natgillin/translations-raw huggingface dataset:
In any case, pregnancy should be avoided for three months following vaccination (see sections 4.3 and 4.4).
Vsekakor pa ženska ne sme zanositi še najmanj tri mesece po cepljenju (glejte poglavji 4. 3 in 4. 4).
It is not known whether VZV is secreted in human milk.
3 Ni znano, če se VZV izloča z materinim mlekom.
Therefore, because some viruses are secreted in human milk, caution should be exercised if ZOSTAVAX is administered to a breast-feeding woman.
Pri cepljenju doječih mater priporočamo previdnost, saj se nekateri virusi lahko izločajo z materinim mlekom.
In clinical trials, ZOSTAVAX has been evaluated for safety in more than 20000 adults.
Med kliničnimi preskušanji so varnost cepiva ZOSTAVAX vrednotili pri več kot 20. 000 odraslih osebah.
In the largest of these trials, the Shingles Prevention Study (SPS), 38546 subjects received a single dose of either the frozen formulation of ZOSTAVAX (n=19270) or placebo (n=19276) and were monitored for safety throughout the study.
Osebe so ves čas študije nadzirali z vidika varnosti.
During the study, vaccine-related serious adverse reactions were reported for 2 subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo (Goodpasture’ s syndrome, anaphylactic reaction, and polymyalgia rheumatica).
Med študijo so o resnih neželenih učinkih, ki so bile povezane s cepivom, poročali pri 2 osebah, ki sta bili cepljeni s cepivom ZOSTAVAX (poslabšanje astme in revmatična polimialgija), in pri 3 osebah, ki so prejele placebo (Goodpasterjev sindrom, anafilaktična reakcija in revmatična polimialgija).
In the Adverse Event Monitoring Substudy, a subgroup of individuals from the SPS (n=3345 received ZOSTAVAX and n=3271 received placebo) were provided vaccination report cards to record adverse reactions occurring from Days 0 to 42 postvaccination in addition to undergoing routine safety monitoring throughout the study.
Med celotno študijo so jih tudi rutinsko nadzirali z vidika varnosti.
The following vaccine-related injection-site and systemic adverse reactions were reported at a significantly greater incidence in the vaccine group versus the placebo group in the Adverse Event Monitoring Substudy.
V podštudiji spremljanja neželenih dogodkov so poročali, da je bila pojavnost teh na mesto aplikacije cepiva vezanih in sistemskih neželenih učinkov pomembno večja v skupini, ki je prejela cepivo, kot pa v skupini, ki je prejela placebo.
Most of these adverse reactions were reported as mild in intensity.
Večina reakcij je bila blagih.
Several adverse reactions were solicited (Days 0-4 postvaccination) and are designated with the * symbol.
Večina neželenih učinkov se je pojavilo skupaj (v času od 0. dneva do 4. dneva po cepljenju) in so označene z *.
[Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1000, < 1/ 100); Rare (≥ 1/ 10,000, < 1/ 1,000); Very rare (< 1/ 10,000) including isolated cases]
[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]
Nervous system disorder Common: headache
Bolezni živčevja Pogosti: glavobol
General disorders and administration site conditions Very common: erythema, * pain/ tenderness, * swelling* Common: haematoma, pruritus, warmth
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: eritem, * bolečina/ občutljivost, * oteklina * Pogosti: hematom, srbenje, toplota
The overall incidence of vaccine-related injection-site adverse reactions was significantly greater for subjects vaccinated with ZOSTAVAX versus subjects who received placebo (48% for ZOSTAVAX and 17% for placebo).
Celotna pojavnost na mesto aplikacije cepiva vezanih neželenih učinkov je bila pri osebah, ki so bile cepljene s cepivom ZOSTAVAX, pomembno večja kot pri osebah, ki so prejele placebo (48% za cepivo ZOSTAVAX in 17% za placebo).
