natgillin/translations-raw huggingface dataset:
If you and/or your child are ill with a high fever. 
• če ste vi in/ali vaš otrok bolni in imate visoko temperaturo.
Like other intramuscular injections, this vaccine should not be administered intramuscularly to persons with thrombocytopenia, haemophilia or other bleeding disorders (see section 4.2). 
Kot druge intramuskularne injekcije, se tudi tega cepiva ne sme dati intramuskularno osebam s trombocitopenijo, hemofilijo ali drugimi motnjami v strjevanju krvi (glejte poglavje 4.2).
Challenge studies were performed in mice that were treated with human IXIARO antisera. 
Študije s povzročanjem odziva so izvedli pri miših, ki so jih zdravili s človeškim protiserumom cepiva IXIARO.
Valneva Scotland Ltd. Oakbank Park Road Livingston EH53 0TG United Kingdom 
Valneva Scotland Ltd. Oakbank Park Road, Livingston EH53 0TG Velika Britanija
The safety of Ixiaro was assessed in controlled and uncontrolled clinical studies in 5,021 healthy adults (from non-endemic countries) and 1,559 children and adolescents (mostly from endemic countries). 
Varnost cepiva IXIARO je bila ocenjena v nadzorovanih in nenadzorovanih kliničnih študijah, v katerih je sodelovalo 5.021 zdravih odraslih (iz neendemičnih držav) in 1.559 otrok in mladostnikov (večinoma iz endemičnih držav).
Long term immunogenicity of IXIARO was assessed in a subset of 181 subjects up to month 24 (Intent-to-treat (ITT) population) and in 152 subjects up to month 36 after the first IXIARO vaccination. 
Dolgotrajno imunogenost cepiva IXIARO so ocenjevali pri podskupini 181 oseb do 24 mesecev (populacija z namenom zdravljenja - ITT) in pri 152 osebah do 36 mesecev po prejetju prvega odmerka cepiva IXIARO.
Booster dose (Children and adolescents) 
Obnovitveni odmerek (otroci in mladostniki)
Day 35 Day 56 Day 365 NA= not applicable 
Dan 35 Dan 56 Dan 365 NA = ni na voljo.
However, incomplete ossification of parts of the skeleton was observed in the group receiving 2 doses, but not in the group receiving 3 doses. 
Vendar pa so v skupini, ki je prejemala dva odmerka, opazili nepopolno zakostenitev delov okostja, česar pa ni bilo v skupini, ki je prejela tri odmerke.
For adults, adolescents, children and infants aged 1 year and older a booster dose can be given within the second year (i.e. 12 - 24 months) after the first dose of the recommended primary immunization. 
Pri odraslih, mladostnikih, otrocih in dojenčkih, starih vsaj 1 leto, je mogoče dati obnovitveni odmerek v drugem letu (tj. 12-24 mesecev) po prvem odmerku priporočene primarne imunizacije.
IXIARO should be given only to adults, adolescents, children and infants aged 2 months and older travelling to countries, where JE is endemic or who are at risk through work. 
Cepivo IXIARO je treba dati samo odraslim osebam, mladostnikom, otrokom in dojenčkom, starim2 meseca ali več, ki potujejo v države, kjer je virus japonskega encefalitisa endemičen, ali ki so zaradi svojega dela izpostavljeni tveganju.
IXIARO is a white and slightly milky sterile suspension, which becomes homogenous on shaking. 
Cepivo IXIARO je bela in rahlo mlečna sterilna suspenzija, ki postane ob stresanju homogena.
There were no significant effects of age on geometric mean titer in the group receiving IXIARO. 
Pomembnega vpliva starosti na geometrični sredini titra v skupini, ki je prejemala cepivo IXIARO, ni bilo.
C. OTHER CONDITIONS OR REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports 
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Redno posodobljena poročila o varnosti zdravila (PSUR)
IXIARO should be considered for use in individuals at risk of exposure through travel or in the course of their occupation. 
O uporabi cepiva IXIARO je treba razmisliti pri posameznikih, ki tvegajo izpostavitev med potovanjem ali opravljanjem službe.
Protection against Japanese Encephalitis is not ensured until the second dose has been received. 
Zaščita pred virusom japonskega encefalitisa je zagotovljena šele po prejemu drugega odmerka cepiva.
Paediatric population No interaction studies have been performed in children and adolescents. 
Študij medsebonega delovanja pri otrocih in mladostnikih niso izvedli.
