natgillin/translations-raw huggingface dataset:
The vaccine also produces type-specific antibodies in 9- to 15-year-old children and adolescents.
Nastajanje tipsko specifičnih protiteles povzroči tudi pri 9 do 15 let starih otrocih in
Allergic reactions that may include difficulty breathing, wheezing (bronchospasm), hives and rash have been reported.
Alergijske reakcije, ki lahko vključujejo težko dihanje, sopenje (bronhospazem), koprivnico in izpuščaj; nekatere od teh reakcij so bile hude.
At end of study, individuals enrolled in the two Phase-III studies (Protocol013 and Protocol-015), were followed for up to 4 years (median 3.7 years).
Na koncu študije je bil čas spremljanja oseb, vključenih v dve študiji III. faze (Protokol 013 in Protokol 015), do 4 leta (mediana 3,7 let).
Rarely (less than 1 in 1000 patients): hives (urticaria).
Redki (pri manj kot 1 od 1.000 cepljenih oseb): koprivnica (urtikarija).
Few individuals (0.2%) discontinued due to adverse reactions.
Zaradi neželenih učinkov je bilo iz preskušanj izključenih le nekaj oseb (0,2 %).
Individuals with impaired immune responsiveness, due to either the use of potent immunosuppressive therapy, a genetic defect, or other causes, may not respond to the vaccine.
Pri osebah z imunsko pomanjkljivostjo zaradi agresivnega imunosupresivnega zdravljenja, genetske okvare ali drugih vzrokov odziv na cepljenje morda ne bo dosežen.
For composite endpoints, statistically significant efficacy against disease was demonstrated against HPV types phylogenetically related to HPV 16 (primarily HPV 31) whereas no statistically significant efficacy was observed for HPV types phylogenetically related to HPV 18 (including HPV 45).
Za sestavljene opazovane dogodke so statistično značilno učinkovitost proti bolezni ugotovili za tipe HPV, ki so filogenetsko sorodni HPV 16 (primarno HPV 31), medtem ko za tipe HPV, ki so filogenetsko sorodni HPV 18 (vključno s HPV 45) statistično značilne učinkovitosti niso opazili.
HPV types 6 and 11 are responsible for approximately 90% of
HPV tipa 6 in 11 sta odgovorna za približno 90 % primerov bradavic na spolovilih.
Table 5: Efficacy of Silgard against external genital lesions in the PPE* population of 16-26 year old
Preglednica 5: Učinkovitost cepiva Silgard proti lezijam na zunanjih spolovilih v populaciji PPE* moških, starih od 16 do 26 let
The use of Silgard in adult women should take into consideration the variability of HPV type prevalence in different geographical areas.
Pri uporabi cepiva Silgard pri odraslih ženskah je treba upoštevati variabilnost v razširjenosti tipa HPV
In addition, a subset of vaccinated women who received a challenge dose of Silgard 5 years after the onset of vaccination, exhibited a rapid and strong anamnestic response that exceeded the anti-HPV GMTs observed 1 month Postdose 3.
Razen tega so pri cepljenih ženskah, ki so 5 let po začetku cepljenja prejele obnovitveni odmerek cepiva Silgard opazili hiter in močan anamnestični odziv, ki je presegel srednje geometrijske titre anti HPV, opažene 1 mesec po cepljenju s
However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation.
Vendar pa blažja okužba, kot sta blaga okužba zgornjih dihal ali rahlo zvišana telesna temperatura, ni kontraindikacija za cepljenje.
Immunogenicity was related to age and Month 7 anti-HPV levels were significantly higher in younger individuals.
Imunogenost je bila povezana s starostjo, ravni anti-HPV 7. mesec pa so bile pri mlajših osebah
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali farmacevtom.
