FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: 2L1 proteina fis-sura ta' partikuli qishom virus prodotti fiċ-ċelluli tal-ħmira (Saccharomyces cerevisiae CANADE 3C-5 (Speċi 1895)) minn teknoloġija DNA rikombinanti.
English: 9- to 15-Year-Old Boys
Maltese: Subien bejn 9 u 15-il sena
English: Musculoskeletal and Connective Tissue Disorders
Maltese: Disturbi muskolu-skelettriċi u tat-tessuti konnettivi
English: Gardasil will not protect against every type of Human Papillomavirus.
Maltese: Gardasil mhux ser jipproteġi kontra kull tip ta' Papillomavirus Uman.
English: Efficacy was based on reductions in HPV 31-related CIN 2/3 or AIS Efficacy was based on reductions in HPV 31-, 33-, 52-, and 58-related CIN 2/3 or AIS Includes assay-identified non-vaccine HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59.
Maltese: L-effikaċja kienet ibbażata fuq tnaqqis f'CIN 2/3 jew AIS relatati ma' HPV 31 L-effikaċja kienet ibbażata fuq tnaqqis f'CIN 2/3 jew AIS relatati ma' HPV 31-, 33-, 52-, u 58 ║ Tinkludi tipi ta' HPV mhux vaċċin identifikati mill-assaġġ 31, 33, 35, 39, 45, 51, 52, 56, 58, u 59.
English: The immunogenicity of Gardasil was assessed in 20,132 (Gardasil n = 10,723; placebo n = 9,409) girls and women 9 to 26 years of age, 5,417 (Gardasil n = 3,109; placebo n = 2,308) boys and men 9 to 26 years of age and 3,819 women 24 to 45 years of age (Gardasil n = 1,911, placebo n = 1,908).
Maltese: L-immunoġeniċità ta' Gardasil kienet evalwata f'20,132 tifla u mara (Gardasil n = 10,723; plaċebo n = 9,409) ta' bejn id-9 u s-26 sena, 5,417-il tifel u raġel (Gardasil n = 3,109; plaċebo n = 2,308) ta' bejn id-9 u s-26 sena u 3,819-il mara ta' bejn l-24 u l-45 sena (Gardasil n = 1,911,, plaċebo n = 1,908).
English: EU/1/06/357/003 EU/1/06/357/004 EU/1/06/357/005 EU/1/06/357/006 EU/1/06/357/007 EU/1/06/357/008 EU/1/06/357/019 EU/1/06/357/020 EU/1/06/357/021
Maltese: EU/1/06/357/005 EU/1/06/357/006 EU/1/06/357/007 EU/1/06/357/008 EU/1/06/357/019 EU/1/06/357/020
English: Table 5: Efficacy of Gardasil against external genital lesions in the PPE* population of 16-26 year old men
Maltese: L-effikaċja ta' Gardasil kontra leżjonijiet ġenitali esterni fil-popolazzjoni PPE* ta' rġiel b'età minn 16-26 sena
English: These methods of administration are not recommended (see section 6.6).
Maltese: Dawn il-metodi ta' amministrazzjoni mhumiex rakkomandati (ara sezzjoni 6.6).
English: Not known Idiopathic thrombocytopenic purpura*, lymphadenopathy*
Maltese: Purpura tromboċitopenika idjopatika*,
English: In a subset of 598 men (GARDASIL = 299; placebo = 299) in Protocol 020 who self-identified as having sex with men (MSM) efficacy against anal intraepithelial neoplasia (AIN grades 1/2/3) and anal cancer, and intra-anal persistent infection was evaluated.
Maltese: F'sottosett ta' 598 raġel (GARDASIL = 299; plaċebo = 299) f'Protokoll 020 li kienu ammettew li jkollhom rapporti sesswali mal-irġiel (MSM) kienet evalwata l-effikaċja għal kontra neoplasja tal intraepitilju anali (Gradi AIN 1/2/3) u kanċer fl-anus u infezzjoni persistenti intra-anali.
English: The individuals who were monitored using VRC-aided surveillance included 10,088 individuals (6,995 females 9 to 45 years of age and 3,093 males 9 to 26 years of age at enrolment) who received Gardasil and 7,995 individuals (5,692 females and 2,303 males) who received placebo.
Maltese: 10,088 individwu (6,995 mara, ta' età bejn 9 u 45 sena, u 3,093 raġel ta' età bejn 9 u 26 sena fiż-żmien tar-reġistrazzjoni) li rċivew Gardasil u 7,995 individwu (5,692 mara u 2,303 irġiel)li rċevew ilplaċebo.
