natgillin/translations-raw huggingface dataset:
Ervebo might not work as well if you get blood or blood products 3 months before or up to 1 month after vaccination.
Cepivo Ervebo namreč morda ne bo delovalo enako dobro, če dobite kri ali krvne izdelke v 3 mesecih pred cepljenjem ali do 1 mesec po cepljenju.
The vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding or bruising may occur following an intramuscular administration in these individuals.
Cepivo je treba previdno dajati osebam s trombocitopenijo ali kakršno koli drugo motnjo strjevanja krvi, ker se lahko pri takšnih osebah po intramuskularnem injiciranju pojavijo krvavitev ali podplutbe.
In view of the declared Public Health Emergency of International Concern and in order to ensure early supply this medicinal product is subject to a time-limited exemption allowing reliance on batch control testing conducted in the registered site(s) that are located in a third country.
Zaradi razglasitve izrednih razmer mednarodnih razsežnosti na področju javnega zdravja in za zagotovitev zgodnje preskrbe je za to zdravilo na podlagi časovno omejene izjeme dovoljeno priznavanje kontrolnega testiranja serij, opravljenega na odobrenem (odobrenih) mestu (mestih) v tretji državi.
The final primary analysis was to assess efficacy against laboratory confirmed EVD by comparing incidence of cases occurring 10 to 31 days post-randomization for those vaccinated in the immediate vaccination rings versus incidence of cases for subjects who consented on Day 0 in the delayed vaccination rings.
Namen primarne analize je bila ocena učinkovitosti proti laboratorijsko potrjeni eboli s primerjavo pojavnosti primerov, ki so se pojavili od 10 do 31 dni po randomizaciji med osebami v krogih takojšnjega cepljenja, s pojavnostjo primerov med osebami, na dan 0 vključenimi v kroge odloženega cepljenja.
Placebo Group
Skupina s placebom
SOLUTION FOR INJECTION IN VIAL - PACK OF 10
RAZTOPINA ZA INJICIRANJE V VIALI - PAKIRANJA PO 10
The median duration of arthritis across clinical trials in which arthritis was reported ranged from 2 days to 81.5 days (including duration of recurrent arthritis) with a maximum of 330 days.
Mediano trajanje artritisa je bilo v tistih kliničnih preskušanjih, v katerih so o njem poročali, od 2 dni do 81,5 dneva (vključno s trajanjem ponovljenega artritisa) in največ 330 dni.
• Use of PPE (to block splashes or other contact with infected materials)
• uporabo opreme za osebno zaščito (za preprečitev obrizganja in drugih stikov z okuženim materialom)
Immunogenicity testing has been performed in Protocol 009, Protocol 011 and Protocol 012, and includes the assessment of binding immunoglobulin G (IgG) specific to purified Kikwit ZEBOV GP by validated enzyme linked immunosorbent assay (GP-ELISA) as well as validated neutralization of vaccine virus by a plaque reduction neutralization test (PRNT).
Testiranje imunogenosti so izvedli v Protokolu 009, Protokolu 011 in Protokolu 012; to testiranje vključuje oceno vezave imunoglobulina G (IgG), specifičnega za prečiščeni Kikwit ZEBOV GP, z validiranim encimskoimunskim testom (GP-ELISA) in validirano nevtralizacijo cepilnega virusa s testom PRNT (plaque reduction neutralization test).
Vaccination with Ervebo may not result in protection in all vaccinees.
Cepljenje s cepivom Ervebo morda ne bo zaščitilo vseh cepljenih oseb.
If breakage/spillage were to occur, disinfectants such as aldehydes, alcohols and detergents are proven to reduce viral infection potential after only a few minutes.
Če se viala razbije ali se cepivo polije, je dokazano, da dezinfekcijska sredstva (kot so aldehidi, alkoholi in detergenti) že po samo nekaj minutah zmanjšajo virusni infekcijski potencial.
Pack size of 10 vials.
Velikost pakiranja z 10 vialami.
The active substance is a living Vesicular Stomatitis Virus.
Učinkovina je živ virus vezikularnega stomatitisa.
Your healthcare worker may recommend that you receive this vaccine in an emergency involving the spread of Ebola virus disease.