4 The remainder of subjects in the SPS received routine safety monitoring, but were not provided report cards.
Ostale osebe, vključene v SPS, so bile rutinsko nadzorovane z vidika varnosti, niso pa prejele kartončkov za poročanje.
The types of events reported in these patients were generally similar to the subgroup of patients in the Adverse Event Monitoring Substudy.
Dogodki, o katerih so poročali pri teh osebah, so bili na splošno podobni dogodkom pri osebah v podštudiji spremljanja neželenih dogodkov.
Within the 42-day postvaccination reporting period in the SPS, the number of reported zosteriform rashes among all subjects was small (17 for ZOSTAVAX, 36 for placebo; p=0.009).
Med vsemi osebami, vključenimi v SPS, je bilo med 42- dnevnim obdobjem po cepljenju število poročil o kožnem izpuščaju, podobnemu izpuščaju pri herpesu zostru, majhno (17 za cepivo ZOSTAVAX, 36 za placebo; p = 0, 009).
Of these 53 zosteriform rashes, 41 had specimens that were available and adequate for PCR testing.
Od teh 53 kožnih izpuščajev, podobnih izpuščaju pri herpesu zostru, je bilo odvzetih 41 vzorcev, ki so bili primerni in so zadostovali za testiranje s PCR.
Wild-type VZV was detected in 25 (5 for ZOSTAVAX, 20 for placebo) of these specimens.
Divji tip VZV so odkrili v 25 vzorcih (5 za cepivo ZOSTAVAX, 20 za placebo).
The Oka/ Merck strain of VZV was not detected from any of these specimens.
Seva Oka/ Merck VZV niso odkrili v nobenem vzorcu.
Within the same 42-day postvaccination reporting period in the SPS, the number (n=59) of reported varicella-like rashes was also small.
Med 42- dnevnim obdobjem po cepljenju je bilo v SPS majhno tudi število poročil o kožnem izpuščaju, podobnemu izpuščaju pri noricah (n = 59).
Of these varicella-like rashes, 10 had specimens that were available and adequate for PCR testing.
4 pri noricah, je bilo odvzetih 10 vzorcev, ki so bili primerni in so zadostovali za testiranje s PCR.
VZV was not detected in any of these specimens.
VZV niso odkrili v nobenem vzorcu.
In other clinical trials in support of the initial licensure of the frozen formulation of ZOSTAVAX, the reported rates of noninjection-site zosteriform and varicella-like rashes within 42 days postvaccination were also low in both zoster vaccine recipients and placebo recipients.
V ostalih kliničnih preskušanjih v podporo prvotnemu dovoljenju za promet za zamrznjeno obliko cepiva ZOSTAVAX so med 42- dnevnim obdobjem po cepljenju prejemnikov cepiva ZOSTAVAX, kot tudi prejemnikov placeba, poročali tudi o majhnem odstotku pojava kožnega izpuščaja, podobnega izpuščaju pri herpesu zostru ali noricah, in sicer na mestih kamor cepivo ni bilo aplicirano.
Of the 17 reported noninjection-site zosteriform and varicella-like rashes, 10 specimens were available and adequate for PCR testing.
Od 17 primerov pojava kožnega izpuščaja, podobnega izpuščaju pri herpesu zostru ali noricah, ki se je pojavil na mestih, kamor cepivo ni bilo aplicirano, je bilo odvzetih 10 vzorcev, ki so bili primerni in so zadostovali za testiranje s PCR.
The Oka/ Merck strain was identified by PCR analysis from the lesion specimens of only two subjects who reported varicella-like rashes (onset on Day 8 and 17).
Sev Oka/ Merck je bil z metodo PCR odkrit le v vzorcih, ki sta bila odvzeta pri dveh osebah s kožnim izpuščajem, podobnim izpuščaju pri noricah (pojavila sta se 8. oziroma 17. dan).
