natgillin/translations-raw huggingface dataset:
In studies, the most common side effects with Silgard (seen in more than 1 patient in 10) were pyrexia (fever) and reactions at the site of the injection (redness, pain and swelling).
V okviru študij so bili najpogostejši neželeni učinki zdravila Silgard (opaženi pri več kot 1 bolnici izmed 10) povišana telesna temperatura in reakcije na mestu injiciranja (rdečina, bolečina in oteklina).
For the full list of all side effects reported with Silgard, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Silgard, glejte navodilo za uporabo.
Silgard should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients.
Zdravila Silgard ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilno učinkovino ali katero koli drugo sestavino zdravila.
If a patient shows signs of an allergy after a dose of Silgard, she should not receive further doses of the vaccine.
Če bolnica po prejemu odmerka zdravila Silgard kaže znake alergije, potem nadaljnjih odmerkov cepiva ne sme prejeti.
The Committee for Medicinal Products for Human Use (CHMP) decided that Silgard’ s benefits are greater than its risks as a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to HPV types 6, 11, 16 and 18.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Silgard kot cepiva za preprečevanje predrakavih genitalnih lezij (na materničnem vratu, zunanjih in notranjih ženskih spolovilih), raka materničnega vratu in bradavic na zunanjih spolovilih (koničastih kondilomov), ki so vzročno povezani s HPV tipov 6, 11, 16 in 18, večje od z njim povezanih tveganj.
The Committee recommended that Silgard be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Silgard odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Silgard to Merck Sharp & Dohme Ltd. on 20 September 2006.
Evropska komisija je dovoljenje za promet z zdravilom Silgard, veljavno po vsej Evropski uniji, odobrila družbi Merck Sharp & Dohme Ltd dne 20. septembra 2006.
The full EPAR for Silgard can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Silgard je na voljo tukaj.
Pharmaceutical Form Suspension for injection Suspension for injection Suspension for injection Suspension for injection Suspension for injection
Suspenzija za injiciranje
Route of Administration Intramuscular use Intramuscular use Intramuscular use Intramuscular use Intramuscular use
viala
Packaging vial (glass) vial (glass) pre-filled syringe (glass) pre-filled syringe (glass) pre-filled syringe (glass)
-- 1
Content 0.5 ml 0.5 ml 0.5 ml 0.5 ml 0.5 ml
1 napolnjena injekcijska brizga
EU/ 1/ 06/ 358/ 006
EU/ 1/ 06/ 358/ 005
Intramuscular use
napolnjena injekcijska brizga
20 pre-filled syringes with needle guard + 40 needles
20 napolnjenih injekcijskih brizg z varovalom za iglo + 40 igel
Suspension for injection Suspension for injection
Suspenzija za injiciranje
Intramuscular use Intramuscular use
Intramuskularna uporaba
vial (glass) pre-filled syringe (glass)
viala
0.5 ml 0.5 ml
0. 5 ml
20 vials 20 pre-filled syringes
20 vial
20 pre-filled syringes + 20 needles
20 napolnjenih injekcijskih brizg
pre-filled syringe (glass)
Suspenzija za injiciranje
1 1 dose (0.5 ml) contains approximately:
1 odmerek (0, 5 ml) vsebuje približno:
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Silgard suspenzija za injiciranje adsorbirano rekombinantno cepivo proti humanim papilomavirusom [tipom 6, 11, 16 in 18]
Silgard is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18 (see section 5.1).
Silgard je cepivo za preprečevanje predrakavih genitalnih lezij (cervikalnih, vulvarnih in vaginalnih), raka materničnega vratu in bradavic na zunanjih spolovilih (koničasti kondilomi), ki so vzročno povezani s tipi 6, 11, 16 in 18 humanih papilomavirusov (HPV) (glejte poglavje 5. 1).
The indication is based on the demonstration of efficacy of Silgard in adult females 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 odraslih ženskah, starih od 16 do 26 let, in dokazu imunogenosti cepiva Silgard pri 9 do 15 let starih otrocih in mladostnikih.
Paediatric population:
2 Otroci:
Silgard is not recommended for use in children below 9 years of age due to
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba cepiva Silgard pri otrocih, mlajših od 9 let, ni priporočljiva (glejte poglavje 5. 1).
Silgard must not be injected intravascularly.
Cepiva Silgard se ne sme vbrizgati intravaskularno.