Zdravstveni delavec vam bo morda svetoval, da prejmete to cepivo v nujnih razmerah širjenja ebole.
As shown in Tables 2 and 3, the geometric mean titers (GMT) of GP-ELISA and PRNT increased from pre-vaccination to post-vaccination.
Kot prikazujeta preglednici 2 in 3, so se geometrični srednji titri (GMT - geometric mean titers) GPELISA in PRNT po cepljenju povečali v primerjavi z vrednostmi pred cepljenjem.
As a precautionary measure, it is preferable to avoid the use of Ervebo in individuals with known immunocompromised conditions or receiving immunosuppressive therapy, including the following conditions:
Zaradi previdnosti se je uporabi cepiva Ervebo najbolje izogniti pri osebah z znano imunsko oslabelostjo ali osebah, ki prejemajo imunosupresivno zdravljenje, vključno z naslednjimi stanji:
If you have any further questions on the use of this vaccine, ask your healthcare worker.
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravstvenim delavcem.
When in close contact (within 1 metre) of patients with Ebola Virus Disease, healthcare workers should wear face protection (a face shield or a medical mask and goggles), a clean, non-sterile long-sleeved gown, and gloves (sterile gloves for some procedures).
Zdravstveni delavci, ki so v tesnem stiku (znotraj 1 metra) z bolniki z ebolo, morajo nositi zaščito za obraz (obrazni ščitnik ali medicinsko masko in očala), čisto, nesterilno obleko z dolgimi rokavi in rokavice (sterilne rokavice za nekatere postopke).
Protocols 009 and 011 used gamma irradiation of specimens to reduce risk of wild-type Ebola virus infection of laboratory workers
V protokolih 009 in 011 je bilo uporabljeno obsevanje vzorcev z žarki gama za zmanjšanje tveganja okužbe laboratorijskih delavcev z divjim tipom virusa Ebola.
• Safe injection practices
• varne postopke injiciranja
• Ervebo is available in a pack of 10 vials.
• Cepivo Ervebo je na voljo v pakiranjih, ki vsebujejo po 10 vial.
• someone who has a weak immune system.
• osebo, ki ima šibek imunski sistem.
The presence of a minor infection should not result in deferral of vaccination.
Prisotna blaga okužba ne sme biti vzrok za odložitev cepljenja.
The vaccine will not prevent disease caused by Filoviruses other than Zaire Ebola virus.
To cepivo ne prepreči bolezni, ki jih povzročajo drugi filovirusi in ne virus Ebola Zaire.
The need for a booster dose has not been established.
Potreba po obnovitvenem odmerku ni ugotovljena.
See description of selected adverse reactions.
Glejte opis izbranih neželenih učinkov.
• Diseases of the blood such as leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems.
• Krvne bolezni, na primer levkemija, katera koli vrsta limfoma ali druge maligne novotvorbe, ki vplivajo na krvotvorni in limfatični sistem.
Do not use alcohol-based hand sanitiser when hands are soiled with dirt, blood, or other body fluids.
Ne uporabljajte sredstev za čiščenje rok na osnovi alkohola, če so roke onesnažene z umazanijo, krvjo ali drugimi telesnimi tekočinami.
In this trial, 8,673 adult subjects were enrolled and 8,651 with valid consents randomized to immediate (within 7 days of enrolment) or deferred (18 to 24 weeks after enrolment) vaccination with Ervebo.
V to preskušanje je bilo vključenih 8.673 odraslih in 8.651 z veljavnimi soglasji so randomizirali na takojšnje (v 7 dneh po vključitvi) ali odloženo (od 18 do 24 tednov po vključitvi) cepljenje s cepivom Ervebo.
This leaflet was last revised in MM/YYYY
Navodilo je bilo nazadnje revidirano dne MM. LLLL.
CI = Confidence interval; GMT = Geometric mean titer; PRNT = Plaque Reduction Neutralization Test *Protocol 011 from Month 9-12
IZ = interval zaupanja, GMT = geometrični srednji titer, PRNT = nevtralizacijski test redukcije plakov *Protokol 011 od 9. do 12. meseca
Not applicable.
ni relevantno
A decision must be made whether to discontinue breast-feeding or to abstain from Ervebo taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba ali za prenehanje dojenja ali za opustitev cepljenja s cepivom Ervebo, upoštevaje koristi dojenja za otroka in koristi cepljenja za žensko.