In other clinical trials evaluating ZOSTAVAX in subjects 50 years of age or older, including a study of concomitantly administered inactivated influenza vaccine, the safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS.
V ostalih kliničnih preskušanjih cepiva ZOSTAVAX pri osebah, starih 50 let in več, vključno s študijo o sočasni uporabi cepiv proti gripi z inaktiviranimi virusi, je bil varnostni profil v splošnem podoben varnostnemu profilu v podštudiji spremljanja neželenih učinkov, ki je bila izvedena v okviru SPS.
However, in these trials, a higher rate of injection-site adverse experiences of mild-to-moderate intensity was reported among subjects 50-59 years of age compared with subjects ≥ 60 years of age (see section 5.1).
V teh preskušanjih pa so pri osebah, starih od 50 do 59 let, poročali o večjem odstotku blagih do zmernih neželenih učinkov, vezanih na mesto aplikacije, kot pa pri osebah, starih 60 let ali več (glejte poglavje 5. 1).
Data from a clinical trial (n=368) demonstrated that the current refrigerated formulation is generally well tolerated with a safety profile comparable to that of the frozen formulation.
Podatki iz kliničnega preizkušanja (n=368) kažejo, da se sedanja oblika, ki se shranjuje v hladilniku, v splošnem dobro prenaša in da ima varnostni profil, ki je primerljiv s tistim za zamrznjeno obliko.
In a double-blind, placebo-controlled, randomized clinical trial, in which ZOSTAVAX was administered to 100 subjects 50 years of age or older with a history of herpes zoster (HZ) prior to vaccination, the safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS.
V dvojno slepem, s placebom nadzorovanem, randomiziranem kliničnem preskušanju, v katerem je cepivo ZOSTAVAX prejelo 100 oseb, starih 50 let ali več, z anamnezo o herpesu zostru (HZ) pred cepljenjem, je bil varnostni profil v splošnem podoben varnostnemu profilu v podštudiji spremljanja neželenih učinkov, ki je bila izvedena v okviru SPS.
Based on limited data from 2 clinical trials that enrolled VZV-seronegative or low seropositive subjects (27 subjects 30 years of age or older received live attenuated zoster vaccine), injection site and systemic adverse experiences were generally similar to those reported by other subjects who received ZOSTAVAX in clinical trials, with 2 of the 27 subjects reporting fever.
Na podlagi maloštevilnih podatkov iz 2 kliničnih preskušanj, ki sta vključevali VZV- seronegativne osebe ali osebe z nizko VZV- seropozitivnostjo (27 oseb, starih 30 let ali več, je prejelo živo, atenuirano cepivo proti herpesu zostru) so bili mesto injiciranja in sistemski neželeni učinki na splošno podobni tistim, o katerih so poročali pri drugih osebah, ki so prejele cepivo ZOSTAVAX v kliničnih preskušanjih, pri čemer so pri dveh od 27 osebah poročali o zvišani telesni temperaturi.
During post-marketing experience, the following additional adverse events have been reported spontaneously:
Neželeni učinki, o katerih so spontano poročali v času trženja zdravila:
General disorders and administration site conditions: pyrexia Immune system disorders: hypersensitivity reactions including anaphylactic reactions Skin and subcutaneous tissue disorders: rash
Bolezni kože in podkožja: izpuščaj.
Viral Vaccine; ATC code:
Virusna cepiva, oznaka ATC:
Mechanism of Action Anyone who has been infected with VZV, including those without a clinical history of varicella, is at risk for developing zoster.
Mehanizem delovanja Tveganje za pojav herpesa zostra obstaja pri vseh osebah, ki so bile okužene z VZV, tudi tistih brez klinične oblike noric v anamnezi.
This risk appears to be causally related to a decline in VZV-specific immunity.
Tveganje je domnevno vzročno povezano s slablenjem imunosti,
(See Immunogenicity.)
