natgillin/translations-raw huggingface dataset:
In girls and boys receiving 2 doses at 6- or 12-month interval (+/- 1-month), persistence of antibody response was demonstrated through Month 36; depending on HPV type, 81% to 99% of girls and boys receiving 2 doses at 6-month interval and 88% to 100% of girls and boys receiving 2 doses at 12month interval were seropositive.
U djevojčica i dječaka koji su primili 2 doze u razmaku od 6 ili 12 mjeseci (+/- 1 mjesec) dokazano je trajanje odgovora protutijela tijekom 36 mjeseci; ovisno o tipu HPV-a, seropozitivno je bilo 81 do 99% djevojčica i dječaka koji su primili 2 doze u razmaku od 6 mjeseci te 88 do 100% djevojčica i dječaka koji su primili 2 doze u razmaku od 12 mjeseci.
There are no data on the use of Gardasil 9 in individuals with impaired immune responsiveness.
Nema podataka o primjeni cjepiva Gardasil 9 u osoba s narušenim imunološkim odgovorom.
• Withdraw the 0.5 ml dose of vaccine from the vial using a sterile needle and syringe.
• Izvucite dozu cjepiva od 0,5 ml iz bočice pomoću sterilne igle i štrcaljke.
In Protocol 001, GMTs for HPV-6, -11, -16 and -18 were comparable in subjects who received qHPV vaccine or Gardasil 9 for at least 3.5 years.
U Protokolu 001, geometrijski srednji titri za HPV tipove 6, 11, 16 i 18 bili su usporedivi u ispitanika koji su primili qHPV cjepivo ili Gardasil 9 tijekom najmanje 3,5 godine.
• Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and syringe.
• Izvucite dozu cjepiva od 0,5 ml iz bočice s jednom dozom pomoću sterilne igle i štrcaljke.
It is prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein from the same four HPV types (6, 11, 16, 18) in qHPV vaccine and from 5 additional HPV types (31, 33, 45, 52, 58).
Pripremljeno je od visokopročišćenih čestica nalik virusu glavnog L1 proteina kapside četiri tipa HPV-a (6, 11, 16 i 18) kakva sadrže cjepiva qHPV i 5 dodatnih tipova HPV-a (31, 33, 45, 52 i 58).
Gardasil 9 also reduced the incidence of HPV 31-, 33-, 45-, 52-, and 58-related Pap test abnormalities, cervical and external genital procedures (i.e., biopsies), and cervical definitive therapy procedures (Table 4).
Gardasil 9 je također smanjio incidenciju abnormalnih nalaza Papatesta povezanih s tipovima 31, 33, 45, 52 i 58 HPV-a, postupaka na cerviksu i vanjskim spolnim organima (tj, biopsija) i konačnih terapijskih postupaka na cerviksu (Tablica 4).
Gardasil 9 is an adjuvanted non-infectious recombinant 9-valent vaccine.
Gardasil 9 je adjuvantno neinfektivno 9-valentno rekombinantno cjepivo.
Gardasil 9 can be given with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) at a separate injection site (another part of your body, for example the other arm or leg) during the same visit.
Gardasil 9 se može primijeniti kod docjepljivanja kombiniranim cjepivom protiv difterije (d) i tetanusa (T) zajedno s cjepivom protiv hripavca [acelularno, komponento] (ap) i/ili poliomijelitisa [inaktivirano] (IPV) (dTap, dT-IPV, dTap-IPV cjepiva), ali u različito mjesto injiciranja (drugi dio tijela, na primjer u drugu ruku ili nogu), i to tijekom istog posjeta liječniku.
Comparison of Gardasil 9 with qHPV vaccine with respect to HPV types 6, 11, 16, and 18 were conducted in a population of women aged 16 to 26 years from Protocol 001, girls aged 9 to 15 years from GDS01C/Protocol 009 and men aged 16 to 26 years from GDS07C/Protocol 020.