Clinical immunogenicity
Klinična imunogenost
Table 1: Tabulated summary of adverse reactions considered related to vaccination MedDRA-System Organ Class Adverse Reactions
Preglednica 1: Povzetek neželenih učinkov, ki veljajo za povezane s cepljenjem Organski sistem
• If you have any further questions, ask your healthcare worker.
• Če imate dodatna vprašanja, se posvetujte z zdravstvenim delavcem.
Immune globulin (IG), blood or plasma transfusions should not be given concomitantly with Ervebo.
Sočasno s cepivom Ervebo se ne sme dajati imunoglobulinov (IG) ali transfuzij krvi ali plazme.
Transmission of vaccine virus through close personal contact is accepted as a theoretical possibility.
Prenos cepilnega virusa s tesnim osebnim stikom velja kot teoretična možnost.
Vaccine administrators should counsel vaccinees to continue to protect themselves with the following measures:
Osebe, ki dajejo cepivo, morajo cepljenim osebam naročiti, naj se še naprej varujejo z naslednjimi ukrepi:
• Use soap and water when hands are soiled with dirt, blood, or other body fluids.
• Uporabljajte milo in vodo, če so roke onesnažene z umazanijo, krvjo ali drugimi telesnimi tekočinami.
Standard precautions, as outlined by WHO, include the following:
Običajni previdnostni ukrepi, kot jih navaja Svetovna zdravstvena organizacija, obsegajo:
• The vaccine is stored frozen at -80°C to -60°C and should be removed from the freezer and thawed in less than 4 hours until no visible ice is present.
• Cepivo je treba shranjevati zamrznjeno pri temperaturi od -80 do -60 °C ter ga je treba vzeti iz zmrzovalnika in odtaliti v manj kot 4 urah, dokler ni več vidnega ledu.
Women who are able to become pregnant should use an effective method of birth control.
Ženske, ki lahko zanosijo, morajo uporabljati učinkovito kontracepcijsko metodo.
This is because of a possibility that you could pass on the virus in the vaccine to the animals.
To je potrebno, ker viruse iz cepiva lahko prenesete na živali.
In 6 out of 18 subjects tested, the vaccine virus was detected in rashes (described as dermatitis, vesicles or cutaneous vasculitis lesions) suggesting a virally mediated process post-vaccination.
Pri 6 od 18 testiranih oseb so v izpuščajih (opisanih kot dermatitis, vezikli ali kožne vaskulitične lezije) našli cepilni virus; to kaže na virusno pogojeno dogajanje po cepljenju.
30938 Burgwedel Germany
30938 Burgwedel Nemčija
• Hand washing
• umivanjem rok
Solution for 1 dose in a vial (type I glass) with a stopper (chlorobutyl) and a flip-off plastic cap with aluminium seal.
Raztopina za 1 odmerek v viali (steklo tipa I) z zamaškom (klorobutil) in snemno plastično zaporko z aluminijsko zaporo.
You might have a weak immune system if:
Šibek imunski sistem imate lahko:
• Items that may have come in contact with an infected person's blood or body fluids (such as clothes, bedding, needles, and medical equipment).
• Predmetom, ki so morda bili v stiku s krvjo ali telesnimi tekočinami okužene osebe (na primer z oblačili, posteljnino, iglami in medicinsko opremo).
In this trial, 9,096 subjects ≥18 years of age who were considered CCCs of an index case with laboratory-confirmed EVD were randomized to immediate (4,539 subjects in 51 clusters) or 21 days delayed (4,557 subjects in 47 clusters) vaccination with Ervebo.
V tem preskušanju so 9.096 preiskovancev, starih ≥ 18 let, ki so bili domnevno KKK indeksnega primera z laboratorijsko potrjeno ebolo, randomizirali ali na takojšnje (4.539 preiskovancev v 51 gručah) ali za 21 dni odloženo (4.557 preiskovancev v 47 gručah) cepljenje s cepivom Ervebo.
Transmission of vaccine virus through close contact with livestock is accepted as a theoretical possibility.
Prenos cepilnega virusa s tesnim stikom z živino velja kot teoretična možnost.