English: Placebo % Efficacy at 2 years
Maltese: Plaċebo % Effikaċja f'sena 2
English: In the HPV naïve population (naïve to 14 common HPV types and had a negative Pap test at Day 1), Gardasil reduced the proportion of women who experienced a definitive cervical therapy procedure (Loop Electro-Excision Procedure or Cold-Knife Conization) by 41.9% (95% CI: 27.7, 53.5) at end of study.
Maltese: Fil-popolazzjoni naïve għall-HPV(naïve għal 14-il tip ta' HPV komuni u li kellhom test Pap negattiv f'Jum 1), Gardasil naqqas il-proporzjon ta' nisa li esperjenzaw, proċedura ta' terapija ċervikali definittiva (Loop Electro-Excision Procedure jew Cold-Knife Conization) b'41.9% (95% CI: 27.7,
English: Overall, 67% of individuals were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Maltese: B'mod ġenerali, 67% tal-individwi kienu naïve (negattivi u seronegattivi għal PCR) għall-4 tipi ta' HPV kollha fir-reġistrazzjoni.
English: Among 15,706 individuals who received Gardasil and 13,617 individuals who received placebo, there were 39 cases of non-specific arthritis/arthropathy reported, 24 in the Gardasil group and 15 in the placebo group.
Maltese: Fost it-15,706 individwi li rċivew Gardasil u l-13,617-il individwu li rċivew il-plaċebo, kien hemm 39 każ ta' artrite/artropatija mhux speċifika li kienu rrappurtati, 24 fil-grupp ta' Gardasil u 15 fil-grupp tal-plaċebo.
English: In the FAS population, the corresponding reduction was 45.7% (95% CI: 29.0, 58.7) and 38.1% (95% CI: 19.4,
Maltese: Fil-popolazzjoni FAS, it-tnaqqis li jaqbel ma' dan kien ta' 45.7% (95% CI: 29.0, 58.7) u 38.1% (95% CI: 19.4, 52.6).
English: Nine cases (0.06%) of urticaria were reported in the Gardasil group and 20 cases (0.15%) were seen in the adjuvant-containing placebo group.
Maltese: Disa' każijiet (0.06%) ta' urtikarja kienu rrappurtati fil-grupp ta' Gardasil u 20 każ (0.15%) kienu osservati fil-grupp li kien qed jingħata s-sustanza li kien fiha l-plaċebo.
English: An academic study documenting safety and immunogenicity of Gardasil has been performed in 126 HIV infected subjects aged from 7-12 years (of which 96 received Gardasil).
Maltese: Sar studju akkademiku li ddokumenta s-sigurtà u l-immunoġeniċità ta' Gardasil f'126 pazjent infettati bl-HIV li kellhom minn 7 snin sa 12-il sena (li minnhom 96 ħadu Gardasil).
English: Gardasil is available in packs of 1, 10 or 20 vials.
Maltese: Gardasil hu disponibbli f'pakketti ta' 1, 10 jew 20 kunjett.
English: Gardasil 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 jista' jingħata fl-istess ħin ma' vaċċin booster kombinat li fih difterja (d) u tetnu (T) b'jew pertussi [aċellulari, komponent] (ap) u/jew poljomajelite [inattivat] (IPV) (vaċċini dTap, dT-IPV, TdaPdTap-IPV) mingħajr ebda interferenza sinifikanti b'rispons ta' antikorp għal kwalunkwe komponent ta' vaċċin jew ieħor.
English: Number of cases Number of individuals*
Maltese: Numru ta' individwi*
English: 0.5 ml suspension in a vial (glass) with stopper (FluroTec-coated or Teflon-coated chlorobutyl elastomer) and flip-off plastic cap (aluminium crimp band) in a pack size of 1, 10 or 20.
Maltese: Suspensjoni ta' 0.5 ml f'kunjett (ħġieġ) b'tapp (miksi bil-FluroTec jew Teflon miksi bil-chlorobutyl elastomer) u għatu tal-plastik flip-off (strixxa crimp ta' l-aluminju) f'pakkett ta' 1, 10 jew 20.
English: Alternatively, Gardasil can be administered according to a 3-dose (0.5 ml at 0, 2, 6 months) schedule.
Maltese: B'mod alternattiv, Gardasil jista' jingħata skont skeda ta' 3 dożi (0.5 ml fix-xhur 0, 2 u 6).