It is recommended that subjects who receive a first dose of Silgard complete the 3-dose vaccination course with Silgard (see section 4.4).
Pri osebah, ki so že prejele prvi odmerek cepiva Silgard je priporočljivo, da se cepljenje dokonča s cepivom Silgard in osebe tako prejmejo vse 3 odmerke istega cepiva (glejte poglavje 4. 4).
Administration of Silgard should be postponed in subjects 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.
Syncope, sometimes associated with falling, has occurred after vaccination with Silgard (See section 4.8).
Sinkopa, včasih skupaj s padcem, se je pojavila po cepljenju s cepivom Silgard (glejte poglavje 4. 8).
Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of Silgard.
Zato je po cepljenju s cepivom Silgard cepljene osebe potrebno skrbno opazovati približno 15 minut.
Silgard will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to a limited extent against diseases caused by certain related HPV types (See section 5.1).
Cepivo Silgard ščiti le pred boleznimi, ki jih povzročajo tipi 6, 11, 16 in 18 HPV, ter v določeni meri pred boleznimi, ki jih povzročajo določeni sorodni tipi HPV (glejte poglavje 5. 1).
Since no vaccine is 100% effective and Silgard will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.
Ker učinkovitost nobenega cepiva ni 100- odstotna in ker cepivo Silgard ne ščiti pred vsemi tipi HPV oziroma pred že obstoječimi okužbami, rutinska presejanja raka materničnega vratu ostajajo kritičnega pomena in jih je treba izvajati v skladu z lokalnimi priporočili.
There are no data on the use of Silgard in subjects with impaired immune responsiveness.
Podatki o uporabi cepiva Silgard pri osebah z okvarjenim imunskim odzivom niso na voljo.
Sustained protective efficacy has been observed for 4.5 years after completion of the 3-dose series.
Ugotovljena je bila persistentna zaščitna učinkovitost, ki je trajala 4, 5 let po dokončanju cepljenja s 3 odmerki.
3 There are no safety, immunogenicity or efficacy data to support interchangeability of Silgard with other HPV vaccines.
Podatki o varnosti, imunogenosti ali učinkovitosti, ki bi podpirali zamenljivost cepiva Silgard z drugimi cepivi proti HPV, niso na voljo.
The seroprotection rates (proportion of subjects reaching seroprotective level anti-HBs > 10 mIU/ ml) were unaffected (96.5% for concomitant vaccination and 97.5% for hepatitis B vaccine only).
Odstotek serozaščite (delež oseb, pri katerih je bila dosežena raven serozaščite anti- HBs ≥ 10 mi. e. / ml) je ostal nespremenjen (96, 5% pri sočasnem cepljenju in 97, 5% pri cepljenju samo s cepivom proti hepatitisu B).
The concomitant administration of Silgard with vaccines other than hepatitis B (recombinant) vaccine has not been studied.
Sočasnega cepljenja s cepivom Silgard in z drugimi cepivi (razen z rekombinantnim cepivom proti hepatitisu B) niso raziskali.
In clinical studies, 57.5% of women (age 16 to 26 years) who received Silgard used hormonal contraceptives.
V kliničnih študijah je 57, 5% žensk (starih od 16 do 26 let), ki so prejele cepivo Silgard, uporabljalo hormonske kontraceptive.
There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in Silgard and placebo treated subjects.
Razlike v vrsti nenormalnosti ali deležu nosečnosti z neželenim izidom pri osebah, zdravljenih s cepivom Silgard, in pri osebah, zdravljenih s placebom, niso bile značilne.
In breastfeeding mothers given Silgard 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 Silgard 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 Silgard can be given to breastfeeding women.
Doječe matere se zato lahko cepi s cepivom Silgard.
In 5 clinical trials (4 placebo-controlled), subjects were administered Silgard 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 Silgard ali placebo prejele na dan vključitve in nato približno čez 2 in 6 mesecev.
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
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 Silgard 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 Silgard and 4,064 subjects who received placebo.
S pomočjo kartončkov za poročanje je bilo nadziranih 6. 160 oseb, ki so prejele cepivo Silgard (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 Silgard 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 Silgard, katerih pogostost je bila vsaj 1, 0% in tudi večja od pogostosti pri osebah, ki so prejele placebo.