If your child is younger than 2 months of age, since IXIARO has not been tested in infants younger than 2 months of age. 
• če je vaš otrok mlajši od 2 mesecev, ker cepivo IXIARO pri dojenčkih, mlajših od 2 mesecev, ni bilo preskušeno;
The rapid schedule was tested for concomitant administration of IXIARO and Rabipur but it can also be used for administration of IXIARO alone, as no immune interference of the two vaccines has been observed (see section 4.5). 
Hitra shema je bila preizkušena za hkratno odmerjanje cepiv IXIARO in Rabipur, lahko pa jo uporabimo tudi zgolj za odmerjanje cepiva IXIARO, saj niso bile opažene nobene motnje imunskega odziva na obe cepivi (glejte poglavje 4.5).
Visit 0 (Screening) Visit 3 (Day 28) Visit 4 (Day 56) 
0. obisk (presejanje) 3. obisk (28. dan) 4. obisk (56. dan)
The safety profile of IXIARO was comparable to that of Havrix or Prevenar. 
Profil varnosti cepiva IXIARO je bil primerljiv s cepivom Havrix ali Prevenar.
Without Booster N = 150 
Brez obnovitvenega odmerka N = 150
Based on this model, it is estimated that average duration of protection will be 14 years and 75% of vaccinees will retain protective antibody levels (PRNT50≥1:10) for 10 years. 
Na osnovi tega modela je ocenjeno, da bo povprečno trajanje zaščite znašalo 14 let, 75 % cepiv pa bo ohranilo zaščitne ravni protiteles
IXIARO is injected into your or your child's upper arm muscle (deltoid muscle) by your doctor or a nurse. 
Cepivo IXIARO vam ali vašemu otroku v mišico nadlahti (deltoidna mišica) injicira zdravnik ali sestra.
If you and/or your child miss a scheduled injection, talk to your doctor and arrange another visit for the second injection. 
Če ste vi in/ali vaš otrok izpustili načrtovani odmerek cepiva, se s svojim zdravnikom dogovorite za nov obisk, da prejmete drugo injekcijo.
The mechanism of action of Japanese encephalitis (JE) vaccines is not well understood. 
Mehanizem delovanja Mehanizem delovanja cepiv proti virusu japonskega encefalitisa (JE) ni povsem poznan.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to IXIARO is negligible. 
Ni pričakovati učinkov na dojenega otroka, saj je sistemska izpostavljenost doječe ženske cepivu IXIARO
No case of overdose has been reported in the paediatric population. 
Pri pediatrični populaciji ne poročajo o primerih prevelikega odmerjanja.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to the residues protamine sulphate, formaldehyde, bovine serum albumin, host cell DNA, sodium metabisulphite (see section 2. 
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, oziroma na ostanke protaminijevega sulfata, formaldehida, govejih serumskih albuminov, DNK gostiteljske celice, natrijevega metabisulfita (glejte poglavje 2), beljakovino gostiteljske celice.
Exceptionally, IXIARO can also be administered subcutaneously to patients with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration. 
Cepivo IXIARO se lahko izjemoma injicira subkutano pri bolnikih s trombocitopenijo ali z motnjami strjevanja krvi, ker lahko po intramuskularni uporabi zdravila pride do krvavitev.
2 adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al3+) 3 Antigen Units 
2 adsorbirano na aluminijev hidroksid hidrat (približno 0,25 milligramov Al3+) 3 antigenskih enot
IXIARO will not protect against encephalitis caused by other micro-organisms. 
Cepivo IXIARO ne ščiti pred oblikami encefalitisa, ki jih povzročajo drugi mikroorganizmi.
Day 21 
Dan 21
This medicine contains potassium, less than 1mmol (39 mg) per 0.5 ml single dosage i.e. essentially ‘potassium-free' and less than 1 mmol sodium (23 mg) per 0.5 ml single dosage, that is to say essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na enkratni odmerek 0,5 ml, kar v bistvu pomeni, da je »brez kalija«, in manj kot 1 mmol (23 mg) natrija na enkratni odmerek 0,5 ml, kar v bistvu pomeni, da je »brez natrija«.
Immunogenicity of IXIARO was studied in approximately 3,119 healthy adult subjects included in seven randomized, controlled and five uncontrolled Phase 3 trials and in approximately 550 healthy children included in two randomized, controlled and two uncontrolled Phase 3 clinical trials. 
