FrancophonIA/ELRC3.0 huggingface dataset:
English: GDS07C/Protocol 020 evaluated immunogenicity of Gardasil 9 in men aged 16 to 26 years (N=500; 249 receiving Gardasil 9 and 251 receiving qHPV vaccine).
Maltese: GDS07C/Protokoll 020 ivvaluta l-immunoġeniċità ta' Gardasil 9 f'irġiel b'età minn 16 sa 26 sena (N=500; 249 rċivew Gardasil 9 u 251 rċivew il-vaċċin qHPV).
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).
Maltese: Il-Protokolli 005 u 007 ivvalutaw Gardasil 9 mogħti flimkien ma' vaċċini rakkomandati bħala rutina fi bniet u subien b'età minn 11 sa 15-il sena (N=2,295).
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż..
English: The safety profile was similar to non-HIV infected subjects in other studies.
Maltese: Il-profil tas-sigurtà kien simili għal dak ta' individwi mhux infettati bl-HIV fi studji oħra.
English: Arthralgia, myalgia
Maltese: Mhux magħrufa Artralġja, mijalġja
English: GDS01C/Protocol 009 evaluated immunogenicity of Gardasil 9 in girls aged 9 to 15 years (N=600; 300 receiving Gardasil 9 and 300 receiving qHPV vaccine).
Maltese: GDS01C/Protokoll 009 ivvaluta l-immunoġeniċità ta' Gardasil 9 fi bniet b'età minn 9 snin sa 15-il sena (N=600; 300 rċevew Gardasil 9 u 300 rċevew il-vaċċin qHPV).
English: Seroconversion to all four antigens occurred in more than 96% of the subjects.
Maltese: Serokonverżjoni għall-erba' antiġens kollha seħħet f'aktar minn 96% tal-individwi.
English: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon France
Maltese: MSD VACCINS 162 avenue Jean Jaurès
English: Immunogenicity was measured by (1) the percentage of individuals who were seropositive for antibodies against the relevant vaccine HPV type, and (2) the Geometric Mean Titre (GMT).
Maltese: L-immunoġeniċità tkejlet permezz (1) tal-perċentwal ta' individwi li kienu seropożittivi għal antikorpi kontra t-tip ta' HPV rilevanti tal-vaċċin, u (2) tat-Titre Medju Ġeometriku (GMT - Geometric Mean Titre).
English: Gardasil 9 can be administered according to a 3-dose (0, 2, 6 months) schedule.
Maltese: Gardasil 9 jista' jingħata skont skeda ta' 3 dożi (0, 2, 6 xhur).
English: The other ingredients in the vaccine suspension are: sodium chloride, histidine, polysorbate 80, borax and water for injections.
Maltese: Is-sustanzi l-oħra fis-suspensjoni tal-vaċċin huma: sodium chloride, histidine, polysorbate 80, borax u ilma għall-injezzjonijiet.
English: Immunogenicity in HIV infected subjects
Maltese: Immunoġeniċità f'individwi infettati bl-HIV
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
Maltese: Tabella 4: Analiżi tal-effikaċja ta' Gardasil 9 kontra t-tipi 31, 33, 45, 52, u 58 ta' HPV fil-popolazzjoni PPE‡ ta' nisa li kellhom minn 16 sa 26 sena
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).
Maltese: HIV b'età minn 7 snin sa 12-il sena b'CD4% ta' ≥15 fil-linja bażi u mill-inqas 3 xhur ta' terapija antiretrovirali attiva ħafna (HAART - highly active antiretroviral therapy) għal individwi b'CD4% ta' <25 (li 96 minnhom irċevew il-vaċċin qHPV).
English: The minimum anti-HPV titre that confers protective efficacy has not been determined.
Maltese: S'issa għadu ma ġiex stabbilit it-titre minimu kontra HPV li jagħti effikaċja protettiva.
