaccine).
Danish: Et studie, der dokumenterede sikkerheden og immunogeniciteten af qHPV-vaccine blev udført med 126 hiv-inficerede forsøgspersoner på mellem 7 og 12 år med baseline CD4% ≥15 og mindst 3 måneder med højaktiv antiretroviral terapi (HAART) for forsøgspersoner med CD4% <25 (hvoraf 96 fik qHPV-vaccine).
English: Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm and urticaria
Danish: Overfølsomhedsreaktioner herunder anafylaktiske/anafylaktoide reaktioner, bronkospasmer og urticaria
English: Immune response to Gardasil 9 at Month 7
Danish: Immunrespons over for Gardasil 9 ved måned 7
English: The vaccine is therefore not indicated for treatment of cervical, vulvar, vaginal and anal cancer, high-grade cervical, vulvar, vaginal and anal dysplastic lesions or genital warts.
Danish: Vaccinen er derfor ikke indiceret til behandling af cervixcancer, vulva-, vaginal- og analcancer, high-grade cervikale, vulvale, vaginale og anale dysplastiske læsioner eller kondylomer.
English: Use of hormonal contraceptives did not appear to affect the type-specific immune responses to Gardasil 9.
Danish: Det lod ikke til, at brugen af hormonelle præventionsmidler påvirkede det typespecifikke immunrespons over for Gardasil 9.
English: A total of 15,776 individuals (10,495 subjects aged 16 to 26 years and 5,281 adolescents aged 9 to 15 years at enrolment) received Gardasil 9.
Danish: I alt 15.776 personer (10.495 forsøgspersoner i alderen 16 til 26 år og 5.281 unge i alderen 9 til 15 år på inklusionsdagen) fik Gardasil 9.
English: Excipients: Sodium chloride, histidine, polysorbate 80, borax, water for injections.
Danish: Hjælpestoffer: Natriumchlorid, histidin, polysorbat 80, borax, vand til injektionsvæsker.
English: Protocols 005 and 007 evaluated Gardasil 9 concomitantly administered with vaccines recommended routinely in girls and boys aged 11 to 15 years (N=2,295).
Danish: Protokol 005 og 007 evaluerede Gardasil 9, der blev administreret samtidigt med vacciner, der rutinemæssigt anbefales til piger og drenge i alderen 11 til 15 år (N=2.295).
English: Clinical studies for Gardasil 9
Danish: Kliniske studier med Gardasil 9
English: Gardasil 9 also reduced the incidence of HPV 31-, 33-, 45-, 52-, and 58-related Pap test abnormalities, cervical and external genital procedures (i.e., biopsies), and cervical definitive therapy procedures (Table 4).
Danish: Gardasil 9 reducerede også antallet af tilfælde af HPV 31-, 33-, 45-, 52- og 58relaterede Pap-test abnormiteter, cervikale og eksterne genitale procedurer (dvs. biopsier) og cervikale definitive terapiprocedurer (Tabel 4).
English: The vaccine is not used to treat HPV related diseases.
Danish: Vaccinen er ikke beregnet til at behandle HPV-relaterede sygdomme.
English: Gardasil 9 is a vaccine for children and adolescents from 9 years of age and adults.
Danish: Gardasil 9 er en vaccine til børn og unge fra 9 år og til voksne.
English: Prior to agitation, Gardasil 9 may appear as a clear liquid with a white precipitate.
Danish: Før omrystning kan Gardasil 9 fremstå som en klar væske med et hvidt bundfald.
English: • for at least 5 years in women who were aged 16 to 26 years at time of vaccination with Gardasil 9, depending on HPV type, 78 to100 % of subjects were seropositive; however, efficacy was maintained in all subjects regardless of seropositivity status for any vaccine HPV type through the end of the study (up to 67 months postdose 3, median follow-up duration of 43 months postdose 3),
Danish: • i mindst 5 år hos kvinder på 16-26 år på tidspunktet for vaccination med Gardasil 9; afhængigt af HPV-type var 78 til 100% af forsøgspersonerne seropositive; effekten blev dog opretholdt hos alle forsøgspersoner uanset seropositivitetsstatus for alle vaccine-HPV-typer under hele studiet (op til 67 måneder efter dosis 3, median opfølgningsperiode på 43 måneder efter dosis 3).
English: The other ingredients in the vaccine suspension are: sodium chloride, histidine, polysorbate 80, borax and water for injections.