Imunogenost cepiva IXIARO je bila raziskana pri približno 3.119 zdravih odraslih, ki so sodelovali v sedmih randomiziranih nadzorovanih in petih nenadzorovanih preskušanjih 3. faze in pri približno 550 zdravih otrocih, ki so sodelovali v dveh randomiziranih nadzorovanih in dveh nenadzorovanih kliničnih preskušanjih 3. faze.
If you and/or your child get any side effects, talk to your doctor. 
• Če vi in/ali vaš otrok opazita kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
What IXIARO is and what it is used for 
Kaj je cepivo IXIARO in za kaj ga uporabljamo
In another open-label, follow-up Phase 3 study, the persistence of antibodies up to 24 months after primary vaccination was assessed. 
V drugi odprti študiji 3. faze s sledenjem so ovrednotili prisotnost protiteles do 24 mesecev po primarni imunizaciji.
The proportion of subjects that seroconverted by 7 and by 28 days after the last immunisation was similar for both schedules. 
Delež oseb, pri katerih je 7 do 28 dni po zadnji imunizaciji prišlo do serokonverzije, je bil pri obeh shemah enak.
Rates of subjects with PRNT50≥1:10 were 82.8% (95% CI: 74.9, 88.6, N=116) at Month 6 and 58.3% at Month 12 (95% CI: 49.1, 66.9, N=115). 
Odstotek oseb s PRNT50≥1:10 je znašal 82,8 % (95-odstotni IZ: 74,9, 88,6, n = 16) v 6 mesecu in 58,3 % v 12 mesecu (95-odstotni IZ: 49,1, 66,9, n = 115).
IXIARO Day 0, 28 
IXIARO, dan 0, 28
96% of subjects (64/67) still had protective antibody levels (PRNT50≥1:10), with a GMT of 148 (95%CI: 107; 207). 
Pri 96 % preiskovancev (64/67) so še vedno bile prisotne zaščitne ravni protiteles (PRNT50 ≥ 1 : 10) z geometričnim povprečnim titrom 148 (IZ 95 %: 107; 207).
Pack size of 1 syringe with or without a separate needle. 
Pakiranje vsebuje 1 injekcijsko brizgo z ločeno iglo ali brez nje.
Do not use if the blister foil is not intact or packaging is damaged. 
Ne uporabljajte, če pretisni omot ni cel ali je ovojnina poškodovana.
By Day 56, the proportion of subjects who had seroconverted was similar for both treatment groups (96.4% vs. 93.8% for IXIARO and JE VAX, respectively). 
Do 56. dne je bilo razmerje oseb, pri katerih je prišlo do serokonverzije, podobno v obeh zdravljenih skupinah (96,4 % za cepivo IXIARO v primerjavi z 93,8 % za cepivo JE-VAX).
Parents or subjects recorded adverse events on a diary card for the first seven days after each vaccination. 
Starši ali osebe so prvih sedem dni po cepljenju beležili neželene učinke na kartico dnevnika.
This vaccine has been prescribed for you and/or your child only. 
• To cepivo je bilo predpisano vam in/ali vašemu otroku osebno in ga ne smete dajati drugim.
JEV neutralizing antibodies were determined 42 days after the second dose of the primary series (Day 70). 
Nevtralizirana protitelesa proti virusu japonskega encefalitisa so bila opažena 42 dni po drugem odmerku primarne serije (dan 70).
Seroconversion rates and antibody titers also remained comparably high up to 12 months after the first immunisation in both schedules (Table 5). 
Vrednost serokonverzije in koncentracija protiteles sta ostali primerljivo visoki pri obeh shemah do 12 mesecev po prvi imunizaciji (preglednica 5).
In case you and/or your child suffer from a bleeding disorder, your doctor may decide to administer the vaccine under the skin (subcutaneously). 
V primeru motnje strjevanja krvi pri vas in/ali vašem otroku se bo vaš zdravnik morda odločil za injiciranje pod kožo (subkutano).
Store in a refrigerator Do not freeze. 
Shranjujte v hladilniku.
The second injection should be given at least 1 week before you and/or your child will be at risk of exposure to JE virus. 
Drugo injekcijo morate prejeti vsaj en teden preden boste vi in/ali vaš otrok izpostavljeni virusu japonskega encefalitisa.
Most commonly reported adverse reactions in adults included headache (20% of subjects), myalgia (13%), injection site pain (33%), injection site tenderness (33%) and fatigue (12.9%). 
