natgillin/translations-raw huggingface dataset:
For Prevenar 13 recipients, the proportion of responders with an OPA titre  1:8 was at least 87% following the infant series, and at least 93% following the booster dose. 
Pri prejemnikih cepiva Prevenar 13 je bil delež preskušancev s titri OPA ≥ 1:8 vsaj 87 % po shemi cepljenja dojenčkov in vsaj 93 % po obnovitvenem odmerku.
For each of the 6 additional serotypes, Prevenar 13 elicited OPA titres ≥ 1:8 in 91.4% to 100% of vaccinees one month after the primary series in studies 004/006. 
Za vsakega od 6 dodatnih serotipov je cepivo Prevenar 13 izzvalo titre OPA ≥ 1:8 en mesec po osnovnem cepljenju v študijah 004/006 v 91,4 % do 100 %.
In an ongoing surveillance system (2004 to 2013) to document the impact of Prevenar and subsequently Prevenar 13 on CAP in children less than 5 years in Southern Israel using a 2 dose primary series with a booster dose in the second year of life, there was a reduction of 68% (95% CI 73; 61) in outpatient visits and 32% (95% CI 39; 22) in hospitalizations for alveolar CAP following the introduction of Prevenar 13 when compared to the period before the introduction of Prevenar. 
V potekajočem sistemu spremljanja (od 2004 do 2013) v južnem Izraelu z namenom dokumentiranja učinka cepiva Prevenar in nato cepiva Prevenar 13 z osnovno shemo z dvema odmerkoma ter obnovitvenim odmerkom v drugem letu življenja na CAP pri otrocih, mlajših od 5 let, so po uvedbi cepiva Prevenar 13 ugotovili zmanjšanje ambulantnih obiskov za 68 % (95 % IZ 73; 61) in hospitalizacij zaradi alveolarne CAP za 32 % (95 % IZ 39; 22) v primerjavi z obdobjem pred uvedbo cepiva Prevenar.
Pack sizes of 1, 10 and 50, with or without needle. 
Velikosti pakiranja po 1, 10 in 50, z injekcijsko iglo ali brez nje.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET S CEPIVOM
The vaccine is a homogeneous white suspension. 
suspenzija za injiciranje Cepivo je homogena, bela suspenzija.
Children and adolescents 6 to 17 years of age should receive one injection. 
Otroci in mladostniki, stari od 6 do 17 let, morajo prejeti en odmerek cepiva.
Children and adolescents with either HIV infection, sickle cell disease or a blood-forming stem cell transplant had similar side effects however the frequencies of headaches, vomiting, diarrhoea, fever, fatigue, joint and muscle pain were very common. 
Otroci in mladostniki z okužbo z virusom HIV, srpastocelično anemijo ali presadkom krvotvornih matičnih celic so imeli podobne neželene učinke, vendar so bili glavobol, bruhanje, driska, vročina, utrujenost in bolečine v sklepih in mišicah zelo pogosti.
General disorders and administration site conditions: Vaccination-site urticaria; vaccination-site dermatitis; vaccination-site pruritus; flushing 
Splošne težave in spremembe na mestu aplikacije: urtikarija na mestu cepljenja, dermatitis na mestu cepljenja, srbenje na mestu cepljenja, rdečica
In babies born very prematurely (at or before 28 weeks of gestation), longer gaps than normal between breaths may occur for 2-3 days after vaccination. 
Pri veliko prezgodaj rojenih otrocih (v 28. tednu nosečnosti ali prej) se lahko 2-3 dni po cepljenju pojavijo nenormalno dolgi presledki med posameznimi vdihi.
Following the booster dose, antibody concentrations increased from the pre-booster level for all 13 serotypes. 
Po obnovitvenem odmerku so se koncentracije protiteles zvečale v primerjavi z vrednostmi pred obnovitvenim odmerkom za vseh 13 serotipov.
When Prevenar 13 was given concomitantly with TIV, the immune responses to Prevenar 13 were lower compared to when Prevenar 13 was given alone, however, there was no long-term impact on circulating antibody levels. 