At Month 7, in the Per Protocol population, the immune response in girls aged 9-13 years (n = 241) who received 2 doses of Silgard (at 0, 6 months) was non-inferior and numerically higher to the immune response in women aged 16-26 years (n = 246) who received 3 doses of Silgard (at 0, 2,
V 7. mesecu je bil imunski odziv v populaciji per protocol pri deklicah, starih od 9 do 13 let (n = 241), ki so prejele 2 odmerka cepiva Silgard (v 0. in 6. mesecu), neinferioren in je bil številčno večji kot imunski odziv pri ženskah, starih od 16 do 26 let (n = 246), ki so prejele 3 odmerke cepiva Silgard (v 0., 2. in 6. mesecu).
• you or your child developed an allergic reaction after receiving a dose of Silgard.
• če se je pri vas ali vašem otroku po cepljenju z odmerkom cepiva Silgard pojavila alergijska reakcija;
Evidence of an anamnestic response was seen in vaccinated women who were seropositive to relevant HPV type(s) prior to vaccination.
Dokaz anamnestičnega odziva so zasledili pri cepljenih ženskah, ki so bile pred cepljenjem seropozitivne na relevantni tip (relevantne tipe) HPV.
After thorough agitation, it
Ko ga dobro pretresemo, je
Type-specific immunoassays, competitive Luminex-based immunoassay (cLIA), with type-specific standards were used to assess immunogenicity to each vaccine type.
Imunogenost vsakega od vakcinalnih tipov je bila ovrednotena s tipsko specifičnim imunskim testom (competitive Luminex-based immunoassay - cLIA), pri čemer so bili uporabljeni tipsko specifični standardi.
Silgard will not protect against every type of Human Papillomavirus.
Cepivo Silgard ne ščiti pred vsakim tipom humanih papilomavirusov.
The median duration of follow-up for these studies was 4.0, 3.0, 3.0, and 3.0 years for Protocol 005, Protocol 007, Protocol 013, and Protocol 015, respectively.
Mediani čas spremljanja v teh študijah je bil 4,0 leta za Protokol 005, ter 3,0 leta za Protokol 007, Protokol 013 in Protokol 015.
The concomitant administration of Silgard with vaccines other than the ones above has not been studied.
Sočasnega cepljenja s cepivom Silgard in z drugimi cepivi (razen z zgoraj naštetimi) niso raziskali.
The vaccine is therefore not indicated for treatment of cervical cancer, high-grade cervical, vulvar, and vaginal dysplastic lesions or genital warts.
Cepivo torej ni indicirano za zdravljenje raka na materničnem vratu, cervikalnih, vulvarnih in vaginalnih displastičnih sprememb visoke stopnje ali bradavic na spolovilih.
How Silgard is given
Kako se daje cepivo Silgard
- genital warts (condyloma acuminata) causally related to specific HPV types.
- bradavic na spolovilih (koničasti kondilomi), ki so vzročno povezane s specifičnimi tipi HPV.
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.
Kot pri drugih cepivih so tudi pri splošni uporabi tega cepiva poročali o oteklih bezgavkah (vratnih, pazdušnih in dimeljskih), oslabelosti mišic, nenormalnih občutkih, mravljinčenju v rokah, nogah in zgornjem delu telesa ali zmedenosti (Guillain-Barréjev sindrom, akutni diseminirani encefalomielitis), omotici, bruhanju, bolečinah v sklepih, bolečinah v mišicah, nenavadni utrujenosti ali šibkosti, mrzlici, splošnemu slabemu počutju, večjemu nagnjenju h krvavitvam ali modricam ter vnetju kože na mestu
Silgard administered to male rats at the full human dose (120 mcg total protein) had no effects on reproductive performance including fertility, sperm count, and sperm motility, and there were no vaccine-related gross or histomorphologic changes on the testes and no effects on testes weights.
Cepivo Silgard, uporabljeno pri podganjih samcih v polnem odmerku za človeka (skupno 120 mikrogramov beljakovin), ni vplivalo na reproduktivno zmogljivost, vključno s plodnostjo, številom semenčic in gibljivostjo semenčic; ugotovili niso nobenih s cepivom povezanih makroskopskih ali histomorfoloških sprememb mod in nobenih učinkov na maso mod.