[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]
In addition, in clinical trials adverse reactions that were judged to be vaccine- or placebo-related by the study investigator were observed at frequencies lower than 1%:
Zelo pogoste: zvišana telesna temperatura Zelo pogoste: na mestu aplikacije: eritem, bolečina, oteklina Pogoste: na mestu aplikacije: modrica, srbenje
Seven cases (0.06%) of urticaria were reported in the Silgard group and 17 cases (0.18%) were seen in the adjuvant-containing placebo group.
Redki: urtikarija V skupini, ki je prejemala cepivo Silgard 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 Silgard, in 9. 686 osebami, ki so prejele placebo, je bilo 28 poročil o primeru nespecifičnega artritisa/ artropatije:
Among 11,778 subjects who received Silgard and 9,686 subjects who received placebo, there were 28 cases of non-specific arthritis/ arthropathy reported, 20 in the Silgard group and 8 in the placebo group.
20 v skupini, ki je prejela Silgard, in 8 v skupini, ki je prejela placebo.
Post Marketing adverse events have been spontaneously reported for Silgard and are not listed above.
Neželeni učinki, o katerih so spontano poročali v času trženja zdravila Silgard in niso navedeni zgoraj.
General disorders and administration site conditions: asthenia, fatigue, malaise.
Splošne težave in spremembe na mestu aplikacije: astenija, utrujenost, slabost.
5 In general, the adverse event profile reported with overdose was comparable to recommended single doses of Silgard.
Profil neželenih dogodkov, o katerih so poročali pri prevelikem odmerjanju, je bil na splošno primerljiv s profilom pri priporočenem enkratnem odmerku cepiva Silgard.
Viral Vaccine, ATC code:
5. 1 Farmakodinamične lastnosti
Silgard 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.
Silgard 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.
The efficacy of Silgard 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 Silgard 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.
Silgard was efficacious against HPV disease caused by each of the four vaccine HPV type.
Cepivo Silgard je bilo učinkovito proti boleznim zaradi HPV, ki jih povzroča katerikoli od tipov HPV, ki jih vsebuje cepivo.
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.
6 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).
In a supplemental analysis, the efficacy of Silgard was evaluated against HPV 16/ 18-related CIN 3 and AIS.
Z dodatno analizo je bila ovrednotena še učinkovitost cepiva Silgard proti CIN 3 in AIS zaradi HPV 16/ 18.
Analysis of efficacy of Silgard against high grade cervical lesions in the PPE population
Analiza učinkovitosti cepiva Silgard proti spremembam na materničnem vratu hude stopnje v PPE populaciji
% Number
učinkovitosti
Efficacy of cases
po 2 letih
Number Number at 2 years Number Number
primerov primerov primerov primerov
study
(95 -
of of
študije
(95% CI) of
Število Število
of of (95% CI) of of
Število
(95% CI)
Število
subjects* subjects*
odstotni IZ)
subjects* subjects*
(95- odstotni IZ)
0 53
oseb * oseb * 0
100.0
oseb * 100, 0
CIN 2/ 3 or AIS
AIS, povezana s HPV 16/ 18
HPV 16/ 18-related
povezana s HPV 16/ 18
the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9% (95% CI:
učinkovitost cepiva Silgard proti s HPV 6, 11, 16 in 18 povezanim CIN 1 95, 9% (95- odstotni IZ:
the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0% (95% CI:
učinkovitost cepiva Silgard proti s HPV 6, 11, 16 in 18 povezanim CIN (1, 2, 3) ali AIS 96, 0% (95 - odstotni IZ:
the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related VIN2/ 3 and VaIN 2/ 3 was 100% (95% CI:
učinkovitost cepiva Silgard proti s HPV 6, 11, 16 in 18 povezanim VIN 2/ 3 oz.
67.2, 100) and 100% (95% CI:
VaIN 2/ 3 100% (95 - odstotni IZ:
55.4, 100) respectively
100% (95- odstotni IZ:
the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
učinkovitost cepiva Silgard proti s HPV 6, 11, 16 in 18 povezanimi bradavicami 99, 0% (95- odstotni IZ:
In Protocol 012 the efficacy of Silgard 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 Silgard 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:
7 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
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.