English: Gardasil is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18.
Maltese: Gardasil huwa vaċċin mhux infettuż, rikombinanti, kwadrivalenti, adjuvanted ippreparat minn partikuli qishom virus-like particles (VLPs) ippurifikati ħafna tal-proteina maġġuri kapsida L1 tat-tipi ta' HPV 6, 11, 16 u 18.
English: How to store Gardasil
Maltese: X'fih Gardasil
English: Afterwards, the GMTs declined through Month 24 - 48 and then generally stabilized.
Maltese: GMTs naqsu minn Xahar 24 - 48 imbagħad b'mod ġenerali stabilizzaw.
English: Clinical Trials
Maltese: Studji Kliniċi
English: Table 8: Long-term immunogenicity data (per-protocol population) based on percentage of seropositive subjects as measured by cLIA and IgG LIA (Protocol 018) at 10 years, in girls and boys 9-15 years of age cLIA
Maltese: Tabella 8: Dejta ta' immunoġeniċità fit-tul (popolazzjoni skont il-protokoll) imsejsa fuq il-perċentwal ta' individwi seropożittivi kif imkejjel b'cLIA u IgG LIA (Protokoll 018) fl-10 sena, f'subien u bniet b'età minn 9-15-il sena cLIA
English: Cervical Intraepithelial Neoplasia (CIN) Grade 2/3 (moderate to high-grade dysplasia) and adenocarcinoma in situ (AIS) were used in the clinical trials as a surrogate marker for cervical cancer.
Maltese: In-Neoplasja Intraepiteljali Ċervikali (CIN) ta' Grad 2/3 (displasja moderata sa grad għoli) u adenokarċinoma in situ (AIS) intużaw fi provi kliniċi bħala indikazzjoni sostituttiva għall-kanċer ċervikali.
English: For adjuvant, see section 2.
Maltese: Għal sustanzi mhux attivi, ara sezzjoni 2.
English: Efficacy in women 24 through 45 years
Maltese: Effikaċja f'nisa b'età minn 24 sa 45 sena
English: The efficacy of Gardasil against CIN (any grade) and CIN 2/3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Maltese: L-effikaċja ta' Gardasil kontra CIN (kull grad) u CIN 2/3 jew AIS ikkawżati minn 10 tipi ta' HPV mhux vaċċin (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) strutturalment relatati ma' HPV 16 jew ma' HPV 18, ġiet evalwata fid-database kombinata ta' l-effikaċja ta' Fażi
English: Gardasil, suspension for injection:
Maltese: Gardasil, suspensjoni għall-injezzjoni:
English: The impact of Gardasil on rates of Definitive Cervical Therapy Procedures regardless of causal HPV types was evaluated in 18,150 individuals enrolled in Protocol 007, Protocols 013 and 015.
Maltese: L-impatt ta' Gardasil fuq ir-rati ta' Proċeduri ta' Terapija Ċervikali Definittivi irrispettivament mit-tipi ta' HPV kawżali kien evalwat fi 18,150 individwu reġistrati fil-Protokoll 007, Protokolli 013 u 015.
English: In the ITT population the corresponding reduction was 23.9% (95% CI: 15.2, 31.7).
Maltese: ITT, it-tnaqqis korrespondenti kien 23.9% (95% CI: 15.
English: Gardasil, suspension for injection.
Maltese: Gardasil, suspensjoni għall-injezzjoni.
English: The efficacy of GARDASIL against HPV 6-, 11-, 16-, 18-related AIN 2/3 and HPV 16- or 18-related AIN 2/3, in the MSM substudy, was 54.2% (95% CI: 18.0, 75.3; 18/275 versus 39/276) and 57.5% (95% CI: -1.8, 83.9; 8/275 versus 19/276 cases), respectively.
Maltese: AIN ta' gradi 2/3 marbuta ma' HPV 6, 11, 16, jew 18, fissottostudju MSM, kienet ta' 54.2% (95% CI: 18.0, 75.3; 18/275 kontra 39/276) u 57.5% (95% CI:1.8, 83.9; 8/275 kontra 19/276 każijiet), rispettivament.
English: There were no treatmentrelated effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Maltese: Ma kien hemm l-ebda effetti marbuta malkura fuq sinjali ta' l-iżvilupp, imġiba, prestazzjoni riproduttiva, jew il-fertilità tal-frieħ.