However, as a precaution, vaccinees should attempt to avoid exposure of livestock to blood and bodily fluids for at least 6 weeks following vaccination to avoid the theoretical risk of spread of the vaccine virus.
Toda iz previdnosti naj se cepljene osebe poskusijo izogibati izpostavljenosti živine krvi in telesnim tekočinam vsaj 6 tednov po cepljenju, da bi preprečili teoretično tveganje za širjenje cepilnega virusa.
• If you have ever had an allergic reaction to a vaccine or medicine, talk to your healthcare worker before you receive this vaccine.
• Če se vam je kdaj pojavila alergijska reakcija na kakšno cepivo ali zdravilo, se pred cepljenjem posvetujte z zdravstvenim delavcem.
The most common injection-site adverse reactions were injection-site pain (70.3%), swelling (16.7%) and erythema (13.7%).
Najpogostejši neželeni učinki na mestu injiciranja so bili bolečina na mestu injiciranja (70,3 %), oteklost (16,7 %) in eritem (13,7 %).
No studies on the effects of Ervebo on the ability to drive and use machines have been performed.
Študij o vplivih cepiva Ervebo na sposobnost vožnje in upravljanja strojev niso izvedli.
• Pain, swelling, or redness at the injection site.
• bolečina, oteklost ali pordelost na mestu injiciranja.
Following vaccination with Ervebo, individuals may test positive for Ebola glycoprotein (GP) nucleic acids, antigens, or antibodies against Ebola GP, which are targets for certain Ebola diagnostic tests.
Osebe, cepljene s cepivom Ervebo, imajo lahko po cepljenju pozitiven izvid testa za nukleinske kisline, antigene glikoproteina (GP) Ebola ali protitelesa proti GP Ebola, na katerih temeljijo nekateri diagnostični testi za ebolo.
The MAH should provide additional qualification data for the critical reagent used in the identity test (quality control release test for AS and FP).
Imetnik dovoljenja za promet s cepivom mora predložiti dodatne podatke o kvalifikaciji ključnega reagenta, uporabljenega pri preskusu identifikacije (preskus sproščanja kontrole kakovosti za učinkovino in gotovo zdravilo).
In general, these reactions were reported within 7 days after vaccination, were mild to moderate in intensity, and had short duration (less than 1 week).
Na splošno so o teh učinkih poročali v prvih 7 dneh po cepljenju, bili so blagi do zmerni in kratkotrajni (manj kot 1 teden).
The safety profile of Ervebo in children and adolescents 6 to17 years of age was generally similar to that observed in adults.
Varnostne značilnosti cepiva Ervebo pri otrocih in mladostnikih, starih od 6 do 17 let, so bile na splošno podobne tistim, ki so jih ugotovili pri odraslih.
This trial compared Ervebo to normal saline placebo in 1,000 adults ≥18 years of age in Liberia.
V tem preskušanju so primerjali cepivo Ervebo in placebo (fizološko raztopino) pri 1.000 odraslih, starih ≥ 18 let v Liberiji.
The Per-Protocol Immunogenicity Population was the primary population for the immunogenicity analyses in Protocol 012 and includes all subjects who were compliant with the protocol, received vaccination, were seronegative at Day 1, and had a serum sample at one or more timepoints collected within an acceptable day range.
Populacija imunogenosti po-protokolu je bila primarna populacija za analize imunogenosti v Protokolu 012; obsegala je vse preiskovance, ki so upoštevali protokol, bili cepljeni, bili seronegativni 1. dan in so imeli vzorec seruma na eni ali več časovnih točkah odvzet v sprejemljivem razponu dni.
Administration of immune globulins, blood or plasma transfusions administered 3 months before or up to 1 month after Ervebo administration may interfere with the expected immune response.
Uporaba imunoglobulinov ali transfuzija krvi ali plazme v 3 mesecih pred uporabo cepiva Ervebo ali do 1 mesec po njegovi uporabi lahko zmoti pričakovani imunski odziv.
Plan to donate blood • Do not donate blood for at least 6 weeks after you receive this vaccine.
Če nameravate darovati kri • Ne darujte krvi vsaj 6 tednov po tem, ko prejmete to cepivo.