Ob sočasnem dajanju cepiva Prevenar 13 in cepiva TIV je bil imunski odziv na cepivo Prevenar 13 slabši kot ob samostojnem dajanju cepiva Prevenar 13, vendar ni bilo dolgoročnega vpliva na raven cirkulirajočih protiteles.
Statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR was greater than 1. 
Statistično pomembno večji odziv je bil definiran s spodnjo mejno vrednostjo 2-stranskega 95 % intervala zaupanja (IZ) za GMR, večjo od 1.
In all adults ≥ 50 years who received a single dose of Prevenar 13, the OPA titers to serotype 6A were significantly greater than in adults ≥ 60 years who received a single dose of 23-valent pneumococcal polysaccharide vaccine. 
Pri vseh odraslih, starih ≥ 50 let, ki so prejeli en sam odmerek cepiva Prevenar 13, so bili titri OPA na serotip 6A statistično pomembno večji kot pri odraslih, starih ≥ 60 let, ki so prejeli en sam odmerek 23-valentnega pnevmokoknega polisaharidnega cepiva.
Additional serotypes covered by Prevenar 13 
Dodatni serotipi, ki jih vsebuje cepivo Prevenar 13
Children < 5 years of age. 
Otroci, mlajši od 5 let.
20 to 1234 
20 do 1.234
Prevenar OPA GMT Relative to PPSV23 
GMT OPA pri cepivu Prevenar v primerjavi s PPSV23
Vomiting; diarrhoea 
bruhanje, diareja
Pyrexia > 39°C; vaccination-site movement impairment (due to pain); vaccination-site erythema or induration/swelling 2.5 cm-7.0 cm (after infant series) 
pireksija > 39 °C, motena gibljivost na mestu cepljenja (zaradi bolečine), rdečina ali zatrdlina/oteklina na mestu cepljenja 2,5 cm-7,0 cm v premeru (po shemi cepljenja za dojenčke)
In clinical studies when Prevenar 13 was given 1 year after 23-valent pneumococcal polysaccharide vaccine the immune responses were lower for all serotypes compared to when Prevenar 13 was given to subjects not previously immunised with 23-valent pneumococcal polysaccharide vaccine. 
V kliničnih študijah, v katerih so cepivo Prevenar 13 dali 1 leto po 23-valentnem pnevmokoknem polisaharidnem cepivu, so bili imunski odzivi za vse serološke tipe slabši v primerjavi z odzivi ob dajanju cepiva Prevenar 13 posameznikom, ki predhodno niso bili imunizirani s 23-valentnim pnevmokoknim polisaharidnim cepivom.
In a multicenter observational study in France comparing the periods before and after the switch from Prevenar to Prevenar 13, there was 16% (2060 to 1725 cases) reduction in all community acquired pneumonia (CAP) cases in emergency departments in children 1 month to 15 years of age. 
V multicentrični opazovalni študiji v Franciji, v kateri so primerjali obdobje pred in po prehodu s cepiva Prevenar na cepivo Prevenar 13, so na oddelkih za nujno pomoč ugotovili 16 % (z 2.060 na 1.725 primerov) zmanjšanje vseh primerov CAP pri otrocih, starih od 1 meseca do 15 let.
Table 1: Comparison of the proportion of subjects achieving a pneumococcal anti-polysaccharide IgG antibody concentration ≥ 0.35 μg/ml after dose 3 of the infant series - study 006 
Preglednica 1: Primerjava deleža preskušancev s koncentracijo pnevmokoknih polisaharidnih protiteles IgG ≥ 0,35 μg/ml po tretjem odmerku sheme cepljenja dojenčkov - študija 006
Conjugated to CRM197 carrier protein, adsorbed on aluminium phosphate. 
2,2 µg konjugiran na nosilno beljakovino CRM197, adsorbiran na aluminijev fosfat.
†, which is unique to Prevenar 13, a statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR being greater than 2. 
†, ki je značilen samo za cepivo Prevenar 13, je bil statistično pomembno večji odziv definiran s spodnjo mejno vrednostjo 2-stranskega 95 % intervala zaupanja (IZ) za GMR, večjo od 2.