Danish: De andre indholdsstoffer i vaccinesuspensionen er: natriumchlorid, histidin, polysorbat 80, borax og vand til injektionsvæsker.
English: However, the presence of a minor infection, such as a mild upper respiratory tract infection or lowgrade fever, is not a contraindication for immunisation.
Danish: Men en mindre infektion så som en let infektion i de øvre luftveje eller en lav feber er ikke en kontraindikation for immunisering.
English: In a clinical trial of 1,053 healthy adolescents aged 11 to 15 years, administration of the first dose of Gardasil 9 concomitantly with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine showed that more injection-site reactions (swelling, erythema), headache and pyrexia were reported.
Danish: I et klinisk forsøg med 1.053 raske unge i alderen 11-15 år viste administration af den første dosis Gardasil 9 samtidig med difteri, tetanus, pertussis [acellulær, komponent] og poliomyelitis [inaktiveret] boostervaccine, at der blev rapporteret flere reaktioner på injektionsstedet (hævelse, erytem), hovedpine og pyreksi.
English: Gardasil 9 is available in packs of 1 or 10 pre-filled syringes.
Danish: Gardasil 9 fås i pakker med 1 eller 10 forfyldte sprøjter.
English: Symptoms may include difficulty breathing, wheezing, hives and/or rash.
Danish: Symptomer kan inkludere vejrtrækningsproblemer, pibende vejrtrækning, nældefeber og/eller udslæt.
English: A total of 92 women were breast-feeding during the vaccination period of the clinical studies of Gardasil 9 in women aged 16 to 26 years.
Danish: I alt 92 kvinder ammede i vaccinationsperioden i de kliniske forsøg med Gardasil 9 hos kvinder i alderen 16 til 26 år.
English: Gardasil 9 is available in a pack of 1.
Danish: Gardasil 9 fås i en pakke med 1.
English: The safety and efficacy of Gardasil 9 in children below 9 years of age have not been established.
Danish: Gardasil 9' s sikkerhed og virkning hos børn under 9 er ikke klarlagt.
English: Name and address of the manufacturer(s) responsible for batch release Merck Sharp & Dohme B.V.
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Merck Sharp & Dohme B.V.
English: Anti-HPV responses at Month 7 among girls/boys aged 9 to 15 years were comparable to anti-HPV responses in women aged 16 to 26 years in the combined database of immunogenicity studies for Gardasil 9.
Danish: Anti-HPV respons ved måned 7 blandt piger og drenge i alderen 9 til 15 år var sammenlignelig med anti-HPV responser hos kvinder i alderen 16 til 26 år i den kombinerede database for immunogenicitetsstudier for Gardasil 9.
English: Gardasil 9 does not have any effect in individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine.
Danish: Gardasil 9 har ikke nogen effekt på personer, som allerede har en aktiv infektion eller sygdom forbundet med nogen af de HPV-typer, der er i vaccinen.
English: 0.5 ml suspension in a pre-filled syringe (glass) with plunger stopper (siliconised FluroTec-laminated bromobutyl elastomer) and a tip cap (synthetic isoprene-bromobutyl blend) in pack sizes of 1 or 10 with needles or in a pack size of 10 without needles.
Danish: 0,5 ml suspension i en forfyldt injektionssprøjte (glas) med stempelprop (silikoneret FluroTeclamineret brombutyl elastomer) og en spidshætte (syntetisk isopren-brombutyl blanding) i pakningsstørrelser på 1 eller 10 med nåle eller i en pakningsstørrelse på 10 uden nåle.
English: Seropositivity to vaccine HPV types in the per protocol population ranged from 98.3 to 100% by Month 7 in individuals who received Gardasil 9.
Danish: Seropositivitet over for vaccine-HPV-typerne i per-protokol populationen lå på mellem 98,3 og 100% ved måned 7 hos personer, som fik Gardasil 9.
English: However, a mild fever or upper respiratory infection (for example having a cold) itself is not a reason to delay vaccination.
Danish: Men en lav feber eller infektion i de øvre luftveje (f.eks. en forkølelse) er ikke i sig selv grund til at udskyde vaccinationen.
English: However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines.
Danish: 4.8 “Bivirkninger” kan midlertidigt påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: These diseases include pre-cancerous lesions and cancers of the female genitals (cervix, vulva, and vagina), pre-cancerous lesions and cancers of the anus and genital warts in males and females.