Neželeni učinki, o katerih so najpogosteje poročali pri odraslih, so vključevali glavobol (20 % sodelujočih), bolečine v mišicah (13 %), bolečine na mestu injiciranja (33 %), občutljivost na mestu injiciranja (33 %) in utrujenost (12,9 %).
The immune responses elicited by IXIARO were non inferior to those induced by JE VAX (Table 2). 
Imunski odzivi, ki jih je izzvalo cepivo IXIARO niso bili slabši od tistih, ki jih je sprožilo cepivo JE-VAX (preglednica 2).
Intent-to-treat Population 
Populacija z namenom zdravljenja
Geometric mean titer (by plaque reduction neutralization test) Time point 
Geometrična sredina titra (po testu Plaque Reduction Neutralization Test) Čas
Contents of the pack and other information What IXIARO contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo IXIARO
Total Study Population Age group >65 - <75years 
Skupna populacija študije Starostna skupina od > 65 do 75 let Starostna skupina od 75. leta naprej
Children below 2 months of age 
Otroci, stari manj kot 2 meseca
Inadvertent administration of an 0.5 ml dose of IXIARO in children aged 1 to <3 years does not pose any safety concerns (section 5.1. 
0,5 ml cepiva IXIARO otrokom, starim 1 do < 3 leta ne predstavlja razloga za skrb zaradi varnosti (poglavje 5.1.
136 [n.a.] 
136 [NP]
Results indicate that the second injection of the primary immunization series can be given up to 11 months after the first dose. 
Rezultati kažejo, da lahko osebe prejmejo drugo injekcijo iz serije primarne imunizacije najkasneje 11 mesecev po prvem odmerku.
In a reproductive and pre-/post-natal toxicity study, no vaccine-related effects were detected on reproduction, foetal weight, survival and development of the off-spring. 
V študiji reproduktivne, prednatalne in postnatalne toksičnosti niso zaznali učinkov na razmnoževanje, težo ploda, preživetje in razvoj mladiča, ki bi bili povezani s cepivom.
Attach a new sterile needle prior to injection of the remaining volume. 
Pred injiciranjem preostale količine namestite novo sterilno iglo.
The SCRs and GMTs are displayed in Table 12. 
Vrednosti SKR in GMT so prikazane v preglednici 12.
Adult and older adults (>65 years) population 
Odrasli in starejši odrasli (> 65 let)
The immunogenicity of booster doses was also assessed in the study investigating persistence of immunity following different primary immunization regimens (2x6 mcg: N=116, 1x12mcg: N=116 or 1x6 mcg: N=117). 
Nezaključena primarna imunizacija (odrasli) Imunogenost obnovitvenih odmerkov so ocenili tudi v študiji, ki je raziskovala imunost po različnih primarnih imunizacijskih režimih (2 x 6 mikrogramov: n = 116, 1 x 12 mikrogramov: n = 116 ali 1 x 6 mikrogramov: n = 117).
Persons at continuous risk for acquiring Japanese encephalitis (laboratory personnel or persons residing in endemic areas) should receive a booster dose at month 12 after primary immunization (see section 5.1). 
Osebe, ki so stalno izpostavljene nevarnosti okužbe z virusom japonskega encefalitisa (laboratorijsko osebje ali osebe, ki bivajo na endemskih območjih), naj bi prejele obnovitveni odmerek 12 mesecev po primarni imunizaciji (glejte poglavje 5.1).
Geometric Mean Titer (N) 
Geometrični srednji titer (N)
If you and/or your child have developed an allergic reaction after receiving a former dose of IXIARO. 
• če se je pri vas in/ali vašem otroku po uporabi prejšnjega odmerka cepiva IXIARO pojavila alergijska reakcija.
1 dose, 0.5 ml 
1 odmerek, 0,5 ml
In adults, a second booster can be given 10 years after the first booster. 
Pri odraslih je mogoče dati drugi obnovitveni odmerek 10 let po prvem obnovitvenem odmerku.
IXIARO is a suspension for injection (0.5 ml in a glass syringe with or without a separate needle, pack size of 1). 
Cepivo IXIARO je suspenzija za injiciranje (0,5 ml v stekleni injekcijski brizgi z ločeno iglo ali brez nje,
Second dose: 28 days after first dose. 
Drugi odmerek: 28 dni po prvem odmerku.