Ervebo should be administered by a trained healthcare worker.
Cepivo Ervebo mora aplicirati usposobljen zdravstveni delavec.
Ervebo is given by a healthcare worker.
Cepivo Ervebo vam bo dal zdravstveni delavec.
This vaccine might not protect everyone who receives it and the length of time you are protected from Ebola by Ervebo is not known.
Cepljenje s cepivom Ervebo morda ne bo zaščitilo vseh oseb, ki ga dobijo, in trajanje zaščite, ki vam jo cepivo Ervebo zagotavlja pred ebolo, ni znano.
The MAH should provide comprehensive comparability data confirming that the commercial product manufactured at the Burgwedel site is representative of the material used in the clinical trials.
Imetnik dovoljenja za promet s cepivom mora predložiti izčrpne primerjalne podatke, ki dokazujejo, da je zdravilo, namenjeno trženju in izdelano na lokaciji Burgwedel, reprezentativno za zdravilo, uporabljeno v kliničnih preskušanjih.
What Ervebo is and what it is used for What you need to know before you receive Ervebo How Ervebo is given
Kaj je cepivo Ervebo in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Ervebo Kako boste prejeli cepivo Ervebo Možni neželeni učinki
Baseline seropositivity, gamma irradiation of specimens to reduce risk of wild-type Ebola virus infection of laboratory workers, and other factors may impact the immune response to vaccine, which results in a higher immune response in Protocol 012.
Na imunski odziv na cepivo lahko vplivajo izhodiščna seropozitivnost, obsevanje vzorcev z žarki gama za zmanjšanje tveganja okužbe laboratorijskih delavcev z divjim tipom virusa Ebola in drugi dejavniki; rezultat tega je večji imunski odziv v Protokolu 012.
Over 93.8% of vaccine recipients met seroresponse criteria defined as a ≥2-fold increase from baseline and ≥200 EU/mL at any time post-vaccination by GPELISA and over 80.4% of subjects met seroresponse criteria defined as a ≥4-fold increase from baseline at any time post-vaccination by PRNT.
Več kot 93,8 % prejemnikov cepiva je doseglo merilo serološkega odziva, opredeljeno kot ≥ 2-kratno povečanje od izhodišča in ≥ 200 E.e./ml kadar koli po cepljenju določeno z GP-ELISA, in več kot 80,4 % preiskovancev je doseglo merilo serološkega odziva, opredeljeno kot ≥ 4-kratno povečanje od izhodišča kadar koli po cepljenju določeno s PRNT.
The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.
• pridobitvi pogojnega dovoljenja za promet z zdravilom Odbor za zdravila za uporabo v humani medicini (CHMP) po obravnavi vloge meni, da je razmerje med tveganji in koristmi ugodno, da lahko priporoči izdajo pogojnega dovoljenja za promet z zdravilom, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.
• Ervebo is a solution for injection.
• Cepivo Ervebo je raztopina za injiciranje.
Close monitoring is recommended following vaccination for the early signs of anaphylaxis or anaphylactoid reactions.
Po cepljenju je priporočljivo skrbno spremljanje glede možnih zgodnjih znakov anafilaksije ali anafilaktoidnih reakcij.
Therefore, diagnostic testing for Ebola should target non-GP sections of the Ebola virus.
Zato mora diagnostično testiranje za ebolo temeljiti na neglikoproteinskih odsekih virusa Ebola.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
Cepiva se v isti injekcijski brizgi ne sme mešati z nobenim drugim cepivom ali zdravilom.
Over 80.1% of subjects continued to meet the seroresponse criteria for GP-ELISA and over 63.5% of vaccine recipients continued to meet seroresponse criteria for PRNT at 12 months.
Po 12 mesecih je merila serološkega odziva še izpolnjevalo več kot 80,1 % preiskovancev glede na GP-ELISA in več kot 63,5 % prejemnikov cepiva glede na PRNT.
Ervebo has no or negligible influence on the ability to drive and use machines.
Cepivo Ervebo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Do not receive this vaccine at the same time that you get blood or blood products.
Če je predvideno, da boste prejeli kri ali krvne izdelke Tega cepiva ne smete dobiti ob istem času, ko dobite kri ali kakšne krvne izdelke.