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); dizziness, 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 b'vaċċini oħra, l-effetti sekondarji li ġew irrapportati 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); sturdament, rimettar, uġigħ fil-ġogi, uġigħ filmuskoli, għeja mhux tas-soltu jew dgħufija, tkexkix ta' bard, tħossok ma tiflaħx b'mod ġenerali, ikollok fsada jew titbenġel b'mod aktar faċli mis-soltu, u infezzjoni fil-ġilda fil-post tal-injezzjoni.
English: Gardasil is available in packs of 1, 10 or 20 pre-filled syringes.
Maltese: Gardasil hu disponibbli f'pakketti ta' 1, 10 jew 20 siringa mimlija għal-lest.
English: Breast-feeding
Maltese: Fil-popolazzjoni
English: HPV 16/18related AIS
Maltese: relatata ma' HPV 16/18
English: The most common adverse reactions observed were injection-site adverse reactions (77.1% of vaccinees within 5 days following any vaccination visit) and headache (16.6% of the vaccinees).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni li ġew osservati kienu reazzjonijiet avversi fis-sit tal-injezzjoni (77.1% tal-persuni mlaqqma fi żmien 5 ijiem minn kwalunkwe vista tat-tilqim) u uġigħ ta' ras (16.6%
English: HIV infected subjects
Maltese: Individwi infettati bl-HIV
English: The efficacy of GARDASIL against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
Maltese: L-effikaċja ta' GARDASIL kontra felul ġenitali estern ikkawżat minn HPV 6, 11, 16, 18 kienet ta' 68.1% (95% CI: 48.8, 79.3).
English: Ten years after vaccination, 79%, 85%, 94%, and 36% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 86%, 79%, 100% and 83% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Maltese: Għaxar snin wara t-tilqim, 79%, 85%, 94% u 36% kienu seropożittivi kontra HPV 6, kontra HPV 11, kontra HPV 16 u kontra HPV 18 f'cLIA, rispettivament, u 86%, 79%, 100% u 83% kienu seropożittivi kontra HPV 6, kontra HPV 11, kontra HPV 16 u kontra HPV 18 f'IgG LIA, rispettivament.
English: Table 6 compares the 1 month Postdose 3 anti-HPV 6, 11, 16, and 18 GMTs in 9- to 15 year-old girls with those in 16- to 26-year old women.
Maltese: Tabella 6 tqabbel l-anti-HPV 6, 11, 16 u 18 GMTs xahar Wara d-Doża 3 fi bniet ta' bejn 9 u 15-il sena ma' dawk f'nisa ta' età bejn 16 u 26 sena.
English: In the long-term extension study of Protocol 015, 2,536 women 16-23 years old during vaccination with Gardasil in the base study were followed.
Maltese: Fl-istudju ta' estensjoni fit-tul tal-Protokoll 015, ġew segwiti 2,536 mara li kellhom minn 16-23 sena meta tlaqqmu b'Gardasil fl-istudju bażi.
English: Efficacy results are presented for the combined analysis of study protocols.
Maltese: Fl-aħħar tal-istudju u fil-protokolli kombinati,
English: Fourteen years after vaccination, 91%, 91%, 98% and 52% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 98%, 98%, 100% and 94% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Maltese: Erbatax-il sena wara t-tilqim, 91%, 91%, 98% u 52% kienu seropożittivi kontra HPV 6, kontra HPV 11, kontra HPV 16 u kontra HPV 18 f'cLIA, rispettivament, u 98%, 98%, 100% u 94% kienu seropożittivi kontra HPV 6, kontra HPV 11, kontra HPV 16 u kontra HPV 18 f'IgG LIA, rispettivament.
English: The efficacy of Gardasil against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 41.6% (95% CI: 24.3, 55.2).
Maltese: L-effikaċja ta' Gardasil kontra l-inċidenza kombinata ta' infezzjoni persistenti relatata ma' HPV 16 jew 18, felul ġenitali, leżjonijiet vulvari u vaġinali, CIN ta' kwalunkwe grad, AIS, u kanċers ċervikali kienet ta' 41.6 % (95% CI: 24.3, 55.2).
English: Table 2: Analysis of efficacy of Gardasil against high grade cervical lesions in the PPE population Gardasil
Maltese: Tabella 2: Analiżi ta' l-effikaċja ta' Gardasil kontra leżjonijiet ċervikali ta' grad għoli fil-popolazzjoni
English: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon France
Maltese: 162 avenue Jean Jaurès
English: Individuals 9 to and including 13 years of age Gardasil can be administered according to a 2-dose schedule (0.5 ml at 0, 6 months) (see section 5.1).