Longer term follow-up studies are ongoing to determine whether a booster dose is needed.
Daljše študije, ki bodo pokazale, če je potreben dodaten odmerek,
Efficacy in women 16 through 26 years
Učinkovitost pri ženskah, starih 16 do 26 let
*Number of individuals with at least one follow-up visit after Month 7 **Based on virologic evidence, the first CIN 3 case in a patient chronically infected with HPV 52 is likely to be causally related to HPV 52.
**Na osnovi viroloških dokazov je bil prvi primer CIN 3 pri osebi s kronično okužbo s HPV 52 verjetno vzročno povezan s HPV 52.
In general, the adverse event profile reported with overdose was comparable to recommended single
Profil neželenih dogodkov, o katerih so poročali pri prevelikem odmerjanju, je bil na splošno primerljiv s profilom pri priporočenem enkratnem odmerku cepiva Silgard.
% Efficacy (95%CI)
% učinkovitosti (95 % IZ)
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni naveden v tem navodilu, obvestite zdravnika ali farmacevta.
In the Full Analysis Set (FAS) population, the benefit of the vaccine with respect to the overall incidence of EGL was lower, with a reduction of 59.3% (95% CI: 40.0, 72.9), as Silgard does not impact the course of infections or disease that are present at vaccination onset.
V populaciji celotnega nabora za analizo (FAS) je bila korist cepiva glede celotne incidence lezij na zunanjih spolovilih manjša, z zmanjšanjem za 59,3 % (95 % IZ: 40,0; 72,9), ker cepivo Silgard ne vpliva na potek okužb ali bolezni, ki so prisotne ob začetku cepljenja.
In males, dizziness was not observed at a greater frequency in vaccine recipients than in placebo recipients.
Pri moških omotice med prejemniki cepiva niso opažali pogosteje kot med prejemniki placeba.
Women who were already infected with one or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV
Ženske, ki so pred cepljenjem že bile okužene z enim ali več tipi HPV, ki jih vsebuje cepivo, so bile zaščitene pred klinično boleznijo zaradi preostalih tipov HPV, ki jih vsebuje cepivo.
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
Preglednica 8: Dolgoročni podatki o imunogenosti (populacija per-protokol) na podlagi odstotkov seropozitivnih oseb, izmerjeno s cLIA in IgG LIA (protokol 018) po 10 letih pri deklicah in dečkih, starih od 9 do 15 let cLIA
This vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Pri osebah s trombocitopenijo ali katero koli motnjo strjevanja krvi je potrebna previdnost, saj se po dajanju cepiva v mišico lahko pojavi krvavitev.
The indication is based on the demonstration of efficacy of Silgard in females 16 to 45 years of age and in males 16 to 26 years of age and on the demonstration of immunogenicity of Silgard in 9- to 15-year old children and adolescents.
Indikacija temelji na dokazu učinkovitosti cepiva Silgard pri ženskah, starih 16 do 45 let, in moških, starih 16 do 26 let, ter dokazu imunogenosti cepiva Silgard pri 9 do 15 let starih otrocih in
Silgard will not protect against other diseases that are not caused by Human Papillomavirus.
Cepivo Silgard ne ščiti pred boleznimi, katerih povzročitelji niso humani papilomavirusi.
The efficacy of Silgard 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).
Učinkovitost cepiva Silgard proti CIN (vseh stopenj) in CIN 2/3 ali AIS, povzročenimi z 10 tipi HPV, ki niso v cepivu (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) in so strukturno podobni HPV 16 ali HPV 18 so vrednotili v kombinirani podatkovni bazi učinkovitosti študije III. faze (N = 17.599) po medianem času spremljanja 3,7 leta (na koncu študije).
Administration of Silgard should be postponed in individuals suffering from an acute severe febrile illness.
Cepljenje s cepivom Silgard je treba odložiti pri osebah, ki imajo hujšo akutno bolezen z zvišano telesno temperaturo.
