natgillin/translations-raw huggingface dataset:
In clinical studies, 57.5% of women (age 16 to 26 years) who received Gardasil used hormonal contraceptives.
V kliničnih študijah je 57, 5% žensk (starih od 16 do 26 let), ki so prejele cepivo Gardasil, uporabljalo hormonske kontraceptive.
During the clinical development program, 3,315 women (vaccine = 1,657 vs. placebo = 1,658) reported at least one pregnancy.
Med programom kliničnega razvoja so pri 3. 315 ženskah (cepivo = 1. 657, placebo = 1. 658) poročali o vsaj eni nosečnosti.
There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in Gardasil and placebo treated subjects.
Razlike v vrsti nenormalnosti ali deležu nosečnosti z neželenim izidom pri osebah, zdravljenih s cepivom Gardasil, in pri osebah, zdravljenih s placebom, niso bile značilne.
Vaccination should, therefore, be postponed until completion of pregnancy.
Zato je treba cepljenje odložiti do konca nosečnosti.
In breastfeeding mothers given Gardasil or placebo during the vaccination period of the clinical trials the rates of adverse reactions in the mother and the breastfed infant were comparable between the vaccination and the placebo groups.
Med potekom cepljenja v kliničnih preskušanjih, v katerih so doječe matere prejele cepivo Gardasil ali placebo, je bil odstotek neželenih učinkov pri materi in dojenem otroku v skupini, ki je prejela cepivo, primerljiv z odstotkom v skupini, ki je prejela placebo.
Therefore Gardasil can be given to breastfeeding women.
Doječe matere se zato lahko cepi s cepivom Gardasil.
4 In 5 clinical trials (4 placebo-controlled), subjects were administered Gardasil or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
V 5 kliničnih preskušanjih (4 nadzorovanih s placebom) so osebe cepivo Gardasil ali placebo prejele na dan vključitve in nato približno čez 2 in 6 mesecev.
Few subjects (0.2%) discontinued due to adverse reactions.
Zaradi neželenih učinkov je bilo iz preskušanj izključenih le nekaj oseb (0, 2%).
Safety was evaluated in either the entire study population (4 studies) or in a predefined subset (one study) of the study population using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Gardasil or placebo.
Varnost so vrednotili bodisi pri celotni populaciji, vključeni v študijo (4 študije), bodisi pri vnaprej določeni podskupini (1 študija) v študijo vključene populacije, na osnovi 14- dnevnega nadzora po vsakem injiciranju cepiva Gardasil ali placeba s pomočjo kartončkov za poročanje (vaccination report card (VRC) - aided surveillance).
The subjects who were monitored using VRC-aided surveillance included 6,160 subjects (5,088 females 9 to 26 years of age and 1,072 males 9 to 15 years of age at enrolment) who received Gardasil and 4,064 subjects who received placebo.
S pomočjo kartončkov za poročanje je bilo nadziranih 6. 160 oseb, ki so prejele cepivo Gardasil (5. 088 oseb ženskega spola, ki so bile ob vključitvi stare od 9 do 26 let in 1. 072 oseb moškega spola, ki so bile ob vključitvi stare od 9 do 15 let), ter 4. 064 oseb, ki so prejele placebo.
The following vaccine-related adverse reactions were observed among recipients of Gardasil at a frequency of at least 1.0% and also at a greater frequency than observed among placebo recipients.
V nadaljevanju so navedeni s cepivom povezani neželeni učinki, opaženi pri osebah, ki so prejele cepivo Gardasil, katerih pogostost je bila vsaj 1, 0% in tudi večja od pogostosti pri osebah, ki so prejele placebo.
They are ranked under headings of frequency using the following convention:
Pogostost je navedena v skladu z naslednjim dogovorom:
[Very Common (≥ 1/ 10); Common (≥ 1/ 100,  1/ 10); Uncommon (≥ 1/ 1,000,  1/ 100); Rare (≥ 1/ 10,000,  1/ 1,000); Very Rare ( 1/ 10,000), including isolated reports]
[Zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100); redki (≥ 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000), vključno s posameznimi primeri]
Common: at the injection site: bruising, pruritus.
Zelo pogoste: zvišana telesna temperatura Zelo pogoste: na mestu aplikacije: eritem, bolečina, oteklina Pogoste: na mestu aplikacije: modrica, srbenje
Very rare: bronchospasm.