1, 5, 10, 25, 50 multidose containers 
1, 5, 10, 25, 50 večodmernih vsebnikov
After a booster dose at 12 to 15 months of age, fever ≥ 38°C was reported in 50.0% of infants who received Prevenar (7-valent) and Infanrix hexa at the same time as compared to 33.6% of infants receiving Infanrix hexa alone. 
Po obnovitvenem odmerku, prejetem pri 12 do 15 mesecih starosti, so o zvišani telesni temperaturi ≥ 38 °C poročali pri 50,0 % otrok, ki so prejeli cepivo Prevenar (7-valentno) skupaj s cepivom Infanrix hexa, v primerjavi s 33,6 % otrok, ki so prejeli samo cepivo Infanrix hexa.
• Each injection will be given at least one month apart. 
• Vse nadaljnje odmerke bo prejel z vsaj enomesečnim presledkom med odmerki.
Table 4: Summary of effectiveness of 7-valent Prevenar for invasive pneumococcal disease Country (year of introduction) 
Preglednica 4: Povzetek učinkovitosti 7-valentnega cepiva Prevenar proti invazivnim pnevmokoknim boleznim
No data are available regarding concomitant use with other vaccines. 
Podatki o sočasni uporabi z drugimi cepivi niso na voljo.
The safety of the vaccine was assessed in controlled clinical studies where 14,267 doses were given to 4,429 healthy infants from 6 weeks of age at first vaccination and 11-16 months of age at booster dose. 
Varnost cepiva je bila ocenjena v nadzorovanih kliničnih študijah, v katerih je 4.429 zdravih dojenčkov prejelo 14.267 odmerkov cepiva.
Multidose Container Label 
Nalepka na večodmernem vsebniku
(95% CI) 
(95% IZ)
Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly. 
Aktivna imunizacija za preprečevanje invazivnih bolezni in pljučnice, ki jih povzroča Streptococcus pneumoniae, pri odraslih, starih 18 let in več, ter starejših.
1 dose (0.5 ml) contains approximately 32 µg CRM197 carrier protein and 0.125 mg aluminium. 
En odmerek (0,5 ml) vsebuje približno 32 µg nosilne beljakovine CRM197 in 0,125 mg aluminija.
Prevenar 13 suspension for injection in multidose container IM 
Prevenar 13 suspenzija za injiciranje v večodmernem vsebniku i.m.
The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown. 
Imunski odziv za serotip 3 po obnovitvenem odmerku ni dosegel nivoja, ki so ga opažali po osnovni shemi cepljenja dojenčkov; klinični pomen tega opažanja glede indukcije imunskega spomina za serotip 3 ni znan.
1 dose (0.5 ml) contains approximately 32 µg CRM197 carrier protein, adsorbed on aluminium phosphate (0.125 mg aluminium). 
En odmerek (0,5 ml) vsebuje približno 32 µg nosilne beljakovine CRM197, adsorbirane na aluminijev fosfat (0,125 mg aluminija).
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. 
Pri cepljenju je, tako kot pri vseh cepivih, ki se injicirajo, treba zagotoviti ustrezno obliko zdravljenja in zdravniškega nadzora, ki mora biti v takšnem primeru nemudoma na voljo.
The following additional side effects have been seen with Prevenar 13 in infants and children up to 5 years of age in postmarketing experience 
Naslednje dodatne neželene učinke so ugotovili pri cepivu Prevenar 13 pri dojenčkih in otrocih, starih do 5 let, v obdobju trženja cepiva:
Both studies were randomised, double-blind, active-control studies in which infants were randomised to receive either Prevenar or control vaccine (NCKP, meningococcal serogroup C CRM-conjugate [MnCC] vaccine; FinOM, hepatitis B vaccine) in a four-dose series at 2, 4, 6, and 12-15 months of age. 
Obe študiji sta bili randomizirani, dvojno slepi študiji z aktivnimi kontrolami, v katerih so bili dojenčki randomizirani, da bodo pri 2, 4, 6 in 12-15 mesecih starosti v zaporedju štirih odmerkov prejeli bodisi cepivo Prevenar bodisi kontrolno cepivo (NCKP, cepivo proti meningokokom serološke skupine C, konjugirano s CRM [MnCC]; FinOM, cepivo proti hepatitisu B).
What Prevenar 13 looks like and contents of the pack 
Izgled cepiva Prevenar 13 in vsebina pakiranja
The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown (see section 5.1). 
Imunski odziv za serotip 3 po obnovitvenem odmerku ni porasel nad nivo, ki so ga opazili po osnovnem cepljenju dojenčkov; klinični pomen tega opažanja indukcije imunskega spomina serotipa 3 ni znan (glejte poglavje 5.1).
Musculoskeletal and connective tissue disorders: Very common: 
Bolezni mišično-skeletnega sistema in vezivnega tkiva: Zelo pogosti:
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, local tolerance, and reproduction and developmental toxicity. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnem odmerku in ponavljajočih se odmerkih, lokalnega prenašanja ter vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
After the second dose immune responses were comparable to those after the first dose. 
Po drugem odmerku je bil imunski odziv primerljiv z odzivom po prvem odmerku.
The following side effects include those reported for Prevenar 13 in children and adolescents (6 to 17 years of age): 
O naslednjih neželenih učinkih so poročali pri uporabi cepiva Prevenar 13 pri otrocih in mladostnikih (starih od 6 do 17 let):
Marketing Authorisation Holder: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles 
Imetnik dovoljenja za promet s cepivom: Pfizer Europe MA EEIG Boulevard de la Plaine 17
Additional serotypes in Prevenar 13 
Dodatni serotipi v cepivu Prevenar 13
Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions, with or without fever, and HHE when comparing groups which reported use of Prevenar 13 with Infanrix hexa to those which reported use of Prevenar 13 alone. 
Analiza stopenj poročanja iz obdobja trženja cepiva kaže na možnost zvečanja tveganja za konvulzije z vročino ali brez nje ter epizode hipotonije in zmanjšane odzivnosti, kadar primerjamo skupino, ki je prejemala cepivo Prevenar 13 sočasno s cepivom Infanrix hexa, s skupino, ki je prejemala samo cepivo Prevenar 13.
Infants and children aged 6 weeks to 5 years 
Dojenčki in otroci, stari od 6 tednov do 5 let
In a clinical study in infants vaccinated at 2, 3, and 4 months of age, fever ≥ 38°C was reported at higher rates among infants who received Prevenar (7-valent) concomitantly with Infanrix hexa (28.3% to 42.3%) than in infants receiving Infanrix hexa alone (15.6% to 23.1%). 
V kliničnih študijah pri otrocih, ki so bili cepljeni pri 2, 3 ali 4 mesecih starosti, so pri sočasni uporabi cepiva Prevenar (7-valentnega) s cepivom Infanrix hexa pogosteje poročali o zvišani telesni temperaturi ≥ 38 °C (28,3 % do 42,3 %) kot pri otrocih, ki so prejeli samo cepivo Infanrix hexa (15,6 % do 23,1 %).
% Incidence reduction (95% CI*) 
% zmanjšanje incidence (95 % IZ*)
Pack sizes of 1, 5, 10, 25 and 50. 
Pakiranja po 1, 5, 10, 25 in 50.
OPA GMT levels at baseline OPA GMT levels one year after Prevenar 13 
Ravni GMT OPA na začetku Ravni GMT OPA eno leto po cepljenju s cepivom Prevenar 13
One year after vaccination with Prevenar 13 in adults aged 70 years and over who were vaccinated with 23-valent pneumococcal polysaccharide vaccine, at least 5 years prior to study entry, OPA titers had declined compared to one month after vaccination, however, OPA titers for all serotypes remained higher than levels at baseline: 
Eno leto po cepljenju s cepivom Prevenar 13 so se pri odraslih, starih 70 let in več, ki so bili s 23-valentnim pnevmokoknim polisaharidnim cepivom cepljeni najmanj 5 let pred vstopom v študijo, titri OPA zmanjšali v primerjavi s titri 1 mesec po cepljenju, vendar pa so titri OPA za vse serotipe ostali večji od izhodiščnih ravni:
GMR (95% CI) 
GMR (95 % IZ)
No data are currently available regarding concomitant use with other vaccines. 
Podatki o sočasni uporabi z drugimi cepivi trenutno niso na voljo.
As per general recommendations, a single dose of 23-valent pneumococcal polysaccharide vaccine was subsequently administered. 
Nato so skladno s splošnimi priporočili prejeli enkratni odmerek 23-valentnega pnevmokoknega polisaharidnega cepiva.
Prevenar (7-valent vaccine) protective efficacy in infants and children 
Učinkovitost zaščite dojenčkov in otrok s cepivom Prevenar (7-valentno cepivo)
Acute otitis media (AOM) is a common childhood disease with different aetiologies. 
Akutno vnetje srednjega ušesa je pogosta otroška bolezen z različnimi vzroki.
Pivotal trials for Prevenar 13 were designed to show that functional OPA antibody responses for the 13 serotypes are non-inferior, and for some serotypes superior, to the 12 serotypes in common with the licensed 23-valent pneumococcal polysaccharide vaccine [1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 
Ključna preskušanja pri cepivu Prevenar 13 so bila načrtovana z namenom, da bi pokazali, da so odzivi funkcionalnih protiteles OPA za 13 serotipov enakovredni, za nekatere serotipe pa boljši kot pri 12 serotipih, ki so skupni cepivu Prevenar 13 ter odobrenemu 23-valentnemu pnevmokoknemu polisaharidnemu cepivu [1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] 1 mesec po cepljenju.
Prevenar (7-valent) effectiveness 
Učinkovitost (7-valentnega) cepiva Prevenar
The following frequencies are based on adverse reactions assessed in Prevenar 13 clinical studies in adults: 
Naslednji podatki o pogostnosti temeljijo na neželenih učinkih iz kliničnih študij cepiva Prevenar 13 pri odraslih:
Children and adolescents with sickle cell disease, HIV infection, or an haematopoietic stem cell transplant have similar frequencies of adverse reactions, except that headaches, vomiting, diarrhoea, pyrexia, fatigue, arthralgia, and myalgia were very common. 
Pri otrocih in mladostnikih s srpastocelično anemijo, okužbo z virusom HIV ali presadkom hematopoetskih matičnih celic je pogostnost neželenih učinkov podobna, z izjemo glavobola, bruhanja, diareje, pireksije, utrujenosti, artralgije in mialgije, ki so bili zelo pogosti.
18C 1939 19A 19F 23F Non-inferiority was defined as the lower limit of the 2-sided 95% CI for GMR was greater than 0.5. 
18C 1.939 19A 19F 23F Enakovrednost je bila definirana s spodnjo mejno vrednostjo 2-stranskega 95 % intervala zaupanja (IZ) za GMR, večjo od 0,5.
If you or your child get any side effects, talk to your doctor, pharmacist, or nurse. 
Če pri sebi ali pri svojem otroku opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Typically, your child should receive an initial course of three injections of the vaccine followed by a booster dose. 
Običajno bo otrok med osnovnim cepljenjem prejel tri odmerke cepiva, temu bo sledil obnovitveni odmerek.
(95% CI 
(95 % IZ
The OPA geometric mean titres for serotypes 1, 3 and 5 were lower than the titres for each of the other additional serotypes; the clinical relevance of this observation is unknown. 
Geometrične sredine titrov OPA za serotipe 1, 3 in 5 so bile manjše kot titri posameznih drugih dodatnih serotipov; klinični pomen tega opažanja ni znan.