Dokazano je bilo, da cepivo ZOSTAVAX poživi imunost, specifično za VZV, kar je domnevno mehanizem, s katerim ščiti pred herpesom zostrom in njegovimi komplikacijami (glejte Imunogenost).
Evaluation of Clinical Efficacy Afforded by ZOSTAVAX ZOSTAVAX significantly reduced the risk of developing zoster and PHN compared with placebo.
Vrednotenje klinične učinkovitosti cepiva ZOSTAVAX V primerjavi s placebom cepivo ZOSTAVAX pomembno zmanjša tveganje za pojav herpesa zostra in PHN.
In addition, ZOSTAVAX significantly reduced zoster-associated pain as measured by the HZ pain Burden of Illness (BOI) score (see results and definition in Table 1).
HZ pain Burden of Illness (BOI) (glejte rezultate in definicijo v tabeli 1).
Table 1 Efficacy of ZOSTAVAX Compared with Placebo in the Shingles Prevention Study
Preglednica 1 Učinkovitost cepiva ZOSTAVAX v primerjavi s placebom Študija preprečevanja pasovca
Vaccine
Učinkovitost
Endpoint Incidence of Zoster Incidence of PHN** HZ Pain BOI***
Opazovani dogodek Pojavnost herpesa zostra Pojavnost PHN ** HZ Pain BOI ***
efficacy* 51% 67% 61%
cepiva * 51% 67% 61%
95% CI 44 to 58% 48 to 79% 51 to 69%
95- odstotni IZ 44 do 58% 48 do 79% 51 do 69%
*Vaccine efficacy = relative reduction in the endpoint measurement in the vaccine group compared with the placebo group **Clinically significant zoster-associated pain persisting or appearing at least 90 days after the onset of rash. ***The HZ pain BOI score is a composite score that incorporates the incidence, severity, and duration of acute and chronic zoster-associated pain over a 6-month follow-up period.
* Učinkovitost cepiva = relativno zmanjšanje opazovanega dogodka v skupini, ki je prejela cepivo, v primerjavi s skupino, ki je prejela placebo. ** Klinično pomembna bolečina, povezana s herpesom zostrom, ki traja ali se pojavi vsaj 90 dni po pojavu kožnega izpuščaja. *** Rezultat HZ pain BOI je sestavljeni rezultat, ki obsega pojavnost, intenziteto in trajanje akutne in kronične bolečine, povezane s herpes zostrom, v 6- mesečnem obdobju spremljanja.
In the Shingles Prevention Study (SPS), a placebo-controlled, double-blind clinical trial of ZOSTAVAX, 38546 subjects 60 years of age or older were randomized to receive a single dose of either ZOSTAVAX (n=19270) or placebo (n=19276).
V študiji preprečevanja pasovca (SPS), s placebom nadzorovanim, dvojno slepim kliničnim preskušanjem cepiva ZOSTAVAX, je bilo 38. 546 oseb, starih 60 let ali več, izbranih naključno tako, da so bodisi prejele enkraten odmerek cepiva ZOSTAVAX (n = 19. 270) ali placeba (n = 19. 276).
642 cases [11.1/ 1000 person-years], respectively; p < 0.001).
Cepivo ZOSTAVAX je pomembno zmanjšalo pojavnost herpesa zostra v primerjavi s placebom (315 primerov [5, 4/ 1. 000 oseb- let] v primerjavi s 642 primeri [11, 1/ 1. 000 oseb- let]; p < 0, 001).
The protective efficacy of ZOSTAVAX against zoster was 51% (95% CI:
Učinkovitost zaščite cepiva ZOSTAVAX pred herpesom zostrom je bila 51- odstotna (95- odstotni IZ:
[44 to 58%]).
[44 do 58%]).
ZOSTAVAX reduced the incidence of zoster by 64% (95% CI:
Cepivo ZOSTAVAX je zmanjšalo pojavnost herpesa zostra za 64% (95- odstotni IZ:
[56 to 71%]) in individuals 60-69 years of age and by 38% (95% CI:
[56 do 71%]) pri osebah, starih od 60 do 69 let in za 38% (95- odstotni IZ:
[25 to 48%]) in individuals ≥ 70 years of age.