Med kliničnimi preskušanji so se pojavili tudi neželeni učinki, katerih pogostost je bila manjša od 1%, in so bili po presoji raziskovalcev povezani s cepivom ali s placebom:
Skin and subcutaneous tissue disorder:
Bolezni dihal, prsnega koša in mediastinalnega prostora:
Rare: urticaria.
Zelo redki: bronhospazem
Seven cases (0.06%) of urticaria were reported in the Gardasil group and 17 cases (0.18%) were seen in the adjuvant-containing placebo group.
Redki: urtikarija V skupini, ki je prejemala cepivo Gardasil so poročali o sedmih primerih (0, 06%) urtikarije, v skupini, ki je prejemala placebo, ki je vseboval adjuvans, pa o 17- ih primerih (0, 18%).
In the clinical studies, subjects in the Safety Population reported any new medical conditions during the follow-up of up to 4 years.
Med 11. 778 osebami, ki so prejele Gardasil, in 9. 686 osebami, ki so prejele placebo, je bilo 28 poročil o primeru nespecifičnega artritisa/ artropatije:
Among 11,778 subjects who received Gardasil and 9,686 subjects who received placebo, there were 28 cases of non-specific arthritis/ arthropathy reported, 20 in the Gardasil group and 8 in the placebo group.
20 v skupini, ki je prejela Gardasil, in 8 v skupini, ki je prejela placebo.
Post Marketing adverse events have been spontaneously reported for Gardasil and are not listed above.
Spodaj so navedeni neželeni učinki, o katerih so spontano poročali po pridobitvi dovoljenja za promet z zdravilom Gardasil.
Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure.
Ker so o teh neželenih učinkih poročali prostovoljno in ne poznamo točne velikosti populacije, ne moremo zanesljivo oceniti njihove pojavnosti in za vse dogodke ugotoviti vzročno povezavo s cepivom.
Blood and lymphatic system disorders: lymphadenopathy.
Bolezni krvi in limfatičnega sistema: limfadenopatija.
Immune system disorders: hypersensitivity reactions including anaphylactic/ anaphylactoid reactions.
Bolezni imunskega sistema: preobčutljivostne reakcije, vključno z anafilaktičnimi/ anafilaktoidnimi reakcijami.
Guillain-Barré syndrome, dizziness, headache, syncope sometimes accompanied by tonic-clonic movements.
Guillain- Barréjev sindrom, omotica, glavobol, sinkopa, včasih s spremljajočimi klonično- toničnimi gibi.
Gastrointestinal disorders: nausea, vomiting.
5 Bolezni prebavil: navzea, bruhanje.
Musculoskeletal and connective tissue disorders: arthralgia, myalgia.
Bolezni mišično- skeletnega sistema in vezivnega tkiva: artralgija, mialgija.
5 General disorders and administration site conditions: asthenia, fatigue, malaise.
Splošne težave in spremembe na mestu aplikacije: astenija, utrujenost, slabost.
Viral Vaccine, ATC code:
Virusna cepiva, oznaka ATC:
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.
Gardasil je nekužno rekombinantno štirivalentno cepivo z adjuvansom, pripravljeno iz visoko prečiščenih virusu podobnih delcev (VLPs - virus- like particles) velike (L1) plaščne beljakovine tipov 6, 11, 16 in 18 HPV.
HPV 16 and HPV 18 are estimated to be responsible for approximately 70% of cervical cancers; 80% of adenocarcinoma in situ (AIS); 45-70% of high-grade cervical intraepithelial neoplasia (CIN 2/ 3); 25% of low grade cervical intraepithelial neoplasia (CIN 1); approximately 70% of HPV related high- grade vulvar (VIN 2/ 3) and vaginal (VaIN 2/ 3) intraepithelial neoplasia.
HPV 16 in HPV 18 sta po ocenah odgovorna za približno 70% primerov raka materničnega vratu, 80% primerov adenokarcinoma in situ (AIS), 45- 70% primerov cervikalne intraepitelijske neoplazije hude stopnje (CIN 2/ 3), 25% primerov cervikalne intraepitelijske neoplazije blage stopnje (CIN 1) ter približno 70% primerov s HPV povezane intraepitelijske neoplazije hude stopnje na vulvi (VIN 2/ 3) in nožnici (VaIN 2/ 3).
HPV 6 and 11 are responsible for approximately 90% of genital warts and 10% of low grade cervical intraepithelial neoplasia (CIN 1).