The immunogenicity of Silgard was assessed in 20,132 (Silgard n = 10,723; placebo n = 9,409) girls and women 9 to 26 years of age, 5,417 (Silgard 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 (Silgard n = 1,911, placebo n = 1,908).
Imunogenost cepiva Silgard je bila ocenjena pri 20.132 (Silgard n = 10.723; placebo n = 9.409) deklicah in ženskah, starih 9 do 26 let, 5.417 (Silgard n = 3.109; placebo n = 2.308) dečkih in moških, starih 9 do 26 let, in 3.819 ženskah, starih 24 do 45 let (Silgard n = 1.911, placebo n = 1.908).
Three clinical studies (Protocols 016, 018 and 020) were used to compare the immunogenicity of Silgard in 9- to 15-year-old boys to 16- to 26-year-old men.
Tri klinične študije (Protokoli 016, 018 in 020) so bile uporabljene za primerjavo imunogenosti cepiva Silgard pri dečkih, starih od 9 do 15 let, in pri moških, starih od 16 do 26 let.
The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination.
Pri odločitvi za cepljenje posamezne osebe je treba upoštevati tveganje za predhodno izpostavitev
It is also not intended to prevent progression of other established HPV-related lesions.
Cepivo prav tako ni namenjeno za preprečevanje napredovanja drugih sprememb, dokazano povezanih s HPV.
In the vaccine group, 97.4 to 99.9% became seropositive to all vaccine serotypes by 1 month Postdose 3.
V cepljeni skupini je od 97,4 do 99,9 % oseb postalo v 1 mesecu po 3. odmerku seropozitivnih za vse serotipe v cepivu.
Table 4: Results for CIN 2/3 or AIS in Type-Specific HPV-Naïve Individuals
Preglednica 4: Rezultati za CIN 2/3 ali AIS pri osebah, ki še niso bile okužene s tipsko specifičnimi
A clinical study (Protocol 016) compared the immunogenicity of Silgard in 10- to 15-year-old girls to those in 16- to 23-year-old women.
Klinična študija (Protokol 016) je primerjala imunogenost cepiva Silgard pri 10- do 15-letnih deklicah z imunogenostjo pri 16- do 23-letnih ženskah.
The full recommended dose of the vaccine should be used.
Dati morate celoten priporočeni odmerek cepiva.
Sodium chloride, L-histidine, polysorbate 80, sodium borate and water for injections.
natrijev klorid, L-histidin, polisorbat 80, natrijev borat in voda za injekcije.
During clinical trials, dizziness was observed as a common adverse reaction in females.
Med kliničnimi preskušanji so kot pogost neželeni učinek pri ženskah opažali omotico.
Silgard will be given as an injection through the skin into the muscle (preferably the muscle of the
Oseba, ki bo cepljena, bo cepivo Silgard prejela v obliki injekcije skozi kožo v mišico (po možnosti v
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 Silgard and 7,995 individuals (5,692 females and 2,303 males) who received placebo.
S pomočjo kartončkov za poročanje je bilo nadziranih 10.088 oseb, ki so prejele cepivo Silgard (6.995 žensk, ki so bile ob vključitvi stare 9 do 45 let in 3.093 moških, ki so bili ob vključitvi stari 9 do 26 let), ter 7.995 oseb (5.692 žensk in 2.303 moških), ki so prejele placebo.
Table 1 presents vaccine-related adverse reactions which were observed among recipients of Silgard at a frequency of at least 1.0% and also at a greater frequency than observed among placebo recipients.
V preglednici I so navedeni s cepivom povezani neželeni učinki, opaženi pri osebah, ki so prejele cepivo Silgard, katerih pogostnost je bila vsaj 1,0 % in tudi večja od pogostnosti pri osebah, ki so prejele placebo.
There were no treatment related effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Pri mladičih niso opazili učinkov cepiva na razvoj, obnašanje, sposobnost za razmnoževanje ali plodnost.
Bridging the Efficacy of Silgard from Women to Girls
Primerjava učinkovitosti cepiva Silgard pri ženskah in deklicah
In a clinical trial of 843 healthy adolescent males and females 11-17 years of age, administration of the first dose of Silgard concomitantly with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine showed that there was more injection-site swelling and headache reported following concomitant administration.
V kliničnem preskušanju pri 843 zdravih mladostnikih in mladostnicah, starih 11-17 let, se je pri sočasnem cepljenju s prvim odmerkom cepiva Silgard in kombiniranim obnovitvenim odmerkom cepiva proti davici, tetanusu, oslovskemu kašlju [acelularno, komponentno cepivo] in otroški ohromelosti [inaktivirano cepivo] pokazalo, da so pri sočasnem cepljenju poročali o več primerih otekanja na mestu cepljenja in glavobola.
Total IgG Luminex Immunoassay (IgG LIA) was used to assess the persistence of immune response in addition to cLIA.
Za oceno persistence imunskega odziva so poleg cLIA uporabili celokupni IgG Luminex imunski preizkus (IgG LIA - Total IgG Luminex Immunoassay).
Single-dose and repeated-dose toxicity and local tolerance studies revealed no special hazards to humans.
Študije toksičnosti pri enkratnem in ponavljajočih se odmerkih ter tolerančne študije ne kažejo
The term "premalignant anal lesions" in section 4.1 corresponds to high-grade anal intraepithelial neoplasia (AIN 2/3).
Izraz "predrakave analne lezije" v poglavju 4.1 predstavlja intraepitelijsko neoplazijo visoke stopnje na anusu (AIN 2/3).
The impact of Silgard against the overall risk for cervical, HPV disease (i.e., disease caused by any HPV type) was evaluated starting 30 days after the first dose in 17,599 individuals enrolled in the two phase III efficacy trials (Protocols 013 and 015).
Vpliv cepiva Silgard proti celotnemu tveganju za bolezen materničnega vratu zaradi HPV (to je proti boleznim zaradi katerega koli tipa HPV) so začeli vrednotiti 30 dni po aplikaciji prvega odmerka pri 17.599 osebah, vključenih v dve preskušanji učinkovitosti III. faze (protokola 013 in 015).
• If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient's size and weight.
• Če sta v škatli 2 različno dolgi igli, izberite tisto, ki je najprimernejša za bolnika, glede na
The impact of Silgard 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.
Vpliv cepiva Silgard na delež defenitivnih terapevtskih posegov na materničnem vratu, ne glede na vzročni tip HPV, je bil ovrednoten pri 18.150 osebah, vključenih v protokol 007, protokol 013 in protokol 015.
Fainting, sometimes accompanied by shaking or stiffening, has been reported.
Omedlevica, včasih s spremljajočim tresenjem ali odrevenelostjo.
Individuals 14 years of age and older Silgard should be administered according to a 3-dose (0.5 ml at 0, 2, 6 months) schedule.
Posamezniki, stari 14 let ali več Cepivo Silgard je treba aplicirati v skladu s 3-odmerno shemo cepljenja (0,5 ml v 0., 2. in 6. mesecu).
All three doses should be given within
Oseba mora vse tri odmerke cepiva prejeti v
AntiHBs geometric mean antibody titres were lower on co-administration, but the clinical significance of
Geometrijski srednji titri protiteles anti-HB so bili pri sočasni uporabi nižji, vendar pa klinični pomen te ugotovitve ni znan.
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.
0,5 ml suspenzije v viali (steklo) z zamaškom (s FluroTec-om ali teflonom obloženi klorobutilni elastomer) in plastičnim pokrovčkom (z aluminijastim obročkom) v pakiranju po 1, 10 ali 20.
There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in Silgard and placebo treated individuals.
Razlike v vrsti nenormalnosti ali deležu nosečnosti z neželenim izidom pri osebah, cepljenih s cepivom Silgard, in pri osebah, ki so dobile placebo, niso bile značilne.
The impact of Silgard against the overall risk for external genital lesions was evaluated after the first dose in 2,545 individuals enrolled in the Phase III efficacy trial (Protocol 020).
Vpliv cepiva Silgard proti celotnemu tveganju za lezije na zunanjem spolovilu so ocenili po prvem odmerku pri 2.545 osebah, vključenih v preskušanje učinkovitosti faze III (Protokol 020).
The impact of Silgard on rates of biopsy and treatment of EGL regardless of causal HPV types was evaluated in 2,545 individuals enrolled in Protocol 020.
Vpliv cepiva Silgard na delež biopsij in zdravljenja lezij na zunanjih spolovilih ne glede na vzročni tip HPV so ocenili pri 2.545 osebah, vključenih v Protokol 020.
Table 1: Adverse Events Following Administration of Silgard from Clinical Trials and Post-Marketing
Preglednica 1: Neželeni učinki po uporabi cepiva Silgard med kliničnimi preskušanji in spremljanjem
Like all vaccines and medicines, Silgard can cause side effects, although not everybody gets them.
Kot vsa cepiva ima lahko tudi cepivo Silgard neželene učinke, ki pa se ne pojavijo pri vseh osebah.
In the vaccine group, 99.1 to 100% became seropositive to all vaccine serotypes by 1 month Postdose 3.
V skupini, ki je dobila cepivo, jih je v enem mesecu po 3. odmerku 99,1 do 100 % postalo seropozitivnih na vse serotipe cepiva.
Protection Against the Overall Burden of HPV disease in 16- Through 26-Year-Old Men
Zaščita pred celotnim bremenom bolezni zaradi HPV pri moških, starih od 16 do 26 let
Prior to agitation, Silgard may appear as a clear liquid with a white precipitate.
• Pred pretresanjem ima lahko cepivo Silgard videz bistre tekočine z belo oborino.
The term "premalignant genital lesions" in section 4.1 corresponds to high-grade cervical intraepithelial neoplasia (CIN 2/3), high-grade vulvar intraepithelial neoplasia (VIN 2/3) and highgrade vaginal intraepithelial neoplasia (VaIN 2/3).
Izraz "predrakave genitalne lezije" v poglavju 4.1 predstavlja cervikalno intraepitelijsko neoplazijo visoke stopnje (CIN 2/3), intraepitelijsko neoplazijo visoke stopnje na vulvi (VIN 2/3) in intraepitelijsko neoplazijo visoke stopnje na nožnici (VaIN 2/3).
• Silgard is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.
• Silgard je na voljo v napolnjeni injekcijski brizgi, pripravljeni za intramuskularno (i.m.)
Silgard is available in packs of 1, 10 or 20 vials.
Cepivo Silgard je na voljo v pakiranjih z 1, 10 ali 20 vialami.
Nine cases (0.06%) of urticaria were reported in the Silgard group and 20 cases (0.15%) were seen in the adjuvant-containing placebo group.
V skupini, ki je prejemala cepivo Silgard so poročali o devetih primerih (0,06 %) urtikarije, v skupini, ki je prejemala placebo, ki je vseboval adjuvans, pa o 20-ih primerih (0,15 %).
In the FAS population, the corresponding reduction was 45.7% (95% CI: 29.0, 58.7) and 38.1% (95% CI: 19.4,
V populaciji FAS sta bili ustrezni zmanjšanji 45,7 % (95 % IZ: 29,0; 58,7) in 38,1 % (95 % IZ: 19,4; 52,6).
Table 3: Efficacy of Silgard in high grade cervical lesions in the modified ITT-population including women regardless of baseline HPV status
Preglednica 3: Učinkovitost cepiva Silgard proti spremembam na materničnem vratu visoke stopnje v modificirani ITT populaciji žensk ne glede na začetni HPV status
In all clinical trials, individuals who had received immunoglobulin or blood-derived products during the 6 months prior to the first vaccine dose were excluded.
Posamezniki, ki so do 6 mesecev pred cepljenjem s prvim odmerkom cepiva prejeli imunoglobuline ali zdravila iz krvi, so bili izključeni iz vseh kliničnih preskušanj.