[25 do 48%]) pri osebah, starih 70 let ali več.
In the SPS, the reduction in zoster was seen in almost all dermatomes.
V SPS so opazili zmanjšanje herpesa zostra na skoraj vseh dermatomih.
69 subjects who received placebo.
Herpes zoster ophthalmicus se je pojavil pri 35 osebah, ki so bile cepljene s cepivom ZOSTAVAX, in 69 osebah, ki so prejele placebo.
9 who received placebo.
Do okvare vida je prišlo pri 2 osebah, ki sta bili cepljeni s cepivom ZOSTAVAX, in 9 osebah, ki so prejele placebo.
80 cases [1.4/ 1000 person-years], respectively; p < 0.001).
Cepivo ZOSTAVAX je zmanjšalo pojavnost PHN v primerjavi s placebom [(27 primerov [0, 5/ 1. 000 oseb- let] v primerjavi z 80 primeri [1, 4/ 1. 000 oseb- let]; p < 0, 001).
In this trial, the definition of PHN was clinically significant zoster-associated pain persisting or appearing at least 90 days after the onset of rash.
V tem preskušanju je bila PHN definirana kot klinično pomembna bolečina, povezana s herpesom zostrom, ki je trajala ali se je pojavila vsaj 90 dni po pojavu kožnega izpuščaja.
The protective efficacy of ZOSTAVAX against PHN was 67% (95% CI:
Učinkovitost zaščite cepiva ZOSTAVAX pred PHN je bila 67- odstotna (95- odstotni IZ:
[48 to 79%]).
[48 do 79%]).
Referring only to subjects who developed zoster, there was a decrease in the risk of subsequently developing PHN.
Upoštevajoč samo osebe, pri katerih se je pojavil herpes zoster, se je tveganje za poznejši pojav PHN zmanjšalo.
In the vaccine group, the risk of developing PHN after zoster was 9% (27/ 315), while in the placebo group it was 13% (80/ 642).
V skupini, ki je dobila cepivo, je bilo tveganje za pojav PHN po herpesu zostru 9% (27/ 315), v skupini, ki je dobila placebo, pa 13% (80/ 642).
19% for the placebo group.
Ta učinek je bil izrazitejši pri starejših osebah (≥ 70 let), kjer se je tveganje za pojav PHN po herpesu zostru v skupini, ki je dobila cepivo, zmanjšalo na 10%, v skupini na placebu pa na 19%.
ZOSTAVAX reduced the HZ pain BOI score by approximately 61% (95% CI:
Cepivo ZOSTAVAX je zmanjšalo rezultat HZ pain BOI za približno 61% (95- odstotni IZ:
[51 to 69%]), compared with placebo.
[51 do 69%]) v primerjavi s placebom.
The effect was more pronounced in the younger age group (60 to 69 years) where the efficacy of ZOSTAVAX on HZ pain BOI was 66% compared to 55% in patients ≥ 70 years of age; however, this difference was not statistically significant (p=0.266).
Vendar pa ta razlika ni bila statistično pomembna (p = 0, 266).
Prevention of HZ cases with severe pain in the entire study population ZOSTAVAX reduced the incidence of zoster with severe and long-lasting pain (severity-by-duration score > 600) by 73% (95% CI:
6 Preprečevanje primerov herpesa zostra s hudo bolečino v celotni populaciji, vključeni v študijo V primerjavi s placebom je cepivo ZOSTAVAX zmanjšalo pojavnost (11 v primerjavi s 40 primeri) herpesa zostra s hudo in dolgotrajno bolečino (rezultat intenziteta- trajanje > 600) za 73% (95- odstotni IZ:
[46 to 87%]) compared with placebo (11 vs.
[46 do 87%]).
Reduction of zoster pain severity-by-duration in vaccinated individuals who developed zoster With regard to the acute pain (pain between 0-30 days) there was no statistically significant difference between the vaccine group and the placebo group.
Zmanjšanje intenzitete- trajanja bolečine zaradi herpesa zostra pri cepljenih osebah, pri katerih se je pojavil herpes zoster Za akutno bolečino (bolečina 0- 30 dni) ni bilo statistično pomembne razlike med skupino, ki je dobila cepivo, in skupino na placebu.
The HZ pain severity-by-duration score was 89 (95%CI:
Rezultat HZ bolečina intenziteta- trajanje je bil 89 (95- odstotni IZ:
92 (95% CI:
[82 do 97%] za skupino, ki je dobila cepivo, za skupino, ki je dobila placebo pa 92 (95- odstotni IZ:
[87 to 97%]) for the placebo group.
[87 do 97%].
The overall use of analgesic medication was similar in both study groups.
Skupna poraba analgetikov je bila v obeh skupinah podobna.
Among vaccinated individuals who developed PHN, ZOSTAVAX significantly reduced PHN-associated (chronic) pain compared with placebo.
Med cepljenimi osebami, pri katerih se je pojavila PHN, je cepivo ZOSTAVAX pomembno zmanjšalo s PHN povezano (kronično) bolečino v primerjavi s placebom.
In the period from 90 days after rash onset to the end of follow-up, there was a 57% reduction in the severity-by-duration score (average scores of 347 for ZOSTAVAX and 805 for placebo; p=0.016).
V obdobju od 90 dni po pojavu izpuščaja do konca obdobja spremljanja se je rezultat jakost- trajanje zmanjšal za 57% (srednji rezultat 347 za cepivo ZOSTAVAX in 805 za placebo; p = 0, 016).
Among vaccinated individuals who developed zoster, ZOSTAVAX significantly reduced overall acute and chronic zoster-associated pain compared with placebo.
Med cepljenimi osebami, pri katerih se je pojavil herpes zoster, je cepivo ZOSTAVAX pomembno zmanjšalo skupno akutno in kronično bolečino, povezano s herpesom zostrom, v primerjavi s placebom.
[7 to 74%]) reduction (from 6.2% to 3.5%) in the risk of having HZ with severe and long-lasting pain (severity-by-duration score of > 600).
[7 do 74%]).
Immunogenicity of ZOSTAVAX Within the Shingles Prevention Study (SPS), immune responses to vaccination were evaluated in a subset of the enrolled subjects (N=1395).
Shingles Prevention Study (SPS) so imunski odziv na cepljenje vrednotili pri podskupini vključenih oseb (N = 1. 395).
ZOSTAVAX elicited higher VZV-specific immune responses at 6 weeks postvaccination compared with placebo.
Cepivo ZOSTAVAX je v 6 tednih po cepljenju sprožilo višji imunski odziv, specifičen za VZV, v primerjavi s placebom.
Increases in both VZV antibody level, measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) (1.7-fold difference, geometric mean titer [GMT] of 479 vs.
Dokazali so, da se je povečala tako raven protiteles proti VZV, določena z gpELISA (glycoprotein enzyme- linked immunosorbent assay) (1, 7 - kratna razlika, geometrični srednji titer [GMT] 479 oz.
288 gpELISA units/ ml, p < 0.001), and T-cell activity, measured by VZV interferon- gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay (2.2-fold difference, geometric mean count [GMC] of 70 vs.
288 gpELISA enot/ ml, p < 0, 001), kot aktivnost T- celic, določena s testom IFN- γ ELISPOT (VZV interferon- gamma enzyme- linked immunospot assay) (2, 2- kratna razlika, geometrično srednje število [GMC] 70 oz.
32 spot-forming cells per million peripheral blood mononuclear cells [SFC/ 106 PBMCs], p < 0.001) were demonstrated.
32 celic, ki tvorijo lise na milijon mononuklearnih celic iz periferne krvi [SFC/ 106 PBMCs], p < 0, 001).
When evaluated at 4 weeks postvaccination, the immunogenicity of the current refrigerator-stable formulation was shown to be similar to the immunogenicity of the earlier frozen formulation of ZOSTAVAX.
Štiri tedne po cepljenju se je pokazalo, da je imunogenost sedanje, v hladilniku stabilne oblike, podobna imunogenosti predhodne zamrznjene oblike cepiva ZOSTAVAX.
614 gpELISA units/ ml, respectively).
V sestavljenih analizah dveh kliničnih preskušanj, kjer so ocenjevali imunski odziv na cepivo ZOSTAVAX 4 tedne po cepljenju, so bili odzivi na splošno podobni tako pri skupini od 50- 59 let (N=389), kot pri skupini ≥60 let (N=731) (geometrični srednji titer [GMT] 668 oziroma 614 gpELISA enot/ ml).
The geometric mean fold- rise of immune response following vaccination as measured by gpELISA was 2.6-fold (95% CI:
Geometrična srednja rast imunskega odziva po cepljenju, določena z gpELISA, se je povečala za 2, 6- krat (95- odstotni IZ:
[2.4 to 2.9]) in subjects 50 to 59 years of age and 2.3-fold (95% CI:
[2, 4 do 2, 9]) pri bolnikih od 50 do 59 let in za 2, 3- krat (95- odstotni IZ:
[2.1 to 2.4]) in subjects ≥ 60 years age.
[2, 1 do 2, 4]) pri bolnikih ≥60 let.
Immunogenicity following concomitant administration In a double-blind, controlled clinical trial, 762 adults 50 years of age and older were randomized to receive a single dose of ZOSTAVAX administered either concomitantly (N=382) or nonconcomitantly (N=380) with inactivated split influenza vaccine.
Imunogenost po sočasni uporabi V dvojno slepem, nadzorovanem kliničnem preskušanju so 762 odraslih, starih 50 let in več, randomizirali tako, da so prejeli enkraten odmerek cepiva ZOSTAVAX in cepivo proti gripi sočasno (N=382) ali ne (N=380).
The antibody responses to both vaccines at 4 weeks postvaccination were similar, whether administered concomitantly or nonconcomitantly.
Odziv protiteles na obe cepivi v obdobju 4- ih tednov po cepljenju je bil, ne glede na sočasno uporabo ali ne, podoben.
7 Immunogenicity in subjects with a history of herpes zoster (HZ) prior to vaccination In a double-blind, placebo-controlled, randomized clinical trial, ZOSTAVAX was administered to 100 subjects 50 years of age or older with a history of herpes zoster (HZ) prior to vaccination to assess immunogenicity and safety (see section 4.8) of ZOSTAVAX.
Imunogenost pri osebah z anamnezo o herpesu zostru (HZ) pred cepljenjem Za oceno imunogenosti in varnosti cepiva ZOSTAVAX so v dvojno slepem, s placebom nadzorovanem, randomiziranem kliničnem preskušanju s cepivom ZOSTAVAX cepili 100 oseb, starih 50 let ali več, z anamnezo o herpesu zostru pred cepljenjem (glejte poglavje 4. 8).
ZOSTAVAX induced a significantly higher VZV-specific immune response measured by gpELISA at 4 weeks postvaccination, compared with placebo (2.1-fold difference (95% CI:
Cepivo ZOSTAVAX je v primerjavi s placebom sprožilo pomembno večji imunski odziv, specifičen za VZV, merjen z gpELISA 4 tedne po cepljenju (2, 1- kratna razlika (95- odstotni IZ:
393 gpELISA units/ ml).
[1, 5 do 2, 9]), p < 0, 001, GMT 812 v primerjavi s 393 gpELISA enot/ ml).