Maltese: Gardasil jista' jingħata skont skeda ta' 2 dożi (0.5 ml fix-xhur 0 u 6) (ara sezzjoni 5.1).
English: At end of study analysis for anal lesions in the MSM population (median duration of follow-up was 2.15 years), the preventive effect against HPV 6-, 11-, 16-, 18-related AIN 2/3 was 74.9% (95 % CI: 8.8, 95.4; 3/194 versus 13/208) and against HPV 16- or 18-related AIN 2/3 86.6% (95 % CI: 0.0, 99.7; 1/194 versus 8/208).
Maltese: Fl-analiżi tat-tmiem tal-istudju għal-leżjonijiet anali fil-popolazzjoni MSM (medja ta' kemm damu jiġu segwiti kienet ta' 2.15 il-sena), l-effett preventiv kontra AIN 2/3 marbut mal-HPV 6, 11, 16, 18 kien 74.9% (95% CI 8.8, 95.4; 3/194 kontra 13/208) u kontra AIN 2/3 marbut mal-HPV 16 jew 18 kien 86.6% (95% CI 0.0, 99.7 ; 1/194 kontra 8/208).
English: Efficacy in men 16 through 26 years
Maltese: Irġiel bejn 16 u 26 sena n
English: The data on Gardasil administered during pregnancy did not indicate any safety signal.
Maltese: L-informazzjoni fuq Gardasil mogħti waqt it-tqala ma tindikax l-ebda sinjal tas-sigurtà.
English: In all populations (women 9 - 45 years, men 9 - 26 years), peak anti-HPV 6, anti-HPV 11, antiHPV 16, and anti-HPV 18 GMTs cLIA were observed at Month 7.
Maltese: Fil-popolazzjonijiet kollha (nisa minn 9 - 45 sena, irġiel minn 9 - 26 sena), l-ogħla GMTs cLIA kontra HPV 6, kontra HPV 11, kontra HPV 16, u kontra HPV 18 kienu osservati f'Xahar 7.
English: In 7 clinical trials (6 placebo-controlled), individuals were administered Gardasil or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
Maltese: F'7 provi kliniċi (6 ikkontrollati bil-plaċebo), l-individwi ngħataw Gardasil jew il-plaċebo fil-jum tarreġistrazzjoni u madwar xahrejn u 6 xhur wara dan.
English: CIN 3 and AIS have been accepted as immediate precursors of invasive cervical cancer.
Maltese: CIN 3 u AIS ġew aċċettati bħala prekursuri immedjati ta' kanċer ċervikali invażiv.
English: In the HPV naïve population (naïve to 14 common HPV types), Gardasil reduced the proportion of men who had a biopsy by 54.2% (95% CI: 28.3, 71.4) and who were treated by 47.7% (95% CI: 18.4, 67.1) at end of study.
Maltese: Fil-popolazzjoni li qatt ma kellha HPV qabel (qatt ma kellha xi wieħed mill-14-il tip komuni ta' HPV), Gardasil naqqas il-proporzjon ta' rġiel li kellhom biopsija b'54.2% (95% CI: 28.3, 71.4) u dawk li ġew ikkurati b'47.7% (95% CI: 18.4, 67.1) fi tmiem l-istudju.
English: (95% CI: 67.2, 100) and 100% (95% CI: 55.4, 100), respectively,
Maltese: 7% (95% CI: 67.5, 93.7).
English: Date of first authorisation: 20 September 2006 Date of latest renewal: 27 July 2011
Maltese: Data tal-aħħar tiġdid: 27 ta' Lulju 2011
English: B. Tabulated summary of adverse reactions
Maltese: Tabella 1: Każijiet Avversi
English: In the long-term extension study of Protocol 019, 685 women 24-45 years old during vaccination with Gardasil in the base study were followed.
Maltese: Fl-istudju ta' estensjoni fit-tul tal-Protokoll 019, ġew segwiti 685 mara li kellhom minn 24-45 sena meta tlaqqmu b'Gardasil fl-istudju bażi.