English: 30 micrograms
Maltese: 30 mikrogramma
English: The qHPV vaccine was used as an active control during the clinical development program for Gardasil 9.
Maltese: Il-vaċċin qHPV intuża bħala kontroll attiv waqt ilprogramm ta' żvilupp kliniku ta' Gardasil 9.
English: Gardasil 9 will not protect against every type of Human Papillomavirus.
Maltese: Gardasil 9 ma jipproteġix kontra kull tip ta' Papillomavirus Uman.
English: Protocol 004 evaluated immunogenicity of Gardasil 9 in women aged 16 to 45 years (N=1,210: 640 women aged 27 to 45 years and 570 women aged 16 to 26 years).
Maltese: Protokoll 004 ivvaluta l-immunoġeniċità ta' Gardasil 9 f'nisa b'età minn 16 sa 45 sena (N=1,210: 640 mara b'età minn 27 sa 45 sena u 570 mara b'età minn 16 sa 26 sena).
English: Immune responses, measured by GMT, for Gardasil 9 were non-inferior to immune responses for Gardasil (Table 3).
Maltese: Ir-risponsi immuni, imkejla permezz ta' GMT, għal Gardasil 9 ma kinux inferjuri għar-risponsi immuni għal Gardasil (Tabella 3).
English: As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs and upper body, or confusion (Guillain-Barré syndrome, acute disseminated encephalomyelitis); vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, bleeding or bruising more easily than normal and skin infection at the injection site.
Maltese: Bħal ma jiġri b'vaċċini oħra, l-effetti sekondarji li ġew irrappurtati matul l-użu ġenerali jinkludu: glandoli minfuħin (għonq, l-abt, jew l-irqiq ta' bejn iż-żaqq u l-koxxa); dgħufija fil-muskoli, sensazzjonijiet mhux normali, tingiż fid-dirgħajn, fir-riġlejn u fil-parti ta' fuq tal-ġisem, jew konfużjoni (sindrome ta' Guillain-Barré, enċefalomijelite akuta u mifruxa); rimettar, uġigħ fil-ġogi, uġigħ fil-muskoli, għeja mhux tas-soltu jew dgħufija, tkexkix ta' bard, tħossok ma tiflaħx b'mod ġenerali, ikollok ħruġ ta' demm jew titbenġel b'mod aktar faċli mis-soltu u infezzjoni fil-ġilda fil-post tal-injezzjoni.
English: Based on epidemiology studies, Gardasil 9 is anticipated to protect against the HPV types that cause approximately: 90% of cervical cancers, more than 95% of adenocarcinoma in situ (AIS), 75-85% of high-grade cervical intraepithelial neoplasia (CIN 2/3), 85-90% of HPV related vulvar cancers, 90-95% of HPV related high-grade vulvar intraepithelial neoplasia (VIN 2/3), 80-85% of HPV related vaginal cancers, 75-85% of HPV related high-grade vaginal intraepithelial neoplasia (VaIN 2/3),
Maltese: Abbażi ta' studji epidemjoloġiċi, Gardasil 9 huwa antiċipat li jipproteġi kontra t-tipi ta' HPV li jikkawżaw madwar: 90% tal-kanċers tal-għonq tal-utru, aktar minn 95% tal-adenokarċinoma in situ (AIS - adenocarcinoma in situ), 75-85% tan-neoplażja ta' grad għoli ġewwa ċ-ċellula tal-epitelju talgħonq tal-utru (CIN 2/3 - cervical intraepithelial neoplasia grade 2/3), 85-90% tal-kanċers tal-vulva marbuta ma' HPV, 90-95% tan-neoplażja ta' grad għoli ġewwa ċ-ċellula tal-epitelju tal-vulva (VIN 2/3 - vulvar intraepithelial neoplasia grade 2/3) marbuta ma' HPV, 80-85% tal-kanċers tal-vaġina marbuta ma' HPV, 75-85% tan-neoplażja ta' grad għoli ġewwa ċ-ċellula tal-epitelju tal-vaġina (VaIN
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.