Valneva Austria GmbH Campus Vienna Biocenter 3 A-1030 Vienna Austria 
Valneva Austria GmbH Campus Vienna Biocenter 3 A-1030 Dunaj Avstrija
What you need to know before you and/or your child receive IXIARO Do not use IXIARO: 
Kaj morate vedeti, preden boste vi ali vaš otrok prejeli cepivo IXIARO Ne uporabljajte cepiva IXIARO:
12 years< 18 years 
12 let< 18 let
Day 56 Month 7 
56. dan 7. mesec
Second dose: 7 days after first dose. 
Drugi odmerek: 7 dni po prvem odmerku.
* If you pushed the plunger stopper beyond the red line, a 0.25 ml dose is not guaranteed and a new syringe should be used. 
* Če bat potisnete čez rdečo črto, 0,25 ml odmerek ni zagotovljen, zato morate uporabiti novo injekcijsko brizgo.
*If you pushed the plunger stopper beyond the red line, a 0.25 ml dose is not guaranteed and a new syringe should be used. 
*Če bat potisnete čez rdečo črto, 0,25 ml odmerek ni zagotovljen, zato morate uporabiti novo injekcijsko brizgo.
193 [n.a.] 
193 [NP]
Seroprotection rate (SPR) defined as neutralizing antibody titer ≥1:10 and geometric mean titers (GMT) are presented in Table 11. 
Stopnja serološke zaščite (SPR), opredeljena kot titer nevtralizirajočih protiteles ≥ 1 : 10, in geometrični povprečni titri (GMT) so predstavljeni v preglednici 11.
It is unknown whether IXIARO is excreted in human milk. 
Ni znano, ali se cepivo IXIARO izloča v materino mleko.
Antibody persistence was evaluated in an uncontrolled Phase 3 follow up clinical trial, enrolling subjects who had completed two pivotal studies, and who received at least one dose of IXIARO. 
Prisotnost protiteles so ovrednotili v nekontroliranem kliničnem preskušanju 3. faze s sledenjem, v katerega so vključili osebe, ki so zaključile dve glavni študiji in ki so prejele vsaj en odmerek cepiva IXIARO.
Other medicines and IXIARO 
Druga zdravila in cepivo IXIARO
Antibody persistence and booster dose in children and adolescents from a JEV-endemic country The persistence of JEV neutralizing antibodies after primary immunisation and safety and immunogenicity of an IXIARO booster dose 12 months after primary immunization were evaluated in a randomized, controlled, open-label clinical trial conducted in the Philippines, where JEV is endemic (300 children, mean age 5.3 years, range 1.2 - 17.3 years). 
Prisotnost protiteles in obnovitveni odmerek pri otrocih in mladostnikih iz držav, kjer je virus japonskega encefalitisa endemičen Prisotnost nevtralizirajočih protiteles proti virusu japonskega encefalitisa po primarni imunizaciji ter varnost in imunogenost obnovitvenega odmerka zdravila IXIARO 12 mesecev po primarni imunizaciji so bile ocenjene v randomizirani, nadzorovani, odprti klinični raziskavi na Filipinih, kjer je virus japonskega encefalitisa endemičen (300 otrok, povprečna starost 5,3 leta, razpon 1,2-17,3 leta).
Children and adolescents from 3 years to < 18 years of age should receive a single 0.5 ml booster dose. 
Otroci in mladostniki, stari od 3 let do < 18 let, naj bi prejeli enkratni obnovitveni odmerek 0,5 ml.
6 AU (Antigen Units, corresponding to a potency of ≤ 460 ng ED50) of inactivated Japanese encephalitis virus strain SA14-14-2 (produced in Vero cells) adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al3+). 
(antigenskih enot, ki ustreza jakosti ≤ 460 ng ED50) inaktiviranega virusa japonskega encefalitisa, sev SA14-14-2 (proizvedenega v celicah Vero), adsorbiranega na aluminijev hidroksid hidrat, (približno 0,25 mg Al3+).
In people who develop severe disease, JE usually starts as a flu-like illness, with fever, chills, tiredness, headache, nausea, and vomiting. 
Pri ljudeh, ki resno zbolijo, se bolezen začne kot gripi podobna bolezen, ki ji sledijo zvišana telesna temperatura, mrzlica, utrujenost, glavobol, slabost in bruhanje.