Efficacy of Silgard in high grade cervical lesions in the modified ITT-population including women regardless of baseline HPV status
Učinkovitost cepiva Silgard proti spremembam na materničnem vratu hude stopnje v modificirani ITT populaciji žensk ne glede na začetni HPV status
Placebo Silgard
Placebo
Placebo
Silgard Placebo%
Number of Number
učinkovitosti ** učinkovitosti ** Število
Number
Število Število
Efficacy**
po 2 letih
cases
Število primerov primerov
of cases
(95- odstotni
Number of Number at 2 years Number Number
Število Število
subjects*
Število IZ)
subjects*
IZ)
122
oseb * oseb * 122
18-related CIN 2/ 3 or AIS
AIS, povezana s HPV 16/ 18
9831
9. 831
9896
9. 896
(23.3, 51.7)
9. 836
9836
9. 904
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 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 subjects 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 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 Silgard 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 Silgard pojavnost CIN 2/ 3 ali AIS zaradi tipov HPV, ki jih ali jih ne vsebuje cepivo, zmanjšala za 42, 7% (95- odstotni IZ:
23.7, 57.3) and of genital warts by 82.8% (95% CI:
23, 7; 57, 3), pojavnost bradavic na spolovilih pa za 82, 8% (95 - odstotni IZ:
74.3, 88.8) at end of study.
74, 3; 88, 8).
In the modified ITT population, the benefit of the vaccine with respect to the overall incidence of CIN 8 2/ 3 or AIS (caused by any HPV type) and of genital warts was much lower, with a reduction of 18.4% (95% CI:
V modificirani ITT populaciji je bila korist cepiva glede na celotno pojavnost CIN 2/ 3 ali AIS (zaradi kateregakoli tipa HPV) in bradavic na spolovilih veliko manjša, in sicer se je pojavnost CIN 2/ 3 zmanjšala za 18, 4% (95- odstotni IZ:
54.0, 69.5), respectively, as Silgard does not impact the course of infections or disease that are present at vaccination onset.
54, 0; 69, 5), saj cepivo Silgard ne vpliva na potek okužbe ali bolezni, ki sta ob začetku cepljenja že prisotni.
The impact of Silgard on rates of Definitive Cervical Therapy Procedures regardless of causal HPV types was evaluated in 18,150 subjects 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.
In the HPV naïve population (naïve to 14 common HPV types and had a negative Pap test at Day 1), Silgard 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:
V populaciji, ki še ni bila v stiku s HPV (negativna na 14 pogostih tipov HPV in negativen Pap test na 1. dan), je cepivo Silgard na koncu študije zmanjšalo delež žensk, pri katerih je bil opravljen definitivni terapevtski poseg na materničnem vratu (“ Loop Electro- Excision Procedure ” ali “ Cold- Knife Conization ”) za 41, 9% (95- odstotni IZ:
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
Results for CIN 2/ 3 or AIS in Type-Specific HPV-Naïve Subjects† (end of study results) Naïve to ≥ 1 HPV Type
Rezultati za CIN 2/ 3 ali AIS pri osebah, ki še niso bile okužene s tipsko specifičnimi HPV † (rezultati ob koncu študije) Negativne za ≥ 1 tip HPV Sestavljeni opazovani dogodek
Silgard
Silgard primeri
Placebo
Placebo primeri
(HPV 31/ 45)
95- odstotni IZ
(HPV 31/ 33/ 45/ 52/ 58) §
(HPV 31/ 45) ‡ (HPV 31/ 33/ 45/ 52/ 58) §
111
34 111
150
60 150
25.8%
43, 2% 25, 8%
4.6, 42.5
12, 1; 63, 9 4, 6; 42, 5
10 non-vaccine HPV Types║
10 tipov HPV║, ki jih cepivo ne vsebuje
5.1, 37.7
5, 1; 37, 7
26.2, 74.1† < 0, 52.1† < 0, 61.9† < 0, 44.2† < 0, 61.0†
26, 2; 74, 1 < 0; 52, 1 < 0; 61, 9 < 0; 44, 2 < 0; 61, 0 < 0; 53, 9
HPV 39 HPV 45 HPV 59
HPV 39 HPV 45 HPV 59 vrste A5 (HPV 51) vrste A6 (HPV 56) †
-13.7%
24 11 15 41 30
9 Naïve to ≥ 1 HPV Type
37, 5% 0, 0% 39, 9% 16, 3% - 13, 7%
Composite Endpoint §
< 0; 69, 5 < 0; 60, 7 < 0; 76, 8 < 0; 48, 5 < 0; 32, 5