Maltese: 15,776 individwu (10,495 individwu b'eta minn 16 sa 26 sena u 5,281 adolexxent b'età minn 9 snin sa
English: In Protocol 004, anti-HPV antibody GMTs at Month 7 among women aged 27 to 45 years were noninferior to anti-HPV antibody GMTs among girls and women aged 16 to 26 years for HPV 16, 18, 31, 33, 45, 52, and 58 with GMT ratios between 0.66 and 0.73.
Maltese: Fi Protokoll 004, GMTs tal-antikorpi kontra HPV f'Xahar 7 fost nisa b'età minn 27 sa 45 sena ma kinux inferjuri għal GMTs tal-antikorpi kontra HPV fost bniet u nisa b'età minn 16 sa 26 sena għal HPV 16, 18, 31, 33, 45, 52, u 58 bi proporzjonijiet ta' GMT bejn 0.66 u 0.73. F'analiżi post hoc għal
English: 1 dose of Gardasil 9 suspension for injection contains 0.5 ml.
Maltese: Doża waħda ta' suspensjoni għall-injezzjoni ta' Gardasil 9 fiha 0.5 ml.
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
Maltese: Tabella 3: Tqabbil tar-risponsi immuni (abbażi ta' cLIA) bejn Gardasil 9 u l-vaċċin qHPV għat-tipi 6, 11, 16, u 18 ta' HPV fil-popolazzjoni PPI (Per Protocol Immunogenicity, Immunoġeniċità Skont ilProtokoll)* ta' bniet li kellhom minn 9 snin sa 15-il sena u nisa u rġiel li kellhom minn 16 sa 26 sena
English: Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
Maltese: Vaċċin b'9 tipi ta' Papillomavirus Uman (Rikombinanti, adsorbit)
English: Safety and immunogenicity of a qHPV vaccine have been assessed in individuals aged 7 to 12 years who are known to be infected with Human Immunodeficiency Virus (HIV) (see section 5.1).
Maltese: Is-sigurtà u l-immunoġeniċità ta' vaċċin qHPV ġew ivvalutati f'individwi b'età minn 7 snin sa 12-il sena magħrufa li kienu infettati bil-Virus tal-Immunodefiċjenza Umana (HIV - human immunodeficiency virus) (ara sezzjoni 5.1).
English: • for at least 5 years in girls and boys who were aged 9 to 15 years at time of vaccination with Gardasil 9; depending on HPV type, 90 to 99 % of subjects were seropositive.
Maltese: • għal mill-inqas 5 snin fi bniet u subien li kellhom età minn 9 snin sa 15-il sena fiż-żmien tattilqim b'Gardasil 9; skont it-tip ta' HPV, 90 sa 99 % tal-individwi kienu seropożittivi.
English: Protocol 002 evaluated immunogenicity of Gardasil 9 in girls and boys aged 9 to 15 years and women aged 16 to 26 years (N=3,066: 1,932 girls; 666 boys; and 468 women receiving Gardasil 9).
Maltese: Protokoll 002 ivvaluta l-immunoġeniċità ta' Gardasil 9 fi bniet u subien b'età minn 9 snin sa 15-il sena u nisa b'età minn 16 sa 26 sena (N=3,066: 1,932 tifla; 666 tifel; u 468 mara rċevew Gardasil 9).
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.
Maltese: Fi prova klinika ta' 1,053 adolexxent f'saħħithom b'età minn 11 sa 15-il sena, l-għoti tal-ewwel doża ta' Gardasil 9 flimkien ma' vaċċin ta' rinforz ikkombinat ta'difterite, tetnu, pertussis [aċellulari, komponent] u poljomijelite [inattivat] wera li ġew irrappurtati aktar reazzjonijiet fis-sit tal-injezzjoni (nefħa, eritema), uġigħ ta' ras u deni.
English: adsorbed on amorphous aluminium hydroxyphosphate sulfate adjuvant (0.5 milligrams Al).