Danish: Disse sygdomme inkluderer præcancer læsioner og cancer i de kvindelige kønsorganer (cervix, vulva og vagina), præcancer læsioner og cancer i anus samt kondylomer (kønsvorter) hos mænd og kvinder.
English: Common (may affect up to 1 in 10 people): side effects found at the injection site (bruising, and itching), fever, tiredness, dizziness and nausea.
Danish: Almindelig (kan påvirke op til 1 ud af 10 personer): bivirkninger på injektionsstedet (blåt mærke og kløe), feber, træthed, svimmelhed og kvalme.
English: No clinical study of Gardasil 9 was conducted in HIV-infected individuals.
Danish: Der er ikke udført kliniske studier med Gardasil 9 hos hiv-inficerede personer.
English: What other important information should you or your child know about Gardasil 9
Danish: Hvilke andre vigtige oplysninger skal du eller dit barn have om Gardasil 9
English: Persistent infection detected in samples from three or more consecutive visits 6 months (±1 month visit windows) apart.
Danish: Persistent infektion registreret i prøver fra tre eller flere på hinanden følgende besøg med 6 måneders mellemrum (±1 måneds besøgsvindue).
English: In Protocol 001, GMTs for HPV-6, -11, -16 and -18 were comparable in subjects who received qHPV vaccine or Gardasil 9 for at least 3.5 years.
Danish: I Protokol 001 var GMT'er for HPV-6, -11, -16 og -18 sammenlignelige hos forsøgspersoner, som fik qHPV-vaccine eller Gardasil 9 i mindst 3,5 år.
English: Persistence of immune response to Gardasil 9
Danish: Persistens af immunrespons over for Gardasil 9
English: A statistical analysis of non-inferiority was performed at Month 7 comparing cLIA anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 GMTs between individuals administered Gardasil 9 and individuals administered Gardasil.
Danish: Der blev udført en statistisk analyse af ikke-inferiøritet ved måned 7, som sammenlignede cLIA antiHPV 6, anti-HPV 11, anti-HPV 16 og anti-HPV 18 GMT'er blandt personer, som fik Gardasil 9 og personer, som fik Gardasil.
English: In the same study, in girls and boys aged 9 to14 years, GMTs at one month after the last vaccine dose were numerically lower for some vaccine types after a 2-dose schedule than after a 3-dose schedule (i.e., HPV types 18, 31, 45, and 52 after 0, 6 months and HPV type 45 after 0, 12 months).
Danish: I det samme studie med piger og drenge i alderen 9 til 14 år, var GMTer en måned efter den sidste vacccinedosis numerisk lavere for nogle vaccinetyper efter en 2-dosis tidsplan end efter en 3-dosis tidsplan (dvs. HPV-typer 18, 31, 45 og 52 efter 0, 6 måneder og HPV-type 45 efter 0, 12 måneder).
English: A subset of subjects is being followed up for 10 to 14 years after Gardasil 9 vaccination for safety, immunogenicity, and effectiveness against clinical diseases related to the HPV types in the vaccine.
Danish: En undergruppe af forsøgspersoner følges i op til 10 til 14 år efter vaccination med Gardasil 9 for sikkerhed, immunogenicitet og beskyttelse mod kliniske sygdomme relateret til HPV-typerne i vaccinen.
English: Efficacy against HPV types 6, 11, 16, and 18 was primarily assessed using a bridging strategy that demonstrated comparable immunogenicity (as measured by Geometric Mean Titres [GMT]) of Gardasil 9 compared with qHPV vaccine (Protocol 001, GDS01C/Protocol 009 and GDS07C/Protocol
Danish: Effekten mod HPV-type 6, 11, 16 og 18 blev primært vurderet vha. en bridging strategi, som påviste sammenlignelig immunogenicitet (som målt ved geometriske middeltitre [GMT]) af Gardasil 9 sammenlignet med qHPV-vaccine (Protokol 001, GDS01C/Protokol 009 og GDS07C/Protocol 020).
English: One month following the last dose of the assigned regimen, between 97.9% and 100% of subjects across all groups became seropositive for antibodies against the 9 vaccine HPV types.
Danish: En måned efter den sidste dosis af det tildelte regimen blev mellem 97,9% og 100% af forsøgspersoner i alle grupper seropositive over for de 9 vaccine HPV-typer.
English: Persistent infection detected in samples from two or more consecutive visits 6 months (±1 month visit windows) apart.
Danish: Persistent infektion registreret i prøver fra to eller flere på hinanden følgende besøg med 6 måneders mellemrum (±1 måneds besøgsvindue).