HPV 6 in 11 sta odgovorna za približno 90% primerov bradavic na spolovilih in 10% cervikalne intraepitelijske neoplazije blage stopnje (CIN 1).
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 high- grade vaginal intraepithelial neoplasia (VaIN 2/ 3).
Izraz "predrakave genitalne lezije" v poglavju 4. 1 predstavlja cervikalno intraepitelijsko neoplazijo hude stopnje (CIN 2/ 3), intraepitelijsko neoplazijo hude stopnje na vulvi (VIN 2/ 3) in intraepitelijsko neoplazijo hude stopnje na nožnici (VaIN 2/ 3).
The efficacy of Gardasil was assessed in 4 placebo-controlled, double-blind, randomized Phase II and III clinical studies including a total of 20,541 16- to 26-year old women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Učinkovitost cepiva Gardasil je bila ovrednotena v 4- ih s placebom nadzorovanih, dvojno slepih, randomiziranih kliničnih študijah II. in III. faze, v katere je bilo vključenih skupno 20. 541 žensk, starih 16 do 26 let, ki so bile v študije vključene in cepljene brez predhodnega pregleda za prisotnost okužbe s HPV.
The primary efficacy endpoints included HPV 6-, 11-, 16-, or 18-related vulvar and vaginal lesions (genital warts, VIN, VaIN) and CIN of any grade (Protocol 013, FUTURE I), HPV 16- or 18-related CIN 2/ 3 and AIS (Protocol 015, FUTURE II), HPV 6-, 11-, 16-, or 18-related persistent infection (Protocol 007), and HPV 16-related persistent infection (Protocol 005).
Primarni opazovani dogodki so zajemali s HPV 6, HPV 11, HPV 16 ali HPV 18 povezane spremembe na vulvi in nožnici (bradavice na spolovilih, VIN, VaIN) ter CIN katerekoli stopnje (Protokol 013, Future I), s HPV 16 ali HPV 18 povezane CIN 2/ 3 in AIS (Protokol 015, FUTURE II), s HPV 6, HPV 11, HPV 16 ali HPV 18 povezano persistentno okužbo (Protokol 007) in s HPV 16 povezano persistentno okužbo (Protokol 005).
The efficacy for HPV 16/ 18 related CIN 2/ 3 or AIS is based on data from protocols 005 (16-related endpoints only), 007, 013, and 015.
Učinkovitost proti CIN 2/ 3 ali AIS zaradi HPV 16/ 18 temelji na podatkih iz protokolov 005 (le s HPV 16 povezani opazovani dogodki) in 007, 013 ter 015.
The efficacy for all other endpoints is based on protocols 007, 013, and 015.
6 temelji na protokolih 007, 013 in 015.
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.
Srednji čas spremljanja v teh študijah je bil 4, 0 let za Protokol 005, ter 3, 0 let za Protokol 007, Protokol 013 in Protokol 015.
The median duration of follow-up for the combined protocols (005, 007, 013, and 015) was 3.6 years.
Srednji čas spremljanja za kombinacijo protokolov (005, 007, 013 in 015) je bil 3, 6 let.
Gardasil was efficacious against HPV disease caused by each of the four vaccine HPV type.
Cepivo Gardasil je bilo učinkovito proti boleznim zaradi HPV, ki jih povzroča katerikoli od tipov HPV, ki jih vsebuje cepivo.
At end of study, subjects enrolled in the two Phase-III studies (Protocol-013 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).
6 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.
V kliničnih preskušanjih sta bila cervikalna intraepitelijska neoplazija (CIN) stopnje 2/ 3 (displazija zmerne do hude stopnje) in adenokarcinom in situ (AIS) uporabljena kot nadomestna klinična označevalca raka materničnega vratu.
Prophylactic Efficacy against Vaccine HPV Types (HPV 6, 11, 16, or 18)
Učinkovitost profilakse proti tipom HPV, ki jih vsebuje cepivo (HPV 6, 11, 16 ali 18)
The primary analyses of efficacy, with respect to vaccine HPV types (HPV 6, 11, 16, and 18), were conducted in the per-protocol efficacy (PPE) population (n= all 3 vaccinations within 1 year of enrolment, no major protocol deviations and naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7)).
Primarna analiza učinkovitosti je bila glede na tipe HPV v cepivu (HPV 6, 11, 16 in 18) izvedena po per- protokolu učinkovitosti (PPE - per- protocol efficacy) v populaciji (n = vsi 3 odmerki cepiva v 1 letu po vključitvi, brez bistvenih odstopanj od protokola ter pred prejemom 1. odmerka in 1 mesec po prejemu 3. odmerka cepiva (7. mesec) niso bile izpostavljene relevantnemu tipu (relevantnim tipom) HPV).