Maltese: 3Adsorbit fuq aluminium hydroxyphosphate sulfate amorfu awżiljari (0.5 milligrammi Al).
English: Table 1: Adverse reactions following administration of Gardasil 9 occurring with a frequency of at least 1.0% from clinical trials*
Maltese: Tabella 1: Reazzjonijiet avversi wara l-għoti ta' Gardasil 9 li seħħew bi frekwenza ta' mill-inqas 1.0%
English: Gardasil 9 suspension for injection.
Maltese: Gardasil 9 suspensjoni għall-injezzjoni.
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.
Maltese: 0.5 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ) b'tapp li jwaqqaf il-planġer (elastomer talbromobutyl silikonizzat laminat bi FluroTec) u għatu fit-tarf (taħlita sintetika ta' isoprene-bromobutyl) f'daqsijiet ta' pakkett ta' 1 jew 10 bil-labar jew daqs ta' pakkett ta' 10 mingħajr labar.
English: Protocol 010 evaluated the immunogenicity of 2 doses of Gardasil 9 in girls and boys aged 9 to 14 years and 3 doses of Gardasil 9 in girls aged 9 to 14 years and women aged 16 to 26 years (N=1,518; 753 girls; 451 boys and 314 women).
Maltese: Protokoll 010 ivvaluta l-immunoġeniċità ta' 2 dożi ta' Gardasil 9 fi bniet u subien b'età minn 9 snin sa 14-il sena u 3 dożi ta' Gardasil 9 fi bniet b'età minn 9 snin sa 14-il sena u nisa b'età minn 16 sa 26 sena (N = 1,518; 753 tifla; 451 tifel u 314-il mara).
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).
Maltese: Huwa jiġi ppreparat minn partiċelli qishom virus ippurifikati ħafna (VLPs - virus-like particles) tal-proteina L1 prinċipali tal-kapsula mill-istess erba' tipi ta' HPV (6, 11, 16, 18) fil-vaċċin qHPV u minn 5 tipi (31, 33, 45, 52, 58) addizzjonali ta' HPV.
English: Gardasil 9 suspension for injection Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
Maltese: Gardasil 9 suspensjoni għall-injezzjoni Vaċċin b'9 tipi ta' Papillomavirus Uman (Rikombinanti, adsorbit)
English: Protocol 003 evaluated immunogenicity of Gardasil 9 in men aged 16 to 26 years and women aged 16 to 26 years (N=2,515:1,103 Heterosexual Men [HM]; 313 Men Who Have Sex with Men [MSM]; and 1,099 women receiving Gardasil 9).
Maltese: Protokoll 003 ivvaluta l-immunoġeniċità ta' Gardasil 9 f'irġiel b'età minn 16 sa 26 sena u f'nisa b'età minn 16 sa 26 sena (N=2,515: 1,103 Irġiel Eterosesswali [HM - Heterosexual Men]; 313-il Raġel li Jkollhom x'Jaqsmu mal-Irġiel [MSM - Men Who Have Sex with Men]; u 1,099 mara rċevew Gardasil 9).
English: Gardasil 9 suspension for injection:
Maltese: Gardasil 9 suspensjoni għall-injezzjoni:
English: Persistence of immune response to Gardasil 9
Maltese: Il-persistenza tar-rispons immuni għal Gardasil 9
English: Protocol 006 evaluated administration of Gardasil 9 to girls and women aged 12 to 26 years previously vaccinated with qHPV vaccine (N=921; 615 receiving Gardasil 9 and 306 receiving placebo).
Maltese: Protokoll 006 ivvaluta l-għoti ta' Gardasil 9 lil bniet u nisa b'età minn 12 sa 26 sena li qabel kienu tlaqqmu bil-vaċċin qHPV (N=921; 615 rċevew Gardasil 9 u 306 rċevew plaċebo).