English: Pre-filled syringe with 2 needles, pack of 1, 10
Danish: Forfyldt sprøjte med 2 nåle, pakning med 1, 10
English: The genotypes for the vaccine comprised of HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58 will be referred to as vaccine HPV types.
Danish: Genotyperne for vaccinen omfattende HPV-typerne 6, 11, 16, 18, 31, 33, 45, 52, 58 vil blive omtalt som vaccine-HPV-typer.
English: Gardasil 9 was efficacious in preventing HPV 31-, 33-, 45-, 52-, and 58-related persistent infection and disease (Table 4).
Danish: Gardasil 9 var effektiv til at forebygge HPV 31-, 33-, 45-, 52- og 58-relateret persistent infektion og sygdom (Tabel 4).
English: It is important that you follow your doctor or nurse's instructions regarding return visits for the followup doses.
Danish: Det er vigtigt, at du følger din læges eller sygeplejerskes anvisninger ang.
English: When Gardasil 9 is given as your first dose, the completion of the vaccination course should be done with Gardasil 9, and not another HPV vaccine.
Danish: Når Gardasil 9 gives som din første dosis, bør vaccinationsprogrammet fuldføres med Gardasil 9 og ikke en anden HPV-vaccine.
English: Efficacy evaluation of Gardasil 9 against cervical high grade diseases caused by vaccine HPV types in the PPE
Danish: Effektevaluering af Gardasil 9 mod high-grade cervikale sygdomme forårsaget af vaccine-HPVtyperne i PPE
English: Protocol 006 evaluated the immunogenicity of Gardasil 9 in 921 girls and women (aged 12 to 26 years) who had previously been vaccinated with qHPV vaccine.
Danish: Protokol 006 evaluerede immunogeniciteten af Gardasil 9 hos 921 piger og kvinder (i alderen 12 til 26 år), som tidligere var blevet vaccineret med qHPV-vaccine.
English: HPV 31-, 33-, 45-, 52-, 58-related Persistent Infection ≥6 Months HPV 31-, 33-, 45-, 52-, 58-related Persistent Infection ≥12 Months HPV 31-, 33-, 45-, 52-, 58-related ASC-US HR-HPV Positive or Worse Pap Abnormality
Danish: HPV 31-, 33-, 45-, 52-, 58-relateret persistent infektion ≥6 måneder HPV 31-, 33-, 45-, 52-, 58-relateret persistent infektion ≥12 måneder HPV 31-, 33-, 45-, 52-, 58-relateret ASC-US HR-HPV-positiv eller værre Pap abnormitet
English: Gardasil 9 administered to female rats had no effects on development, behaviour, reproductive performance or fertility of the offspring.
Danish: Gardasil 9 administreret til hunrotter havde ikke nogen effekt på afkommets udvikling, adfærd, forplantningsevne eller fertilitet.
English: It uses the same amorphous aluminium hydroxyphosphate sulfate adjuvant as qHPV vaccine.
Danish: Den bruger den samme amorfe aluminiumhydroxyphosphat-sulfat-adjuvans som qHPV-vaccine.
English: Individuals 15 years of age and older at time of first injection Gardasil 9 should be administered according to a 3-dose (0, 2, 6 months) schedule.
Danish: Personer på 15 år og ældre på første injektionstidspunkt Gardasil 9 skal administreres i henhold til en 3-dosis (0, 2, 6 måneder) tidsplan.
English: • Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine
Danish: • Præmaligne læsioner og cancerformer, der rammer cervix, vulva, vagina og anus, forårsaget af vaccine-HPV-typer.
English: Gardasil 9 does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination.
Danish: Gardasil 9 forebygger ikke læsioner, der er forårsaget af en vaccine-HPV-type, hos personer, som er inficeret med den HPV-type på vaccinationstidspunktet.
English: It is prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein from the same four HPV types (6, 11, 16, 18) in qHPV vaccine and from 5 additional HPV types (31, 33, 45, 52, 58).
Danish: Den fremstilles af højtoprensede viruslignende partikler (VLP'er) af det vigtigste kapsid L1 protein fra de samme fire HPV-typer (6, 11, 16, 18) i qHPV-vaccine og fra 5 yderligere HPV-typer (31, 33, 45, 52, 58).