Overall, 73% of subjects were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
73% vseh oseb ob vključitvi še ni bilo izpostavljeno nobenemu od 4 tipov HPV (PCR negativne in seronegativne).
Efficacy in subjects naïve to the relevant vaccine HPV type(s)
Učinkovitost pri osebah, ki še niso bile v stiku z relevantnim tipom (relevantnimi tipi) HPV, ki jih vsebuje cepivo
The efficacy results for relevant endpoints analysed at 2 years post-enrolment and at end of study (median duration of follow-up = 3.6 years) in the per-protocol population are presented in the Table 1.
Analize so bile opravljene dve leti po vključitvi in na koncu študije (srednji čas spremljanja = 3, 6 let).
In a supplemental analysis, the efficacy of Gardasil was evaluated against HPV 16/ 18-related CIN 3 and AIS.
Z dodatno analizo je bila ovrednotena še učinkovitost cepiva Gardasil proti CIN 3 in AIS zaradi HPV 16/ 18.
Analysis of efficacy of Gardasil against high grade cervical lesions in the PPE population
Analiza učinkovitosti cepiva Gardasil proti spremembam na materničnem vratu hude stopnje v PPE populaciji
Number Number
Gardasil Placebo
Number
učinkovitosti
Efficacy***
učinkovitosti ***
of cases of cases
Število Število
Efficacy of cases
Število po 2 letih
of cases
Število
at end of
na koncu
Number Number
primerov primerov Število Število
at 2 years Number
(95- odstotni
Number Number at 2 years Number Number
primerov primerov Število Število
study
študije
of of
IZ)
of of (95% CI) of of
(95- odstotni IZ)
subjects* subjects*
oseb * oseb *
subjects* subjects*
oseb *
0 53
oseb *
98.2
(93, 5; 99, 8)
CIN 2/ 3 or AIS
povezana s HPV 16/ 18
8487
8. 487
8460
8. 460
(92.9, 100.0)
8. 493
8493
8. 464
0 8487
CIN 3,
2** 8493
8. 464
HPV 16/ 18-related
AIS, povezana s
AIS
HPV 16/ 18
(14.8, 100.0)
8. 493
*Number of subjects with at least one follow-up visit after Month 7 **Based on virologic evidence, this CIN 3 case in a patient chronically infected with HPV 52 is likely to be causally related to HPV 52.
* Število oseb z vsaj enim kontrolnim obiskom po 7. mesecu. ** Na osnovi viroloških dokazov je bil ta primer CIN 3 pri osebi s kronično okužbo s HPV 52 verjetno vzročno povezan s HPV 52.
In only 1 of 11 specimens HPV 16 was found (at Month 32.5) and was not detected in tissue excised during LEEP (Loop Electro-Excision Procedure).
HPV 16 je bil odkrit le v enem od 11 vzorcev (po 32, 5 mesecih) in ga niso odkrili pri eksciziji tkiva s postopkom LEEP (“ Loop Electro- Excision Procedure ”).
In the second CIN 3 case observed in a patient infected with HPV 51 at Day 1 (in 2 of 9 specimens); HPV 16 was detected at a Month 51 biopsy (in 1 of 9 specimens) and HPV 56 was detected in 3 of 9 specimens at Month 52 in tissue excised during LEEP. ***Patients were followed for up to 4 years (median 3.6 years) Note:
Pri drugem opaženem primeru CIN 3 pri bolnici z okužbo s HPV 51 na 1. dan (v 2 od 9 vzorcev) je bil v 51. mesecu z biopsijo odkrit HPV 16 (v 1 od 9 vzorcev), v 52. mesecu pa je bil v 3 od 9 vzorcev pri eksciziji tkiva s postopkom LEEP odkrit HPV 56. *** Bolnice so spremljali do 4 leta (mediana 3, 6 let) Opomba:
Point estimates and confidence intervals are adjusted for person-time of follow-up.
Ocenjene vrednosti in intervali zaupanja so prilagojeni glede na čas spremljanja osebe.