Long-term seroprotection data following a first booster dose administered 12 - 24 months after primary immunization suggest that a second booster should be given 10 years after the first booster dose, prior to potential exposure to JEV. 
Dolgoročni podatki o serološki zaščiti po prvem obnovitvenem odmerku, danem 12-24 mesecev po primarni imunizaciji, kažejo, da je treba drugi obnovitveni odmerek dati 10 let po prvem obnovitvenem odmerku pred morebitno izpostavljenostjo virusu japonskega encefalitisa.
0.5 ml of suspension in a pre-filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer). 
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa 1) z batnim zamaškom (klorobutilni elastomer).
After immunisation with the rapid schedule a seroconversion rate of 99% has been observed 7 days after the second i.m. 
Pri imunizaciji po hitri shemi, je bila 7 dni po drugem intramuskularnem cepljenju opažena serokonverzija v višini 99 %.
GMT increased by Day 56 to 243.6 for IXIARO and to 102.0 for JE VAX, respectively. 
Vrednost geometričnega srednjega titra se je do 56. dne povečala na 243,6 za cepivo IXIARO in na 102,0 za cepivo JE-VAX.
As a precautionary measure, the use of IXIARO during pregnancy or breast-feeding should be avoided. 
Kot previdnostni ukrep se je treba uporabi cepiva IXIARO med nosečnostjo ali dojenjem izogniti.
Common: ≥ 1/100 to < 1/10 
Pogosti: ≥ 1/100 do < 1/10
In infants, the anterolateral aspect of the thigh may be used as injection site. 
Pri dojenčkih se lahko kot mesto injiciranja izbere anterolateralni del stegna.
Proportion of Subjects Achieving an ≥4-fold Increase in JEV Antibody Titers % (n/N) 
Delež oseb, ki so dosegle ≥ 4-kratno povečanje titra protiteles proti virusu japonskega encefalitisa % (n/N)
Day 0 Day 14 
Dan 0 Dan 14
If you and/or your child have experienced any health problems after previous administration of any vaccine. 
• če ste imeli vi in/ali vaš otrok pri predhodnemu cepljenju s katerim koli cepivom zdravstvene težave;
0.25 mL Booster Dose N=81 
0,25 ml obnovitvenega odmerka N = 81
Musculoskeletal and connective tissue disorders Very common: myalgia 
Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti: mialgija
However, in the absence of data and as a precautionary measure the use of IXIARO during lactation should be avoided. 
Vendar pa se je treba v odsotnosti podatkov in kot previdnostni ukrep uporabi cepiva IXIARO med dojenjem izogniti.
Rate of subjects with PRNT50≥1:10 
odstotek oseb s PRNT50≥1:10
Month 36 
36. mesec
The safety and immunogenicity of IXIARO was evaluated in an uncontrolled, open-label clinical trial conducted in the United States, Europe and Australia in healthy male and female subjects with planned travel to JEV-endemic areas. 
Varnost in imunogenost zdravila IXIARO sta bili ocenjeni v nenadzorovani, odprti klinični raziskavi v Združenih državah Amerike, Evropi in Avstraliji na zdravih prostovoljcih in prostovoljkah, ki načrtujejo potovanje na območja, kjer je virus japonskega encefalitisa endemičen.
Antibody persistence after booster immunisation (adults) In an uncontrolled, open-label extension to the booster study described above, 67 subjects were followed up for determination of JEV neutralizing antibody titres at approximately 6 years after a booster dose. 
Prisotnost protiteles po obnovitvenem cepljenju (odrasli) V nenadzorovani, odprti podaljšani študiji obnovitvenega cepljenja, opisani zgoraj, je bilo 67 preiskovancev opazovanih z namenom določitve titrov nevtralizirajočih protiteles proti virusu japonskega encefalitisa približno 6 let po obnovitvenem odmerku.
A total of 217 subjects aged 18 to ≤ 65 years received IXIARO together with inactivated rabies vaccine (Rabipur) in a rapid immunisation schedule on Day 0 and Day 7 and 56 subjects received IXIARO alone in the conventional immunisation schedule on Day 0 and Day 28. 
Skupno 217 oseb med 18. in ≤ 65. letom starosti je prejelo cepivo IXIARO skupaj z deaktiviranim cepivom proti steklini (Rabipur) po shemi hitre imunizacije, in sicer na dan 0 in dan 7, 56 oseb pa je prejelo zgolj cepivo IXIARO po shemi običajne imunizacije na dan 0 in dan 28.