English: Gardasil is a vaccine for use from the age of 9 years for the prevention of: - premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV)
Maltese: Gardasil hu vaċċin biex jintuża mill-età ta' 9 snin għall-prevenzjoni ta': leżjonijiet ġenitali (ċervikali, vulvari u vaġinali) qabel isiru malinni, leżjonijiet anali qabel isiru malinni, kansers ċervikali u kansers anali li l-kawża tagħhom hi marbuta ma' ċerti tipi onkoġeniċi ta' Papillomavirus Uman (HPV) felul ġenitali (condyloma acuminata) li l-kawża tagħhom hija marbuta ma' tipi speċifiċi ta'
English: In the PPE population, no cases of HPV types 6/11 related genital warts, HPV 6/11/16/18 external genital lesions or HPV 6/11/16/18 high grade AIN in MSM were observed through 11.5 years (median follow-up of 9.5 years).
Maltese: Fil-popolazzjoni PPE, ma kienu osservati l-ebda każijiet ta' felul ġenitali marbut mat-tipi 6/11 ta' HPV, feriti ġenitali esterni b'HPV 6/11/16/18 jew grad għoli ta' AIN b'HPV 6/11/16/18 f'MSM sa 11.5 snin (medjan ta' segwitu ta' 9.5 snin).
English: Table 4: Results for CIN 2/3 or AIS in Type-Specific HPV-Naïve Individuals
Maltese: Tabella 4: Riżultati għal CIN 2/3 jew AIS f'Individwi naïve għall-HPV Speċifiku għat-Tip† (riżultati ta' tmiem l-istudju)
English: The CD4% or plasma HIV RNA was not affected by vaccination.
Maltese: Is-CD4% jew l-RNA tal-HIV fil-plażma ma kinux affettwati mit-tilqim.
English: The duration of immunity following a 3-dose series has been observed for up to 14 years post-vaccination.
Maltese: It-tul ta' żmien ta' immunità wara serje ta' 3 dożi ġie osservat sa 14-il sena wara t-tilqim.
English: Immune Responses to Gardasil at 1 month post dose 3
Maltese: Immuni għal Gardasil xahar wara doża 3
English: Women vaccinated with Gardasil at 24-45 years of age in Protocol 019 base study were followed up in an extension study.
Maltese: Nisa mlaqqma b'Gardasil fl-età ta' 24-45 sena fl-istudju bażi tal-Protokoll 019 ġew segwiti fi studju ta' estensjoni.
English: Gardasil can be given with a Hepatitis B vaccine or 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, e.g. the other arm or leg) during the same visit.
Maltese: Gardasil jista' jingħata ma' vaċċin ta' l-Epatite B jew ma' vaċċin booster ikkombinat li fih difterja (d) u tetnu (T) b'jew pertussi [aċellulari, komponent] (ap) u/jew poljomajelite [inattivat] (IPV) (vaċċini dTap, dT-IPV, TdaPdTap-IPV) f'sit differenti ta' l-injezzjoni (parti oħra minn ġismek, eż. id-driegħ lieħor jew ir-riġel l-ieħor) matul l-istess żjara.
English: In the modified ITT population, the benefit of the vaccine with respect to the overall incidence of CIN 2/3 or AIS (caused by any HPV type) and of genital warts was much lower, with a reduction of 18.4% (95% CI: 7.0, 28.4) and 62.5% (95% CI: 54.0, 69.5), respectively, as Gardasil does not impact the course of infections or disease that are present at vaccination onset.
Maltese: Fil-popolazzjoni ITT mibdula, il-benefiċċju tal-vaċċin fir-rigward ta' l-inċidenza globali ta' CIN 2/3 jew AIS (ikkawżata minn kwalunkwe tip ta' HPV) u ta' felul ġenitali kien ferm inqas, bi tnaqqis ta' 18.4% (95% CI: 7.0, 28.4) u 62.5% (95% CI: 54.0, 69.5), rispettivament, minħabba li Gardasil ma għandux impatt fuq il-kors ta' l-infezzjonijiet jew mard li jfeġġu mal-bidu tat-tilqima.
English: In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Gardasil.
Maltese: Fi provi kliniċi, kontraċettivi orali jew kontraċettivi oħrajn (eż. pilloli) ma naqqsux il-protezzjoni miksuba minn Gardasil.
English: (HPV 31/45) (HPV 31/33/45/52/58) 10 non-vaccine HPV Types HPV-16 related types (A9 species) HPV 31 HPV 33 HPV 35 HPV 52 HPV 58 HPV-18 related types (A7 species) HPV 39 HPV 45 HPV 59 A5 species (HPV 51) A6 species (HPV 56)
Maltese: HPV 45 HPV 59 Speċi A5 (HPV 51) Speċi A6 (HPV 56) L-istudji ma kinux mgħammra biex jivvalutaw l-effikaċja kontra marda kkawżata minn tipi ta' HPV individwali.