English: • developed an allergic reaction after receiving a dose of Gardasil or Silgard (HPV types 6, 11, 16, and 18) or Gardasil 9.
Maltese: • żviluppajtu reazzjoni allerġika wara li rċevejtu doża ta' Gardasil jew Silgard (tipi 6, 11, 16, u 18 ta' HPV) jew Gardasil 9.
English: Idiopathic thrombocytopaenic purpura, lymphadenopathy
Maltese: Mhux magħrufa Purpura tromboċitopenika idjopatika,
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.
Maltese: Protokoll 006 ivvaluta l-immunoġeniċità ta' Gardasil 9 f'921 tifla u mara (b'età minn 12 sa 26 sena) li qabel kienu diġà tlaqqmu bil-vaċċin qHPV.
English: Human Papillomavirus 9-valent Vaccine
Maltese: Vaċċin b'9 tipi ta' Papillomavirus Uman
English: HPV Type 11 and 18 L1 protein
Maltese: Proteina L1 ta' HPV tat-Tipi 11 u 18
English: 90-95% of HPV related anal cancer, 85-90% of HPV related high-grade anal intraepithelial neoplasia (AIN 2/3), and 90% of genital warts.
Maltese: 2/3 - vaginal intraepithelial neoplasia grade 2/3) marbuta ma' HPV, 90-95% tal-kanċer tal-anus marbut ma' HPV, 85-90% tan-neoplażja ta' grad għoli ġewwa ċ-ċellula tal-epitelju tal-anus (AIN 2/3anal intraepithelial neoplasia grade 2/3), u 90% tal-felul ġenitali.
English: Allergic reactions have been reported.
Maltese: Ġew irrappurtati reazzjonijiet allerġiċi.
English: Merck Sharp & Dohme Corp. 770 Sumneytown Pike West Point, Pennsylvania, 19486, USA
Maltese: West Point, Pennsylvania, 19486, L-Istati Uniti tal-Amerika
English: Few individuals (0.1%) discontinued due to adverse experiences.
Maltese: Ftit mill-individwi (0.1%) waqfu minħabba esperjenzi avversi.
English: Immune responses to Gardasil 9 using a 2-dose schedule in individuals 9 through 14 years of age
Maltese: Risponsi immuni għal Gardasil 9 bl-użu ta' skeda ta' 2 dożi f'individwi li għandhom minn 9 snin sa 14-il sena
English: Gardasil 9 induced robust anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, and anti-HPV 58 responses measured at Month 7, in
Maltese: Gardasil 9 induċa risponsi b'saħħithom kontra HPV 6, kontra HPV 11, kontra HPV 16, kontra HPV 18, kontra HPV 31, kontra HPV 33, kontra HPV 45, kontra HPV 52, u kontra HPV 58 imkejla fix-Xahar 7, fil-Protokolli 001, 002, 004, 005, 007, u GDS01C/Protokoll 009.
English: In Protocol 020/GDS07C, anti-HPV antibody GMTs at Month 7 among boys and men (HM) aged 16 to 26 years were comparable to anti-HPV antibody GMTs among boys and men (HM) aged 16 to 26 years administered with the qHPV vaccine for HPV 6, 11, 16 and 18.
Maltese: 26 sena (HM) kienu komparabbli ma' GMTs ta' antikorpi kontra HPV fost subien u rġiel (HM) b'età minn 16 sa 26 sena (HM) li ngħataw il-vaċċin qHPV għal HPV 6, 11, 16 u 18.
English: The CD4% or plasma HIV RNA was not affected by vaccination.
Maltese: IsCD4% jew l-RNA tal-HIV fil-plażma ma kinux affettwati mit-tilqim.
English: In clinical studies, 60.2% of women aged 16 to 26 years who received Gardasil 9 used hormonal contraceptives during the vaccination period of the clinical studies.
Maltese: Fi studji kliniċi, 60.2% tan-nisa b'età minn 16 sa 26 sena li rċevew Gardasil 9 kienu qed jużaw kontraċettivi tal-ormoni waqt il-perjodu ta' tilqim tal-istudji kliniċi.
English: Clinical trials
Maltese: KLINIKU
English: Vaccination should be postponed until completion of pregnancy (see section 5.1).
Maltese: It-tilqim għandu jiġi pospost sa wara t-tqala (ara sezzjoni 5.1).
English: The efficacy of Gardasil 9 against cervical biopsy related to vaccine HPV types compared to qHPV vaccine was 95.9% (95% CI 92.7, 97.9) with 11/6,016 versus 262/6,018 cases.
Maltese: L-effikaċja ta' Gardasil 9 kontra l-bijopsija tal-għonq tal-utru marbuta mat-tipi tal-HPV tal-vaċċin imqabbla mal-vaċċin qHPV kienet ta' 95.9% (CI ta' 95% 92.7, 97.9) bi 11/6,016-il każ kontra 262/6,018-il każ.
English: The efficacy of Gardasil 9 against CIN 2 and worse related to vaccine HPV types compared to qHPV vaccine was 94.4% (95% CI 78.8, 99.0) with 2/5,952 versus 36/5,947 cases.
Maltese: L-effikaċja ta' Gardasil 9 kontra CIN 2 u agħar marbuta mat-tipi tal-HPV tal-vaċċin mqabbla mal vaċċin qHPV kienet ta' 94.4% (CI ta' 95% 78.8, 99.0) b'2/5,952 każijiet kontra 36/5,947 każ.
English: HPV 31-, 33-, 45-, 52-, 58-related CIN2
Maltese: HPV 31, 33, 45, 52, 58
English: Immunogenicity bridging from qHPV Vaccine to Gardasil 9 for HPV types 6, 11, 16, 18
Maltese: Immunoġeniċità komuni bejn Vaċċin qHPV u Gardasil 9 għat-tipi 6, 11, 16, 18 ta' HPV
English: Individuals 9 to and including 14 years of age at time of first injection Gardasil 9 can be administered according to a 2-dose (0, 6 - 12 months) schedule (see section 5.1).
Maltese: Individwi li jkollhom minn 9 snin sa u inkluż 14-il sena meta tingħata l-ewwel injezzjoni Gardasil 9 jista' jingħata skont skeda ta' 2 dożi (0, 6 - 12-il xahar) (ara sezzjoni 5.1).
English: Impact of Gardasil 9 against cervical biopsy and definite therapy related to vaccine HPV types in the PPE
Maltese: L-impatt ta' Gardasil 9 kontra l-biopsija tal-għonq tal-utru u terapija definittiva marbuta mattipi tal-HPV tal-vaċċin fil-PPE
English: Gardasil 9 may be administered concomitantly with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) with no significant interference with antibody response to any of the components of either vaccine.
Maltese: Gardasil 9 jista' jingħata flimkien ma' vaċċin ta' rinforz ikkombinat li fih difterite (d) u tetnu (T) ma' pertussis [aċellulari, komponent] (ap) u/jew poljomijelite [inattivat] (IPV) (vaċċini dTap, dT-IPV, dTap-IPV) mingħajr l-ebda tfixkil sinifikanti fir-rispons tal-antikorpi għal kwalunkwe wieħed mill komponenti taż-żewġ vaċċini.
English: Gardasil 9 can be given with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) at a separate injection site (another part of your body, for example the other arm or leg) during the same visit.
Maltese: Gardasil 9 jista' jingħata ma' vaċċin ta' rinforz ikkombinat li fih id-difterite (d - diphtheria) u ttetnu (T - tetanus) jew mal-pertussi [aċellulari, komponent] (ap - acellular pertussis) u/jew inkella poljomijelite [mhux attivat] (IPV - inactivated poliomyelitis) (vaċċini dTap, dT-IPV, dTap-IPV) f'sit differenti tal-injezzjoni (f'parti oħra ta' ġismek, bħal driegħ jew riġel ieħor) waqt l-istess vista.