Usporedba između cjepiva Gardasil 9 i cjepiva qHPV u pogledu tipova 6, 11, 16 i 18 HPV-a provedena je u populaciji žena u dobi od 16 do 26 godina iz Protokola 001, djevojčica u dobi od 9 do 15 godina iz GDS01C/Protokola 009 te muškaraca u dobi od 16 do 26 godina iz GDS07C/Protokola
The efficacy of Gardasil 9 in women aged 16 to 26 years was assessed in an active comparator-controlled, double-blind, randomised clinical study (Protocol 001) that included a total of 14,204 women (Gardasil 9 = 7,099; qHPV vaccine = 7,105).
Djelotvornost cjepiva Gardasil 9 u žena u dobi od 16 do 26 godina bila je ocijenjena u dvostruko slijepom, randomiziranom, kliničkom ispitivanju kontroliranom aktivnim komparatorom (Protokol 001) koje je uključilo ukupno 14 204 žena (Gardasil 9=7099; cjepivo qHPV=7105).
Do not use this vaccine after the expiry date which is stated on the carton and syringe label after EXP.
Ovo cjepivo se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici štrcaljke iza oznake "EXP".
• demonstration of non-inferior immunogenicity against the Gardasil 9 HPV types in boys and girls aged 9 to 15 years, men aged 16 to 26 years and women aged 27 to 45 years, compared to girls and women aged 16 to 26 years.
• dokazanoj neinferiornoj imunogenosti protiv tipova HPV-a u cjepivu Gardasil 9 u dječaka i djevojčica u dobi od 9 do 15 godina, muškaraca u dobi od 16 do 26 godina i žena u dobi od 27 do 45 godina, u usporedbi s djevojkama i ženama u dobi od 16 do 26 godina.
Excipients: Sodium chloride, histidine, polysorbate 80, borax, water for injections.
Pomoćne tvari: natrijev klorid, histidin, polisorbat 80, natrijev tetraborat, voda za injekcije.
The following side effects can be seen after the use of Gardasil 9:
Mogu se pojaviti sljedeće nuspojave nakon primjene cjepiva Gardasil 9:
When Gardasil 9 was given with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine during the same visit, there was more injection-site swelling.
Kad se Gardasil 9 davao kod docjepljivanja kombiniranim cjepivom protiv difterije, tetanusa, hripavca [acelularno, komponentno] i poliomijelitisa [inaktivirano] prilikom istog posjeta liječniku, bilo je više oticanja na mjestu primjene injekcije.
GMT Ratio
GMT omjer
If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.
Ako se druga doza cjepiva primijeni prije nego što je prošlo 5 mjeseci od prve doze, uvijek se mora primijeniti treća doza.
Additional efficacy evaluation of Gardasil 9 against vaccine HPV types Since the efficacy of Gardasil 9 could not be evaluated against placebo, the following exploratory analyses were conducted.
Budući da se djelotvornost cjepiva Gardasil 9 nije mogla ocijeniti u odnosu na placebo, provedene su sljedeće eksplorativne analize.
It is given to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58.
Daje se radi zaštite od bolesti uzrokovanih ljudskim papilomavirusom (HPV) tipa 6, 11, 16, 18, 31, 33, 45, 52 i 58.
Gardasil 9 does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination.
Gardasil 9 neće spriječiti lezije uzrokovane tipom HPV-a koji je sadržan u cjepivu u osoba koje su u vrijeme cijepljenja zaražene tim tipom HPV-a.
In long-term extensions of clinical studies, no cases of high-grade intraepithelial neoplasia and no cases of genital warts were observed: - through 10.7 years in girls (n=369) and 10.6 years in boys (n = 326), 9-15 years of age at time of vaccination (median follow-up of 10.0 years and 9.9 years, respectively); - through 11.5 years in men (n=917), 16-26 years of age at time of vaccination (median follow-up of 9.5 years); and through 10.1 years in women (n = 685), 24-45 years of age at time of vaccination (median follow-up of 8.7 years).