At end of study and in the combined protocols,
7 Ob koncu študije in v kombinaciji protokolov je bila
91.4, 98.4) the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0% (95% CI:
učinkovitost cepiva Gardasil proti s HPV 6, 11, 16 in 18 povezanim CIN (1, 2, 3) ali AIS 96, 0% (95 - odstotni IZ:
the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related VIN2/ 3 and VaIN 2/ 3 was 100% (95% CI:
67, 2; 100) oz.
67.2, 100) and 100% (95% CI:
100% (95- odstotni IZ:
55.4, 100) respectively
55, 4; 100).
7 the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
učinkovitost cepiva Gardasil proti s HPV 6, 11, 16 in 18 povezanimi bradavicami 99, 0% (95- odstotni IZ:
In Protocol 012 the efficacy of Gardasil against the 6 month definition of persistent infection [samples positive on two or more consecutive visits 6 months apart (±1 month) or longer] related to HPV 16 was 98.7% (95% CI:
V protokolu 012 je bila učinkovitost cepiva Gardasil na podlagi 6 mesečne definicije persistentne okužbe [pozitiven vzorec na dveh ali več zaporednih obiskih v vsaj 6 mesečnen razmiku (± 1 mesec)] po 4 letnem spremljanju (povprečno 3, 6 let) za HPV 16 98, 7% (95- odstotni IZ:
95.1, 99.8) and 100.0% (95% CI:
95, 1, 99, 8), za HPV 18 pa 100, 0% (95- odstotni IZ:
For the 12 month definition of persistent infection, efficacy against HPV 16 was 100.0% (95% CI:
Na podlagi 12 mesečne definicije persistentne okužbe je bila učinkovitost proti HPV 16 100, 0% (95- odstotni IZ:
93.9, 100.0) and 100.0% (95% CI:
93, 9, 100, 0) ter proti HPV 18 100% (95 - odstotni IZ:
Efficacy in individuals with evidence of HPV 6, 11, 16, or 18 infection or disease at day 1
Učinkovitost pri osebah z znaki okužbe s HPV 6, 11, 16 ali 18 ali z boleznijo na 1. dan
There was no evidence of protection from disease caused by vaccine HPV types for which subjects were PCR positive at day 1.
Dokazov o zaščiti pred boleznijo, povzročeno s tipi HPV, ki jih vsebuje cepivo, na katere so bile osebe PCR pozitivne na 1. dan, ni bilo.
Individuals 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 types.
Posamezniki, ki so pred cepljenjem že bili okuženi z enim ali več tipi HPV, ki jih vsebuje cepivo, so bili zaščiteni pred klinično boleznijo zaradi preostalih tipov HPV, ki jih vsebuje cepivo.
Efficacy in subjects with and without prior infection or disease due to HPV 6, 11, 16, or 18
Učinkovitost pri osebah s predhodno okužbo ali boleznijo zaradi HPV 6, 11, 16 ali 18 ali brez
The modified intention to treat (ITT) population included women regardless of baseline HPV status at Day 1, who received at least one vaccination and in whom case counting started at 1 month Postdose 1.
Modificirana ITT (intention- to- treat) populacija je vključevala ženske ne glede na HPV status na 1. dan, ki so prejele vsaj en odmerek cepiva, štetje primerov pa se je začelo 1 mesec po cepljenju s 1. odmerkom.
This population approximates to the general population of women with respect to prevalence of HPV infection or disease at enrolment.
Ti rezultati so povzeti v preglednici 2.
The results are summarised in Table 2.
Preglednica 2:
Efficacy of Gardasil in high grade cervical lesions in the modified ITT-population including women regardless of baseline HPV status
Učinkovitost cepiva Gardasil proti spremembam na materničnem vratu hude stopnje v modificirani ITT populaciji žensk ne glede na začetni HPV status
Number of Number
Gardasil Placebo
Number
učinkovitosti ** učinkovitosti **
Efficacy**
Število Število
cases
Število Število po 2 letih
of cases
na koncu
Efficacy** of cases
primerov primerov
of cases
primerov primerov (95- odstotni
at end of
študije
Number of Number
(95- odstotni
at 2 years Num
Število Število
study
Število IZ)
subjects*
Število
of
IZ)
(95% CI) of of
oseb * oseb *
(95% CI)
oseb * 39, 0
subjects*
oseb *
HPV 16- or HPV
CIN 2/ 3 ali
146 303
146
51.8
303
18-related CIN 2/ 3 or AIS
(23, 3; 51, 7)
(23.3, 51.7)
(41, 1; 60, 7)
9836
9. 896
9904
9. 836
(41.1, 60.7)
9. 904
HPV 16/ 18- related CIN 3
CIN 3,
46.0 (31.0, 57.9)
(31, 0; 57, 9)
HPV 16/ 18-
povezana s HPV 16/ 18
9831
povezana s HPV 16/ 18
9896
9. 831
(< 0, 87.3)
9. 904
*Number of subjects with at least one follow-up visit after 30 days after Day 1 **Percent efficacy is calculated from the combined protocols.