One dose (1 mL): Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live attenuated) ≥72 million pfu
En odmerek (1 ml): cepivo proti virusu Ebola Zaire (rVSVΔG-ZEBOV-GP, z živimi oslabljenimi virusi) ≥ 72 milijonov pfu
In clinical trials with reports of arthritis, the median onsets were between 10 and 12 days (range from 0 to 25 days).
V kliničnih preskušanjih, kjer so poročali o artritisu, je bil mediani čas do njegovega nastopa med 10 in 12 dni (v razponu od 0 do 25 dni).
• If you have a fever (high temperature), you should talk to your healthcare worker before receiving Ervebo.
• Če imate zvišano telesno temperaturo (vročino), se posvetujte z zdravstvenim delavcem, preden prejmete cepivo Ervebo.
What Ervebo looks like and contents of the pack
Izgled cepiva Ervebo in vsebina pakiranja
Of those 9,096 subjects, 4,160 received Ervebo (2,119 subjects were vaccinated in the immediate arm and 2,041 subjects were vaccinated in the delayed arm).
Od teh 9.096 preiskovancev jih je 4.160 prejelo cepivo Ervebo (2.119 preiskovancev je bilo cepljenih v skupini s takojšnjim cepljenjem, 2.041 pa v skupini z odloženim cepljenjem).
Protocol 009 Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) was a Phase 2 randomized, double-blind, placebo-controlled trial which evaluated the safety and immunogenicity of Ebola vaccine candidates including Ervebo.
Protokol 009 PREVAIL (Partnership for Research on Ebola Vaccines in Liberia) je bilo randomizirano, dvojno slepo, s placebom nadzorovano preskušanje 2. faze, ki je ovrednotilo varnost in imunogenost kandidatnih cepiv proti eboli, vključno s cepivom Ervebo.
The vaccine should appear as a colourless to slightly brownish-yellow liquid with no particulates visible.
Cepivo mora biti brezbarvna do rahlo rjavorumena raztopina brez vidnih delcev.
All healthcare workers and other ancillary providers who have been vaccinated should not alter their practices with regard to safe injection, hygiene, and personal protective equipment (PPE) after vaccination.
Zdravstveni delavci in drugo pomožno osebje, ki so bili cepljeni, po cepljenju ne smejo spreminjati ravnanja glede varnega injiciranja, higiene in opreme za osebno zaščito.
Ervebo administered to female rats had no effects on development or behaviour of the offspring.
Cepivo Ervebo, uporabljeno pri podganjih samicah, ni vplivalo na razvoj ali vedenje potomstva.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose.
Cepivo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek.
• You can also catch Ebola from things that have touched the blood or body fluids of a person or animal with Ebola (like clothes or objects in direct contact).
• Prav tako se lahko ebole nalezete preko predmetov, ki so bili v stiku s krvjo ali telesnimi tekočinami osebe ali živali, obolele za ebolo (npr. preko oblačil ali predmetov, ki so bili v neposrednem stiku).
Vaccine administrators should counsel vaccinees to continue to protect themselves with adequate measures.
Osebe, ki dajejo cepivo, morajo cepljenim osebam naročiti, naj se še naprej varujejo z ustreznimi ukrepi.
• Ervebo should not be mixed in the same syringe with any other vaccines or medicinal products.
• Cepiva Ervebo ne smete v isti injekcijski brizgi mešati z nobenim drugim cepivom ali zdravilom.
The vaccine virus is a Genetically Modified Organism (GMO).
Cepilni virus je genetsko spremenjen organizem (GSO).
Protocol 012 was a Phase 3 randomized, double-blind, placebo-controlled trial which evaluated the safety and immunogenicity of three consistency lots and a high dose lot (approximately five times higher than the dose in consistency lots and dose used in other Phase 2/3 trials) of Ervebo compared to normal saline placebo.
Protokol 012 je bilo randomizirano, dvojno slepo, s placebom nadzorovano preskušanje 3. faze, ki je ovrednotilo varnost in imunogenost treh konsistenčnih serij (consistency lots) in serije z velikim odmerkom (približno petkrat večji odmerek od odmerka v konsistenčnih serijah in odmerka, uporabljenega v drugih preskušanjih 2./3.