U dugotrajnim nastavcima kliničkih ispitivanja, nisu opaženi slučajevi intraepitelnih neoplazija visokog stupnja ili genitalnih bradavica: - tijekom 10,7 godina u djevojčica (n=369) i 10,6 godina u dječaka (n=326), koji su u vrijeme cijepljenja bili u dobi od 9 do 15 godina (medijan praćenja 10,0 godina u djevojčica odnosno 9,9 godina u dječaka); - tijekom 11,5 godina u muškaraca (n=917), koji su u vrijeme cijepljenja bili u dobi od 16 do 26 godina (medijan trajanja praćenja 9,5 godina) i tijekom 10,1 godine u žena (n=685) koje su u vrijeme cijepljenja bile u dobi od 24 do 45 godina (medijan trajanja praćenja 8,7 godina).
Based on epidemiology studies, Gardasil 9 is anticipated to protect against the HPV types that cause approximately: 90% of cervical cancers, more than 95% of adenocarcinoma in situ (AIS), 75-85% of high-grade cervical intraepithelial neoplasia (CIN 2/3), 85-90% of HPV related vulvar cancers, 90-95% of HPV related high-grade vulvar intraepithelial neoplasia (VIN 2/3), 80-85% of HPV related vaginal cancers, 75-85% of HPV related high-grade vaginal intraepithelial neoplasia (VaIN 2/3),
Na temelju epidemioloških ispitivanja očekuje se da će Gardasil 9 štititi protiv tipova HPV-a koji uzrokuju približno 90% raka cerviksa, više od 95% adenokarcinoma in situ (AIS); 75-85% cervikalnih intraepitelnih neoplazija visokoga stupnja (CIN 2/3); 85-90% raka vulve povezanih s HPV-om; 9095% vulvarnih intraepitelnih neoplazija visokoga stupnja povezanih s HPV-om (VIN 2/3), 80-85% raka vagine povezanih s HPV-om, 75-85% vaginalnih intraepitelnih neoplazija visokog stupnja povezanih s HPV-om (VaIN 2/3), 90-95% raka anusa povezanih s HPV-om, 85-90% analnih intraepitelnih neoplazija visokog stupnja povezanih s HPV-om (AIN 2/3) i 90% genitalnih bradavica.
As with any vaccine, vaccination with Gardasil 9 may not result in protection in all vaccine recipients.
Kao i sa bilo kojim cjepivom, cijepljenje cjepivom Gardasil 9 ne mora pružiti zaštitu svima koji su primili cjepivo.
GDS01C/Protocol 009 evaluated immunogenicity of Gardasil 9 in girls aged 9 to 15 years (N=600; 300 receiving Gardasil 9 and 300 receiving qHPV vaccine).
GDS01C/Protokol 009 ocijenio je imunogenost cjepiva Gardasil 9 u djevojčica u dobi od 9 do 15 godina (N=600; 300 je primilo Gardasil 9, a 300 je primilo cjepivo qHPV).
In 24- through 45- year-old women (N=3,817) efficacy against HPV 6, 11, 16 and 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 88.7% (95%CI: 78.1, 94.8).
U žena u dobi od 24 to 45 godina (N=3817), djelotvornost protiv perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i raka cerviksa povezanih s HPV tipovima 6, 11, 16 i 18 iznosila je 88,7% (95% CI: 78,1; 94,8).
In the pivotal study Protocol 001, the efficacy of Gardasil 9 against HPV types 31, 33, 45, 52, and 58 was evaluated compared to qHPV vaccine in women aged 16 to 26 years (N=14,204: 7,099 receiving Gardasil 9; 7,105 receiving qHPV vaccine).
U pivotalnom ispitivanju Protokol 001, djelotvornost cjepiva Gardasil 9 protiv tipova 31, 33, 45, 52 i 58 HPV-a ocijenjena je u usporedbi s cjepivom qHPV u žena u dobi od 16 do 26 godina (N=14 204: 7099 primilo je Gardasil 9; 7105 primilo je cjepivo qHPV).