* Število oseb z vsaj enim kontrolnim obiskom po 30 dneh po 1. dnevu. ** Odstotek učinkovitosti je izračunan iz kombinacije protokolov.
The efficacy for HPV 16/ 18 related CIN 2/ 3 or AIS is based on data from protocols 005 (16-related endpoints only), 007, 013, and 015.
Učinkovitost proti s HPV 16/ 18 povezanim CIN 2/ 3 ali AIS temelji na podatkih iz protokolov 005 (le s HPV 16 povezani opazovani dogodki) in 007, 013 ter 015.
Patients were followed for up to 4 years (median 3.6 years).
Bolnice so spremljali do 4 leta (mediana 3, 6 let).
Note: point estimates and confidence intervals are adjusted for person-time of follow-up.
Opomba: ocenjene vrednosti in intervali zaupanja so prilagojeni glede na čas spremljanja osebe.
Efficacy against HPV 6-, 11-, 16-, 18-related VIN 2/ 3 was 73.3% (95% CI:
V kombinaciji protokolov je bila na koncu študije učinkovitost proti s HPV 6, HPV 11, HPV 16 ali HPV 18 povezanim VIN 2/ 3 73, 3% (95- odstotni IZ:
40.3, 89.4), against HPV 6-, 11-, 16-, 18-related VaIN 2/ 3 was 85.7% (95% CI:
40, 3; 89, 4), proti s HPV 6, HPV 11, HPV 16 ali HPV 18 povezanim VaIN 2/ 3 85, 7% (95- odstotni IZ:
37.6, 98.4), and against HPV 6-, 11-, 16-, 18- related genital warts was 80.3% (95% CI:
37, 6; 98, 4), proti s HPV 6, HPV 11, HPV 16 ali HPV 18 povezanimi bradavicami na spolovilih pa 80, 3 (95- odstotni IZ:
73.9, 85.3) in the combined protocols at end of study.
73, 9; 85, 3).
Overall 12% of the combined study population had an abnormal Pap test suggestive of CIN at Day 1.
V celoti je 12% vseh v študijo vključenih oseb imelo na 1. dan nenormalni Pap test, ki je kazal na CIN.
Among subjects with an abnormal Pap test at Day 1 who were naïve to the relevant vaccine HPV types at Day 1, efficacy of the vaccine remained high.
Pri osebah, ki so imele na 1. dan nenormalni Pap test in do tega dne še niso bile v stiku z relevantnimi tipi HPV, ki jih vsebuje cepivo, je učinkovitost cepiva ostala visoka.
Among subjects with an abnormal Pap test at Day 1 who were already infected with the relevant vaccine HPV types at Day 1, no vaccine efficacy was observed.
Pri osebah, ki so imele na 1. dan nenormalni Pap test in so do tega dne že bile okužene z relevantnimi tipi HPV, ki jih vsebuje cepivo, pa niso opazili nobene učinkovitosti cepiva.
8 Protection Against the Overall Burden of Cervical HPV disease in 16- Through 26-Year-Old Women
Zaščita pred celotnim bremenom bolezni materničnega vratu zaradi HPV pri ženskah, starih od 16 do 26 let
The impact of Gardasil 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 subjects enrolled in the two phase III efficacy trials (Protocols 013 and 015).
Vpliv cepiva Gardasil proti celotnemu tveganju za bolezen materničnega vratu zaradi HPV (to je proti boleznim zaradi kateregakoli 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).
Among subjects who were naïve to 14 common HPV types and had a negative Pap test at Day 1, administration of Gardasil reduced the incidence of CIN 2/ 3 or AIS caused by vaccine- or non-vaccine HPV types by 42.7% (95% CI:
Pri osebah, ki so bile negativne na 14 pogostih tipov HPV in so imele na 1. dan negativni Pap test, se je na koncu študije s cepivom Gardasil pojavnost CIN 2/ 3 ali AIS zaradi tipov HPV, ki jih ali jih ne vsebuje cepivo, zmanjšala za 42, 7% (95- odstotni IZ: