natgillin/translations-raw huggingface dataset:
Antipyretic treatment should be initiated according to local treatment guidelines.
Antipiretično zdravljenje je potrebno začeti v skladu z lokalnimi smernicami zdravljenja.
If your child misses an injection
Če otrok zamudi eno injekcijo
Adverse reactions (for all age groups)have been categorised by frequency.
Neželene učinke (za vse starostne skupine) so razvrstili po pogostnosti.
In addition, OPA GMTs were in same ranges for both groups.
Poleg tega je bila GMT OPA v obeh skupinah v enakem razponu.
• You will be told when your child should come back for the next injections.
• Zdravnik vam bo povedal, kdaj mora otrok priti po naslednje injekcije.
• Do not use this medicine after the expiry date which is stated on the carton.
• Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
It is not known whether the reduction in antibody levels has an impact on the protection against pneumococcal disease.
Ni znano ali znižanje ravni protiteles vpliva na zaščito proti pnevmokokni bolezni.
For children above 5 years old safety and efficacy of the vaccine have not been established, therefore vaccination of these children is not recommended.
Pri otrocih starejših od 5 let varnost in učinkovitost cepiva nista bili ocenjeni, zato cepljenje teh otrok ni priporočljivo.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Ker je korist cepljenja v tej skupini otrok velika, cepljenja ne bi smeli izpustiti ali odložiti.
However, taken together there was a trend for decrease in overall pneumococcal carriage.
V celoti pa je obstajal trend k zmanjšanju celotnega nosilstva pnevmokokov.
If not used within 6 hours it should be discarded.
Če ni porabljeno v 6 urah, ga morate zavreči.
The majority of these reactions were of mild to moderate severity and were not long lasting.
V večini primerov sta bila učinka blaga do zmerno huda in nista trajala dolgo.
Synflorix is not intended for use in adults.
Synflorix ni namenjen za uporabo pri odraslih.
When using a multidose vial, each 0.5 ml dose should be withdrawn using a sterile needle and syringe; precautions should be taken to avoid contamination of the contents.
Ko uporabljate večodmerno vialo, morate vsak 0,5-ml odmerek izvleči s sterilno iglo in brizgo; upoštevati morate previdnostne ukrepe, da boste preprečili onesnaženje vsebine.
Vaccine efficacy n
Učinkovitost cepiva n
Incidence per 100,000 person years
Incidenca na 100.000 človek-let
CI Confidence Interval
IZ interval zaupanja
Read all of this leaflet carefully before your child receives this vaccine because it contains important information for you.
Preden vaš otrok prične dobivati to cepivo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
In both studies there were significant decrease of individual serotypes 6B and 19F.
V obeh študijah so zabeležili značilno zmanjšanje individualnih serotipov 6B in 19F.
For adsorbent, see section 2.
Za adsorbente glejte poglavje 2.
The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact on pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographical areas.
Uporabo cepiva Synflorix je treba določiti na osnovi uradnih priporočil, upoštevaje vpliv pnevmokoknih bolezni po starostnih skupinah ter variabilnost epidemiologije na različnih geografskih območjih.
1 adsorbed on aluminium phosphate
1 adsorbiran na aluminijev fosfat
Pre-booster GMCs (8 to 12 months after the last primary dose) were generally similar for the two vaccines.
Predobnovitvena GMC (8 do 12 mesecev po zadnjem primarnem odmerku) je bila za obe cepivi na splošno podobna.
For children > 12 months of age, the risk of pain at the injection site may increase with increasing age.
Pri otrocih, starejših od 12 mesecev, se tveganje bolečin na mestu injiciranja morda povečuje z naraščajočo starostjo.
The vaccine efficacy against B-CAP observed at the interim analysis is presented below (table 2).
Učinkovitost cepiva proti B-CAP, ugotovljena pri vmesni analizi, je prikazana spodaj (preglednica 2).
Instructions for administration of the vaccine 1.
Navodila za injiciranje cepiva 1.
Do not administer intravascularly.
Ne injicirajte intravaskularno.
Pneumonia of different aetiologies is a leading cause of childhood morbidity and mortality globally.
Pljučnica različnih etiologij je po vsem svetu eden vodilnih vzrokov obolevnosti in umrljivosti v otroštvu.
Vaccine efficacy results in children > 36 months of age suggest a waning of protection.
Rezultati učinkovitosti cepiva pri otrocih, starejših od 36 mesecev, kažejo na upad zaščite.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti cepiva ne smete mešati z drugimi zdravili.
In general, comparable vaccine responses were observed for the different schedules, although somewhat higher immune responses were noted for the 2-4-6 month schedule.
Na splošno so pri različnih časovnih razporedih opažali primerljive odzive na cepivo, čeprav so bili imunski odzivi pri razporedu 2-4-6 mesecev nekoliko večji.
(95% CI: 7.7; 34.2)
(95 % IZ: 7,7, 34,2)
(4) Individual serotypes for which statistical significance was reached in the effectiveness analysis controlling for confounding factors (no adjustment for multiplicity performed).
(4) Posamezni serotipi, za katere je bila v analizi učinkovitosti dosežena statistična značilnost ob upoštevanju drugih vpletenih dejavnikov (brez korekcije za večkratne primerjave).
It is used to help protect your child from 6 weeks up to 5 years of age against: a bacteria called ‘Streptococcus pneumoniae'.
Uporabljamo ga za zaščito otrok od 6. tedna do 5. leta starosti pred: bakterijo, imenovano "Streptococcus pneumoniae".
Control(2)
Kontrole(2)
The implications of these findings for protective efficacy are not known.
Ni znano, kaj ti izsledki pomenijo za zaščitno učinkovitost.
Use with systemic immunosuppressive medicinal products
Uporaba s sistemskimi imunosupresivnimi zdravili
At least six months after the last injection, your child will receive an additional injection (booster).
Vsaj šest mesecev po zadnji injekciji bo otrok dobil še dodatno injekcijo (obnovitveni odmerek).
In prospective studies, Streptococcus pneumoniae was estimated to be responsible for 30-50% of pneumonia cases.
V prospektivnih študijah je bilo ocenjeno, da je za 30-50 % primerov bakterijskih pljučnic odgovoren Streptococcus pneumoniae.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja glede uporabe tega cepiva, vprašajte vašega zdravnika, farmacevta ali medicinsko sestro.
• The active substances are:
• Učinkovine so:
However, if your child gets any of these symptoms you should contact a doctor urgently.
Toda če se otroku pojavi kateri koli od teh simptomov, se morate nujno posvetovati z zdravnikom.
GlaxoSmithKline Biologicals 10, Tuas South Avenue 8 Singapore 637421
GlaxoSmithKline Biologicals 10, Tuas South Avenue 8 Singapur 637421
• temporarily stopping breathing (apnoea) if your child is born prematurely (before or at 28 weeks of pregnancy)
• prehodna ustavitev dihanja (apneja), če je otrok nedonošenček (rojen pred ali v 28. tednu nosečnosti)
After first opening of the 2-dose vial, immediate use is recommended.
Po prvem odprtju viale z 2 odmerkoma je priporočljivo, da cepivo uporabite takoj.
The proportion of subjects who received the booster dose in the ATP cohort was 92.3% in both analyses.
Delež oseb, ki so prejele poživitveni odmerek v kohorti po protokolu, je bil 92,3 % pri obeh analizah.
• your child is allergic to the active substance, or any of the other ingredients of this vaccine (listed in section 6).
• če je alergičen na učinkovine ali katero koli sestavino tega cepiva (navedeno v poglavju 6).
Streptococcus pneumoniae and Non-Typeable Haemophilus influenzae (NTHi) are the most common causes of bacterial AOM worldwide.
Streptococcus pneumoniae in netipizirani Haemophilus influenzae (NTHi) sta po vsem svetu najpogostejša povzročitelja bakterijskega akutnega vnetja srednjega ušesa.
Immunogenicity in special population
Imunogenost v posebnih populacijah
The vaccine is for intramuscular use only.
Cepivo je le za intramuskularno uporabo.
A minor infection such as a cold should not be a problem.
Blaga okužba, npr. prehlad, pa ne pomeni težave.
Efficacy and effectiveness in clinical trials
Učinkovitost v kliničnih študijah
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to any of the carrier proteins.
Preobčutljivost na učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1 ali katerokoli nosilno beljakovino.
Children with sickle cell disease
Otroci z boleznijo srpastih celic
It is important to follow the instructions from the doctor or nurse to complete the courses of injections.
Pomembno je, da upoštevate navodila zdravnika ali medicinske sestre, da bo otrok dobil celotno zaporedje injekcij.
Infants from 6 weeks to 6 months of age
Dojenčki od 6 tednov do 6 mesecev starosti
Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness.
Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Different injectable vaccines should always be given at different injection sites.
Različna cepiva za injiciranje je treba vedno aplicirati na različnih mestih.
Likely bacterial CAP (B-CAP) is defined as radiologically confirmed CAP cases with either alveolar consolidation/pleural effusion on the chest X-ray, or with non-alveolar infiltrates but with C reactive protein (CRP) ≥ 40 mg/l.
Verjetno bakterijsko povzročena CAP (B-CAP) je opredeljena kot radiološko potrjeni primeri CAP z bodisi alveolarno konsolidacijo/plevralnim izlivom na rentgenogramu prsnega koša bodisi z nealveolarnimi infiltrati, vendar s C-reaktivnim proteinom (CRP) ≥ 40 mg/l.
Type of IPD
Vrsta IPB
The immune responses elicited by Synflorix in previously unvaccinated older children were evaluated in three clinical studies.
Imunske odzive izzvane s cepivom Synflorix pri predhodno necepljenih starejših otrocih so ocenili v treh kliničnih študijah.
The results were not statistically significant across all analyses in COMPAS.
Rezultati v nobeni od analiz v študiji COMPAS niso bili statistično značilni.
Signs of an allergic reaction may include itchy skin rash, being short of breath and swelling of the face or tongue.
Med znaki alergijske reakcije so lahko srbeč izpuščaj na koži, kratka sapa in oteklost obraza ali jezika.
The antibodies form a part of the immune system that will protect your child against these diseases.
Protitelesa so del telesnega obrambnega (imunskega) sistema in otroka zaščitijo pred temi boleznimi.
Safety was also assessed in 435 previously unvaccinated children from 2 to 5 years old of which 285 subjects received 2 doses of Synflorix.
Varnost so ocenili tudi pri 435 predhodno necepljenih otrocih, starih od 2 do 5 let; 285 od teh je prejelo 2 odmerka cepiva Synflorix.
The 10 pneumococcal serotypes included in this vaccine represent the major disease-causing serotypes in Europe covering approximately 56% to 90% of invasive pneumococcal disease (IPD) in children <5 years of age.
Deseterica pnevmokoknih serotipov v tem cepivu predstavlja glavne patogene serotipe v Evropi in pokriva približno 56 do 90 % invazivnih pnevmokoknih bolezni pri otrocih, mlajših od 5 let.
The safety and efficacy of Synflorix in children over 5 years of age have not been established.
Varnost in učinkovitost cepiva Synflorix nista ugotovljeni pri otrocih, starejših od 5 let.
Multidose vial For storage conditions after first opening of the medicinal product, see section 6.3.
Za pogoje shranjevanja po prvem odprtju cepiva glejte poglavje 6.3.
Synflorix does not provide protection against other microorganisms.
Cepivo Synflorix ne nudi zaščite proti ostalim mikroorganizmom.
Furthermore, 19,466 children and 116 preterm infants received a booster dose of Synflorix in the second year of life.
Poleg tega je 19.466 otrok in 116 nedonošenčkov v 2. letu življenja dobilo obnovitveni odmerek cepiva Synflorix.
• The first injection may be given from the age of 6 weeks onwards.
• Prvo injekcijo lahko otrok dobi od 6. tedna starosti naprej.
Local reactogenicity of primary vaccination course was similar in infants < 12 months of age and in children > 12 months of age except for injection site pain for which the incidence increased with increasing age: pain was reported by more than 39% of the infants < 12 months of age and by more than 58% of the children > 12 months of age.
Lokalna reaktogenost po primarnem cepljenju je bila pri dojenčkih, mlajših od 12 mesecev, podobna kot pri otrocih, starejših od 12 mesecev, razen glede bolečin na mestu injiciranja; njihova incidenca se je povečevala z naraščajočo starostjo: bolečine so bile navedene pri več kot 39 % dojenčkih, mlajših od 12 mesecev, in pri več kot 58 % otrocih, starejših od 12 mesecev.
If a vaccine dose is withdrawn into a syringe for injection, the needle used for withdrawal must be replaced by a needle suitable for intramuscular injection.
Če odmerek cepiva povlečete v injekcijsko brizgo z injekcijsko iglo, je potrebno to injekcijsko iglo nadomestiti z injekcijsko iglo primerno za intramuskularno aplikacijo.
This bacteria can cause serious illnesses including meningitis, sepsis and bacteraemia (bacteria in blood stream) as well as ear infection or pneumonia.
Ta bakterija lahko povzroči resne bolezni, med drugim meningitis, sepso in bakteriemijo (bakterije v krvi), kot tudi okužbo ušes ali pljučnico.
Human data on the use during pregnancy or breast-feeding and animal reproduction studies are not available.
Podatkov o uporabi med nosečnostjo ali dojenjem pri človeku ni.
Efficacy against pneumonia was assessed in COMPAS.
Pljučnica Učinkovitost proti pljučnici so ocenili v študiji COMPAS.
The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children ≥ 2 years of age with conditions (such as sickle cell disease,
Uporaba konjugiranega pnevmokoknega cepiva ne nadomesti uporabe 23-valentnih pnevmokoknih polisaharidnih cepiv pri otrocih, starih ≥ 2 leti in z boleznimi (na primer boleznijo srpastih celic,
The interval between the pneumococcal conjugate vaccine (Synflorix) and the 23-valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
Presledek med konjugiranim pnevmokoknim cepivom (Synflorix) in 23-valentnim pnevmokoknim polisaharidnim cepivom ne sme biti krajši kot 8 tednov.
The response to serotype 7F was in the same range as for the seven serotypes in common between the two vaccines.
Odziv na serotip 7F je bil v enakem območju kot za sedem serotipov, skupnih obema cepivoma.
The first clinical study evaluated the immune responses for vaccine serotypes and the cross-reactive serotype 19A in children aged 7-11 months, 12-23 months and 2 to 5 years:
Prva klinična študija je ocenila imunske odzive za serotipe v cepivu in navzkrižno reaktivni serotip 19A pri otrocih v starosti od 7 do 11 mesecev, od 12 do 23 mesecev in od 2 do 5 let:
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, or if they have recently received any other vaccine.
Obvestite svojega zdravnika ali farmacevta, če otrok uporablja ali je pred kratkim uporabljal ali pa bo morda začel uporabljati katerokoli drugo zdravilo.
• Children aged 7-11 months received 2 primary doses followed by a booster dose in the second year of life.
• Otroci, stari od 7 do 11 mesecev, so dobili 2 primarna odmerka, ki jim je sledil obnovitveni odmerek v drugem letu življenja.
In a nested study, infants were followed up till approximately 21 months of age to assess impact on nasopharyngeal carriage and physician-diagnosed AOM reported by parents.
V gnezdeni študiji so dojenčke spremljali do približno 21. meseca starosti, da so ocenili vpliv na nazofaringealno nosilstvo in zdravniško diagnosticirano akutno vnetje srednjega ušesa po navedbi staršev.
The vaccine should be allowed to reach room temperature before use.
Cepivo morate pustiti, da pred uporabo doseže sobno temperaturo.
Immune memory
Imunski spomin
4-dose container 3 years
Vsebnik s 4 odmerki 3 leta
B. CONDITIONS OR RESTRICTION REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
For other vaccine serotypes, the number of AOM cases was too limited to allow any efficacy conclusion to be drawn.
Za druge serotipe v cepivu je bilo število primerov akutnega vnetja srednjega ušesa premajhno, da bi bilo mogoče sklepati o učinkovitosti.
The immunisation schedules for Synflorix should be based on official recommendations.
Sheme cepljenja s cepivom Synflorix morajo temeljiti na uradnih priporočilih.
Unvaccinated infants and children ≥ 7 months of age
Necepljeni dojenčki in otroci ≥ 7 mesecev starosti
Results suggest comparable reactogenicity and safety profile of Synflorix between these high risk groups and healthy children.
Rezultati kažejo, da sta reaktogenost in varnostni profil cepiva Synflorix v teh skupinah z velikim tveganjem podobna kot pri zdravih otrocih.
Effectiveness against physician-diagnosed AOM reported by parents was studied in the nested study within the FinIP trial.
Učinkovitost proti zdravniško diagnosticiranemu akutnemu vnetju srednjega ušesa po navedbi staršev so raziskali v gnezdeni študiji v okviru preskušanja FinIP.
If this applies to your child then the vaccination will be postponed until your child is feeling better.
V takšnem primeru bo zdravnik cepljenje odložil, dokler se otrokovo stanje ne izboljša.
After first opening of multidose vial:
Večodmerna viala po prvem odprtju:
• your child has a severe infection with a high temperature (over 38 °C).
• če ima kakšno hudo okužbo z visoko telesno temperaturo (več kot 38 °C).
In each group, persistence of the immune responses was observed at 24-27 months of age, i.e. up to 15 months following booster vaccination.
V vseh skupinah je bilo opaženo trajanje imunskega odziva pri starosti 24-27 mesecev, kar je do 15 mesecev po obnovitvenem cepljenju.
The effect of Synflorix on nasopharyngeal carriage was studied in 2 double-blind randomised studies using an inactive control: in the nested study of FinIP in Finland (5,023 subjects) and in COMPAS (1,700 subjects).
Vpliv cepiva Synflorix na nazofaringealno nosilstvo so raziskali v 2 dvojno slepih, randomiziranih študijah, v katerih so uporabljali neaktivno kontrolo: v gnezdeni študiji FinIP na Finskem (5.023 preiskovancev) in študiji COMPAS (1.700 preiskovancev).
Synflorix will only protect against infections caused by the bacteria for which the vaccine has been developed.
Cepivo Synflorix zaščiti samo pred okužbami z bakterijami, proti katerim je cepivo pripravljeno.
Bacteria can be responsible for 60-70% of clinical episodes of AOM.
Bakterije lahko povzročijo od 60 do 70 % kliničnih primerov akutnega vnetja srednjega ušesa.
There is insufficient evidence that Synflorix provides protection against pneumococcal serotypes not contained in the vaccine except the cross-reactive serotype 19A (see section 5.1) or against nontypeable Haemophilus influenzae.
Na voljo ni zadostnih dokazov, da cepivo Synflorix nudi zaščito pred pnevmokoknimi serotipi, ki jih cepivo ne vsebuje, razen pred navzkrižno reaktivnim serotipom 19A (glejte poglavje 5.1) ali proti netipiziranemu Haemophilus influenzae.
- 19A
- 6B
Invasive pneumococcal disease (which includes sepsis, meningitis, bacteraemic pneumonia and bacteraemia)
Invazivna pnevmokokna bolezen (ki vključuje sepso, meningitis, bakteriemično pljučnico in bakteriemijo)
It is not known whether this lower functional immune response against serotypes 1 and 5 will result in lower protective efficacy against invasive disease, pneumonia or otitis media caused by these serotypes (see section 5.1).
Ni znano, ali je zaradi manjšega funkcionalnega imunskega odziva proti serotipoma 1 in 5 zaščitna učinkovitost proti invazivni bolezni, pljučnici ali vnetju srednjega ušesa, ki jih povzročata ta serotipa, manjša (glejte poglavje 5.1).
Reactogenicity was higher in children receiving whole cell pertussis vaccines concomitantly.
Reaktogenost je bila večja pri otrocih, ki so sočasno dobivali cepivo proti oslovskemu kašlju s celimi celicami.
In a clinical study children received either Synflorix (N=603) or 7-valent Prevenar (N=203) concomitantly with a DTPw containing vaccine.
V klinični študiji so otroci dobili ali cepivo Synflorix (n = 603) ali 7-valentno cepivo Prevenar (n = 203) sočasno s cepivom, ki je vsebovalo DTPw.
Allergic reactions (such as eczema, allergic dermatitis, atopic dermatitis)
Bolezni imunskega sistema redki alergijske reakcije (npr. ekcem, alergijski dermatitis, atopični dermatitis)
As with all vaccines, Synflorix may not fully protect all children who are vaccinated.
Kot velja za vsa cepiva, je tudi pri cepivu Synflorix mogoče, da vseh cepljenih otrok ne zaščiti povsem.
asplenia, HIV infection, chronic illness, or those who have other immunocompromising conditions) placing them at higher risk for invasive disease due to Streptococcus pneumoniae.
asplenijo, okužbo s HIV, kronično boleznijo ali drugo obliko imunske oslabelosti), zaradi katerih imajo večje tveganje za invazivne bolezni s Streptococcus pneumoniae.
Very common Irritability Uncommon Crying abnormal
Psihiatrične motnje zelo pogosti razdražljivost občasni nenormalen jok
Immune responses to the extra three serotypes in Synflorix were also measured.
Izmerjeni so bili tudi imunski odzivi na dodatne tri serotipe v cepivu Synflorix.
Safety assessment of Synflorix was based on clinical trials involving the administration of 63,905 doses of Synflorix to 22,429 healthy children and 137 preterm infants as primary vaccination.
Varnostna ocena cepiva Synflorix je bila osnovana na kliničnih preskušanjih, ki so obsegala uporabo 63.905 odmerkov cepiva Synflorix pri 22.429 zdravih otrocih in pri 137 nedonošenčkih za primarno cepljenje.
Infants aged 7 to 11 months will receive 2 injections.
Dojenčki v starosti od 7 do 11 mesecev dobijo 2 injekciji.
The use of prophylactic antipyretic medicinal products is recommended: - for all children receiving Synflorix simultaneously with vaccines containing whole cell pertussis because of higher rate of febrile reactions (see section 4.8).
Profilaktična uporaba antipiretikov je priporočena: - za vse otroke, ki prejemajo cepivo Synflorix sočasno s polnoceličnimi cepivi proti oslovskemu kašlju, zaradi večje možnosti nastanka vročinskih reakcij (glejte poglavje 4.8).
Acute otitis media (AOM) is a common childhood disease with different aetiologies.
Akutno vnetje srednjega ušesa (akutni otitis media) je pogosta otroška bolezen z različnimi etiologijami.
Table 1: Number of vaccine serotype IPD cases and vaccine effectiveness (FinIP) or efficacy (COMPAS) in infants below 7 months of age at enrolment receiving at least one vaccine dose (Infant total vaccinated cohort)
Preglednica 1: Število primerov IPB s serotipi v cepivu ter učinkovitost cepiva (FinIP in COMPAS) pri dojenčkih, ob vključitvi mlajših od 7 mesecev, ki so prejeli vsaj en odmerek cepiva (v celoti cepljena kohorta dojenčkov)
Children should receive the dose regimen of Synflorix that is appropriate to their age at the time of commencing the vaccination series (see section 4.2).
Za otroke je treba uporabiti takšno odmerno shemo cepiva Synflorix, ki ustreza njihovi starosti na začetku zaporedja cepljenja (glejte poglavje 4.2).
It has also been demonstrated that Synflorix induces an immune response to the cross-reactive serotype 19A with 48.8% (95% CI: 42.9; 54.7) of vaccinees reaching an OPA titre ≥ 8 one month after a booster dose.
Dokazano je bilo tudi, da cepivo Synflorix inducira imunski odziv na navzkrižno reaktivni serotip 19A pri 48,8 % (95 % IZ: 42,9, 54,7) cepljenih, ki dosežejo titer OPA ≥ 8 en mesec po obnovitvenem odmerku.