English: Dizziness
Maltese: Proporzjon
English: • demonstration of non-inferior immunogenicity against the Gardasil 9 HPV types in boys and girls aged 9 to 15 years, men aged 16 to 26 years and women aged 27 to 45 years, compared to girls and women aged 16 to 26 years.
Maltese: • intweriet immunoġeniċità mhux inferjuri kontra t-tipi ta' HPV ta' Gardasil 9 f'subien u bniet b'età minn 9 snin sa 15-il sena, f'irġiel b'età minn 16 sa 26 sena u f'nisa b'età minn 27 sa 45 sena, meta mqabbla ma' bniet u nisa b'età minn 16 sa 26 sena.
English: For instructions on the handling of the vaccine before administration, see section 6.6.
Maltese: Għal struzzjonijiet dwar l-immaniġġjar tal-vaċċin qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Maltese: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, L-Olanda Għal kull tagħrif dwar din il-mediċina, jekk jogħġbok ikkuntattja lir-rappreżentant lokali tad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: The most common adverse reactions observed with Gardasil 9 were injection-site adverse reactions (84.8% of vaccinees within 5 days following any vaccination visit) and headache (13.2% of the vaccinees within 15 days following any vaccination visit).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni li ġew osservati b'Gardasil 9 kienu reazzjonijiet avversi fis-sit tal-injezzjoni (84.8% tal-persuni mlaqqma fi żmien 5 ijiem minn kwalunkwe vista tat-tilqim) u uġigħ ta' ras (13.2% tal-persuni mlaqqma fi żmien 15-il jum wara kwalunkwe vista tat-tilqim).
English: Stonewall Plant
Maltese: Ż-ŻGĦAR EWLENIN
English: Protocol 010 measured HPV antibody responses to the 9 HPV types after Gardasil 9 vaccination in the following cohorts: girls and boys aged 9 to 14 years receiving 2 doses at a 6-month or 12-month interval (+/- 1-month); girls aged 9 to 14 years receiving 3 doses (at 0, 2, 6 months); and women aged 16 to 26 years receiving 3 doses (at 0, 2, 6 months).
Maltese: Il-Protokoll 010 kejjel ir-risponsi ta' antikorpi għal HPV għad-9 tipi ta' HPV wara tilqim b'Gardasil 9 fil-koorti li ġejjin: bniet u subien b'età minn 9 snin sa 14-il sena li rċivew 2 dożi b'intervall ta' 6 xhur jew 12-il xahar (+/-xahar); bniet b'età minn 9 snin sa 14-il sena li rċivew 3 dożi (fix-xhur 0, 2, 6); u nisa b'età minn 16 sa 26 sena li rċivew 3 dożi (fix-xhur 0, 2, 6).
English: The efficacy of L1 VLP vaccines is thought to be mediated by the development of a humoral immune response.
Maltese: L-effikaċja tal-vaċċini VLP L1 hija maħsuba li hi medjata mill-iżvilupp ta' rispons umorali immuni.
English: The efficacy and long-term effectiveness of qHPV vaccine against HPV 6-, 11-, 16-, and 18-related disease endpoints have been demonstrated in clinical studies in the PPE (Per Protocol Efficacy) population.
Maltese: L-effikaċja u l-effikaċja fit-tul tal-vaċċin qHPV kontra l-iskopijiet finali ta' mard marbut ma' HPV 6, 11, 16, u 18 intwerew fi studji kliniċi fil-popolazzjoni PPE (Per Protocol Efficacy, Effikaċja Skont ilProtokoll).
English: {MM/YYYY}
Maltese: L-użu ma' tilqim ieħor
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery.
Maltese: Dan jista' jiġri flimkien ma' diversi sinjali newroloġiċi bħal disturb temporanju fil-vista, paresteżija u ċaqliq toniku-kloniku tar-riġlejn u d-dirgħajn waqt l-irkupru.