English: Immune responses to Gardasil 9 using a 2-dose schedule in individuals 9 through 14 years of age
Danish: Immunrespons over for Gardasil 9, når der anvendes en 2-dosis tidsplan hos personer fra 9 til og med 14 år.
English: Single dose vial, pack of 1
Danish: Enkelt-dosis hætteglas, pakning med 1
English: 0.5 ml suspension in a vial (glass) with stopper (halobutyl) and a flip-off plastic cap (aluminium crimp band) in a pack size of 1.
Danish: 0,5 ml suspension i et hætteglas (glas) med prop (halobutyl) og flip-off plasthætte (aluminium krympebånd) i en pakningsstørrelse på 1.
English: Impact of Gardasil 9 against cervical biopsy and definite therapy related to vaccine HPV types in the PPE
Danish: Virkning af Gardasil 9 mod cervikale biopsier og definitiv terapi relateret til vaccine-HPVtyperne i PPE
English: • Withdraw the 0.5 ml dose of vaccine from the vial using a sterile needle and syringe.
Danish: • Træk en 0,5 ml dosis af vaccinen ud af hætteglasset med en steril nål og sprøjte.
English: There are no data on the use of Gardasil 9 in individuals with impaired immune responsiveness.
Danish: Der foreligger ingen data om brugen af Gardasil 9 hos personer med nedsat immunforsvar.
English: Gardasil 9 suspension for injection.
Danish: Gardasil 9 suspension til injektion.
English: L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
Danish: L1 protein i form af viruslignende partikler dannet i gærceller (Saccharomyces cerevisiae CANADE 3C-5 (stamme 1895)) vha. rekombinant DNA-teknologi.
English: Subjects previously vaccinated with a 3-dose regimen of quadrivalent HPV types 6, 11, 16, and 18 vaccine (Gardasil), hereafter referred to as qHPV vaccine, may receive 3 doses of Gardasil 9 (see section 5.1).
Danish: Forsøgspersoner, som tidligere er blevet vaccineret med et 3-dosis regime af kvadrivalent HPV-type 6, 11, 16 og 18 vaccine (Gardasil), herefter kaldet qHPV-vaccine, kan få 3 doser af Gardasil 9 (se pkt.
English: In a clinical trial, persistence of antibody response has been demonstrated for at least 5 years in girls aged 9 to13 years who received 2 doses of qHPV vaccine.
Danish: I et klinisk studie sås vedvarende antistofrespons i mindst 5 år hos piger i alderen 9 til 13 år, som havde fået 2 doser qHPV-vaccine.
English: • Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and syringe.
Danish: • Træk en 0,5 ml vaccinedosis ud af enkelt-dosis hætteglasset vha. en steril nål og sprøjte.
English: On the basis of this immunogenicity bridging, the efficacy of a 2dose regimen of Gardasil 9 in girls and boys aged 9 to 14 years is inferred.
Danish: På baggrund af denne immunogenicitetssammenligning, udledes effektiviteten af et 2dosisregime af Gardasil 9 hos piger og drenge i alderen 9 til 14 år.
English: Table 3: Comparison of immune responses (based on cLIA) between Gardasil 9 and qHPV vaccine for HPV types 6, 11, 16, and 18 in the PPI (Per Protocol Immunogenicity)* population of 9 to 15 year-old girls and 16 to 26 year old women and men
Danish: Tabel 3: Sammenligning af immunrespons (baseret på cLIA) mellem Gardasil 9 og qHPV-vaccine for HPV-type 6, 11, 16 og 18 i PPI (Per Protocol Immunogenicity)*-populationen med piger i alderen 9 til 15 år og mænd og kvinder i alderen 16 til 26 år.
English: Suspension for injection 10 pre-filled syringes (0.5 ml)
Danish: Suspension til injektion 10 forfyldte sprøjter (0,5 ml)
English: • demonstration of efficacy against persistent infection and disease related to HPV types 31, 33, 45, 52 and 58 in girls and women aged 16 to 26 years, and
Danish: • påvisning af effekt mod persistente infektioner og sygdomme relateret til HPV-type 31, 33, 45, 52 og 58 hos piger og kvinder i alderen 16 til 26 år, og
English: Table 4: Analysis of efficacy of Gardasil 9 against HPV types 31, 33, 45, 52, and 58 in the PPE population of 16 to 26 year old women
Danish: Tabel 4: Analyse af effekten af Gardasil 9 mod HPV-type 31, 33, 45, 52 og 58 i PPE ‡-populationen med kvinder i alderen 16 til 26 år