• demonstration of efficacy of qHPV vaccine to prevent persistent infection and disease related to HPV types 6, 11, 16 and 18 in females aged 16 to 45 years and males aged 16 to 26 years.
• dokazanoj djelotvornosti cjepiva qHPV u sprječavanju perzistentne infekcije i bolesti povezane s tipovima 6, 11, 16 i 18 HPV-a u žena u dobi od 16 do 45 godina i muškaraca u dobi od 16 do 26 godina.
Table 1: Adverse reactions following administration of Gardasil 9 occurring with a frequency of at least 1.0% from clinical trials*
Tablica 1: Nuspojave nakon primjene cjepiva Gardasil 9 koje su se javile s učestalošću od najmanje 1,0% iz kliničkih ispitivanja* Klasifikacija organskih sustava Učestalost
Protocol 004 evaluated immunogenicity of Gardasil 9 in women aged 16 to 45 years (N=1,210: 640 women aged 27 to 45 years and 570 women aged 16 to 26 years).
Protokolu 004 ocijenjena je imunogenost cjepiva Gardasil 9 u žena u dobi od 16 do 45 godina (N=1210: 640 žena u dobi od 27 do 45 godina i 570 žena u dobi od 16 do 26 godina).
• demonstration of non-inferior immunogenicity between Gardasil 9 and the qHPV vaccine for HPV types 6, 11, 16 and 18 in girls aged 9 to 15 years, women and men aged 16 to 26 years; efficacy for Gardasil 9 against persistent infection and disease related to HPV types 6, 11, 16, or 18 can be inferred to be comparable to that of the qHPV vaccine.
• dokazanoj neinferiornoj imunogenosti između cjepiva Gardasil 9 i cjepiva qHPV protiv tipova 6, 11, 16 i 18 HPV-a u djevojčica u dobi od 9 do 15 godina, žena i muškaraca u dobi od 16 do 26 godina; posljedično se može zaključiti da je djelotvornost cjepiva Gardasil 9 protiv perzistentne infekcije i bolesti povezane s tipovima 6, 11, 16 ili 18 HPV-a usporediva s onom cjepiva qHPV.
Suspension for injection 1 vial (0.5 ml).
Suspenzija za injekciju 1 bočica (0,5 ml).
Individuals 15 years of age and older at time of first injection Gardasil 9 should be administered according to a 3-dose (0, 2, 6 months) schedule.
Pojedinci u dobi od 15 godina i stariji u vrijeme prve injekcije Gardasil 9 teba primijeniti prema rasporedu za 3 doze (0, 2, 6 mjeseci).
GDS07C/Protocol 020 evaluated immunogenicity of Gardasil 9 in men aged 16 to 26 years (N=500; 249 receiving Gardasil 9 and 251 receiving qHPV vaccine).
GDS07C/Protokol 020 ocijenio je imunogenost cjepiva Gardasil 9 u muškaraca u dobi od 16 do 26 godina (N=500; 249 je primilo Gardasil 9, a 251 je primilo cjepivo qHPV).
In a clinical trial, persistence of antibody response has been demonstrated for at least 5 years in girls aged 9 to13 years who received 2 doses of qHPV vaccine.
U kliničkom je ispitivanju dokazano da odgovor protutijela u djevojčica u dobi od 9 do 13 godina koje su primile 2 doze cjepiva qHPV traje najmanje 5 godina.
Gardasil 9 may be administered concomitantly with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) with no significant interference with antibody response to any of the components of either vaccine.
Gardasil 9 može se istodobno primijeniti kod docjepljivanja kombiniranim cjepivom koje sadrži difteriju (d) i tetanus (T) zajedno s pertusisom [acelularni, komponentni] (ap) i/ili poliomijelitisom [inaktivirani] (IPV) (dTap, dT-IPV i dTap-IPV cjepiva), pri čemu odgovor protutijela ni na jednu komponentu jednog ili drugog cjepiva neće biti značajno promijenjen.
Protocol 010 measured HPV antibody responses to the 9 HPV types after Gardasil 9 vaccination in the following cohorts: girls and boys aged 9 to 14 years receiving 2 doses at a 6-month or 12-month interval (+/- 1-month); girls aged 9 to 14 years receiving 3 doses (at 0, 2, 6 months); and women aged 16 to 26 years receiving 3 doses (at 0, 2, 6 months).
U protokolu 010 mjeren je odgovor protutijela na 9 tipova HPV-a nakon cijepljenja cjepivom Gardasil 9 u sljedećim kohortama: djevojčice i dječaci u dobi od 9 do 14 godina koji su primili 2 doze u vremenskom razmaku od 6 ili 12 mjeseci (+/- 1 mjesec); djevojčice u dobi od 9 do 14 godina koje su primile 3 doze (u 0., 2., 6. mjesecu); žene u dobi od 16 do 26 godina koje su primile 3 doze (u 0., 2., 6. mjesecu).
Protocol 006 evaluated administration of Gardasil 9 to girls and women aged 12 to 26 years previously vaccinated with qHPV vaccine (N=921; 615 receiving Gardasil 9 and 306 receiving placebo).
Protokolu 006 ocijenjena je primjena cjepiva Gardasil 9 u djevojčica i žena u dobi od 12 do 26 godina koje su prethodno bile cijepljene cjepivom qHPV (N=921; 615 je primilo Gardasil 9, a 306 je primilo placebo).
At Month 36, the GMTs in girls and boys aged 9 to 14 years receiving 2 doses at a 6-month interval (+/- 1-month) remained non-inferior to GMTs in women aged 16 to 26 years receiving 3 doses of Gardasil 9.
GMT-ovi u 36. mjesecu u djevojčica i dječaka u dobi od 9 do 14 godina koji su primili 2 doze u razmaku od 6 mjeseci (+/1 mjesec) i dalje su bili neinferiorni GMT-ovima zabilježenima u žena u dobi od 16 do 26 godina koje su primile 3 doze cjepiva Gardasil 9.
Common (may affect up to 1 in 10 people): side effects found at the injection site (bruising, and itching), fever, tiredness, dizziness and nausea.
Često (mogu se javiti u najviše 1 na 10 osoba): nuspojave zamijećene na mjestu injekcije (modrice i svrbež), vrućica, umor, omaglica i mučnina.
In Protocol 002 extension study, no cases of high-grade intraepithelial neoplasia or genital warts were observed through 6.4 years postdose 3 (median follow-up of 5.9 years) in girls (n = 753) or boys (n=227) who were aged 9 to 15 years at time of vaccination with Gardasil 9.
U nastavku ispitivanja Protokol 002, tijekom 6,4 godine nakon 3. doze (medijan praćenja 5,9 godina) nije opažen nijedan slučaj intraepitelnih neoplazija visokog stupnja ni genitalnih bradavica u djevojčica (n=753) i dječaka (n=227) koji su u vrijeme cijepljenja cjepivom Gardasil 9 bili u dobi od 9 do 15 godina.
Adsorbed on amorphous aluminium hydroxyphosphate sulfate adjuvant (0.5 milligrams Al).
20 μg adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,5 mg Al).
GMTs were higher in girls and boys who received 2 doses of Gardasil 9 (at either 0, 6 months or 0, 12 months) than in girls and women 16 to 26 years of age who received 3 doses of Gardasil 9 (at 0, 2, 6 months) for each of the 9 vaccine HPV types.
GMT-ovi su bili viši u djevojčica i dječaka koji su primili 2 doze cjepiva Gardasil 9 (bilo u 0., 6. mjesecu ili 0., 12. mjesecu) nego u djevojčica i žena u dobi od 16 do 26 godina koje su primile 3 doze cjepiva Gardasil 9 (u 0., 2., 6. mjesecu) za svaki od 9 tipova HPV-a u cjepivu.
It uses the same amorphous aluminium hydroxyphosphate sulfate adjuvant as qHPV vaccine.
U njemu se koristi isti adjuvans od amorfnog aluminijevog hidroksifosfat sulfata kao i u cjepivu qHPV.
Immunogenicity bridging from qHPV Vaccine to Gardasil 9 for HPV types 6, 11, 16, 18
Ekstenzija podataka o imunogenosti s qHPV cjepiva na Gardasil 9 za tipove 6, 11, 16, 18
Studies supporting the efficacy of Gardasil 9 against HPV types 31, 33, 45, 52, and 58
Ispitivanja koja podupiru djelotvornost cjepiva Gardasil 9 protiv tipova 31, 33, 45, 52 i 58 HPV-a
These diseases include pre-cancerous lesions and cancers of the female genitals (cervix, vulva, and vagina), pre-cancerous lesions and cancers of the anus and genital warts in males and females.
Te bolesti uključuju oštećenja koja prethode raku (prekancerozne lezije) i rak ženskih spolnih organa (vrata maternice, stidnice i rodnice); prekancerozne lezije i rak anusa i bradavice na spolovilu u muškaraca i žena.
HPV Type 11 and 18 L1 protein
HPV tip 11 i 18 L1 protein
The use of Gardasil 9 should be in accordance with official recommendations.
Gardasil 9 mora se primjenjivati sukladno službenim preporukama.
Gardasil 9 suspension for injection.
Gardasil 9 suspenzija za injekciju.
It is recommended that individuals who receive a first dose of Gardasil 9 complete the vaccination course with Gardasil 9.
Preporučuje se da osobe koje prime prvu dozu cjepiva Gardasil 9 i dovrše cijepljenje cjepivom Gardasil 9.
A statistical analysis of non-inferiority was performed at Month 7 comparing cLIA anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 GMTs between individuals administered Gardasil 9 and individuals administered Gardasil.
Statističkom analizom neinferiornosti provedenom u 7. mjesecu usporedili su se geometrijski srednji titri cLIA anti-HPV 6, anti-HPV 11, anti-HPV 16 i anti-HPV 18 u osoba kojima je bio primijenjen
• Shake the pre-filled syringe well before use, to make a suspension.
• Prije uporabe dobro protresite napunjenu štrcaljku kako bi se dobila suspenzija.
In clinical studies 99.2% to 100% who received Gardasil 9 became seropositive for antibodies against all 9 vaccine types by Month 7 across all groups tested.
U kliničkim ispitivanjima je 99,2% do 100% onih koji su primili Gardasil 9 postalo seropozitivno za protutijela na svih 9 tipova sadržanih u cjepivu do 7. mjeseca u svim testiranim skupinama.
Protocol 003 evaluated immunogenicity of Gardasil 9 in men aged 16 to 26 years and women aged 16 to 26 years (N=2,515:1,103 Heterosexual Men [HM]; 313 Men Who Have Sex with Men [MSM]; and 1,099 women receiving Gardasil 9).
Protokolu 003 ocijenjena je imunogenost cjepiva Gardasil 9 u muškaraca u dobi od 16 do 26 godina i žena u dobi od 16 do 26 godina (N=2515:1103 heteroseksualna muškarca [HM], 313 muškaraca koji imaju spolne odnose s drugim muškarcima [MSM] i 1099 žena primilo je Gardasil 9).
Type-specific immunoassays with type-specific standards were used to assess immunogenicity to each vaccine HPV type.
Za ocjenu imunogenosti na svaki od tipova HPV-a sadržanih u cjepivu koristili su se tipsko-specifični imunološki testovi s tipsko-specifičnim kriterijima.
Gardasil 9 suspension for injection:
Gardasil 9 suspenzija za injekciju:
In Protocol 020/GDS07C, anti-HPV antibody GMTs at Month 7 among boys and men (HM) aged 16 to 26 years were comparable to anti-HPV antibody GMTs among boys and men (HM) aged 16 to 26 years administered with the qHPV vaccine for HPV 6, 11, 16 and 18.
U Protokolu 020/GDS07C, GMT-ovi protutijela na HPV u 7. mjesecu u dječaka i muškaraca u dobi od 16 do 26 godina (HM) bili su usporedivi s GMT-ovima protutijela na HPV u dječaka i muškaraca u dobi od 16 do 26 godina (HM) u kojih je primijenjeno cjepivo qHPV, za tipove 6, 11, 16 i 18 HPV-a.
Gardasil 9 induced robust anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, and anti-HPV 58 responses measured at Month 7, in
Gardasil 9 izazvao je jaki odgovor anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52 i anti-HPV 58 izmjeren u 7. mjesecu, u Protokolima 001, 002, 004, 005, 007 i GDS01C/Protokol 009.
Protocol 010 evaluated the immunogenicity of 2 doses of Gardasil 9 in girls and boys aged 9 to 14 years and 3 doses of Gardasil 9 in girls aged 9 to 14 years and women aged 16 to 26 years (N=1,518; 753 girls; 451 boys and 314 women).
Protokolu 010 ocijenjena je imunogenost 2 doze cjepiva Gardasil 9 u djevojčica i dječaka u dobi od 9 do 14 godina i 3 doze cjepiva Gardasil 9 u djevojčica u dobi od 9 do 14 godina te žena u dobi od 16 do 26 godina (N = 1518; 753 djevojčica, 451 dječak i 314 žena).
How to store Gardasil 9
Kako čuvati Gardasil 9
In 16- through 26- year-old women (N=20,541) efficacy against HPV 16- and 18-related CIN2/3, AIS or cervical cancer was 98.2% (95% CI: 93.5, 99.8) based on follow-up to 4 years (median 3.6 years); efficacy against HPV 6, 11, 16 or 18-related diseases was 96.0% (95% CI: 92.3, 98.2) for CIN or AIS, 100% (95% CI: 67.2, 100) for VIN2/3, 100% (95% CI: 55.4, 100) for VaIN2/3, and 99.0% (95% CI: 96.2, 99.9) for genital warts.
Na temelju praćenja u trajanju od 4 godine (medijan trajanja praćenja 3,6 godina) u žena u dobi od 16 do 26 godina (N=20 541), djelotvornost protiv CIN-a 2/3, AIS-a ili raka cerviksa povezanih s HPV tipovima 16 i 18 iznosila je 98,2% (95% CI: 93,5; 99,8); djelotvornost protiv bolesti povezanih s HPV tipovima 6, 11, 16 ili 18 iznosila je 96,0% (95% CI: 92,3; 98,2) za CIN ili AIS, 100% (95% CI: 67,2; 100) za VIN2/3, 100% (95% CI: 55,4; 100) za VaIN2/3 i 99,0% (95% CI: 96,2; 99,9) za genitalne bradavice.
1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 2 needles each
10 napunjenih štrcaljki (0,5 ml) svaka s po 2 igle
The genotypes for the vaccine comprised of HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58 will be referred to as vaccine HPV types.
Genotipovi HPV-a koji se nalaze u cjepivu (tj. 6, 11, 16, 18, 31, 33, 45, 52 i 58) u nastavku se nazivaju tipovima HPV-a sadržanima u cjepivu.
Gardasil 9 was efficacious in preventing HPV 31-, 33-, 45-, 52-, and 58-related persistent infection and disease (Table 4).
Gardasil 9 je bio djelotvoran u sprječavanju perzistentne infekcije i bolesti povezanih s tipovima 31, 33, 45, 52 i 58 HPV-a (Tablica 4).
In Protocol 003, anti-HPV antibody GMTs at Month 7 among boys and men (HM) aged 16 to 26 years were comparable to anti-HPV antibody GMTs among girls and women aged 16 to 26 years for vaccine HPV types.
Protokolu 003, GMT-ovi protutijela na HPV u 7. mjesecu u dječaka i muškaraca u dobi od 16 do 26 godina (HM) bili su usporedivi s GMT-ovima protutijela na HPV u djevojaka i žena u dobi od 16 do 26 godina za tipove HPV-a sadržane u cjepivu.