Pneumococcal polysaccharide serotype 1 
pnevmokokni polisaharid serotipa 1
Pyrexia; irritability; any vaccination-site erythema, induration/swelling or pain/tenderness; somnolence; poor quality sleep Vaccination-site erythema or induration/swelling 2.5 cm-7.0 cm (after the booster dose and in older children [age 2 to 5 years]) 
pireksija, razdražljivost, rdečina, zatrdlina/oteklina ali bolečina/občutljivost na mestu cepljenja, somnolenca, motnje spanja; rdečina ali zatrdlina/oteklina na mestu cepljenja 2,5 cm-7,0 cm v premeru (po cepljenju z obnovitvenim odmerkom in pri starejših otrocih [starih od 2 leti do 5 let])
Prevenar 13 elicited comparable, although slightly lower, antibody levels than Prevenar for the 7 common serotypes. 
Cepivo Prevenar 13 je za sedem skupnih serotipov izzvalo primerljive, čeprav nekoliko manjše vrednosti protiteles kot cepivo Prevenar.
Single Dose Vial Label 
Nalepka na enoodmerni viali
Infants and children who have begun immunisation with Prevenar may switch to Prevenar 13 at any point in the schedule. 
Pri dojenčkih in otrocih, pri katerih se je cepljenje začelo s cepivom Prevenar, se lahko preide na cepivo Prevenar 13 kadarkoli med shemo.
The functional antibody (OPA) geometric mean titres for serotypes 1, 3 and 5 were lower than the titres for each of the other additional serotypes; the clinical relevance of this observation for protective efficacy is unknown. 
Geometrične sredine titrov funkcionalnih protiteles (OPA) za serotipe 1, 3 in 5 so bile manjše kot titri posameznih drugih dodatnih serotipov; klinični pomen tega opažanja na učinkovitost zaščite ni znan.
Serotypes 
Serotipi
Table 7: OPA GMTs in adults aged 60-64 years given Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine (PPSV23) and in adults aged 50-59 years given Prevenar 13 
Preglednica 7: GMT OPA pri odraslih, starih 60 do 64 let, ki so prejeli cepivo Prevenar 13 ali 23-valentno pnevmokokno polisaharidno cepivo (PPSV23) in pri odraslih, starih 50 do 59 let, ki so prejeli cepivo Prevenar 13
The third (booster) dose is recommended between 11 and 15 months of age (see section 5.1). 
Cepljenje s tretjim (obnovitvenim) odmerkom je priporočljivo opraviti v starosti od 11. do 15. meseca (glejte poglavje 5.1).
2 ml (4 x 0.5 ml doses) suspension for injection in a container (Type I glass) with a latex-free grey chlorobutyl rubber stopper and sealed with an aluminum flip-off seal and a polypropylene flip-off cap. 
2 ml (4 x 0,5 ml odmerek) suspenzije za injiciranje v vsebniku (steklo tipa I) z zamaškom iz sive klorobutilne gume brez lateksa, s snemljivo zaporko iz aluminija ter snemljivim pokrovčkom iz polipropilena.
Immune responses after the fourth dose of Prevenar 13 were significantly increased for all serotypes compared with after the third dose. 
Po četrtem odmerku cepiva Prevenar 13 je bil imunski odziv statistično pomembno večji za vse serotipe v primerjavi s tretjim odmerkom.
In adults vaccinated with pneumococcal polysaccharide vaccine at least 5 years prior to the clinical study, OPA GMTs to Prevenar 13 were non-inferior to the 23-valent pneumococcal polysaccharide vaccine responses for the 12 serotypes in common. 
Pri odraslih, cepljenih s pnevmokoknim polisaharidnim cepivom najmanj 5 let pred klinično študijo, so bile vrednosti geometričnih sredin titrov (GMT) OPA za cepivo Prevenar 13 enakovredne kot odzivi na 23-valentno pnevmokokno polisaharidno cepivo za 12 skupnih serotipov.
The following side effects include those reported for Prevenar 13 in infants and children (6 weeks to 5 years of age): 
O naslednjih neželenih učinkih so poročali pri uporabi cepiva Prevenar 13 pri dojenčkih in otrocih (starih od 6 tednov do 5 let):
Episodes 
Primeri
Prevenar 13 suspension for injection IM 
Prevenar 13 suspenzija za injiciranje i.m.
• Hives (urticaria), redness and irritation (dermatitis) and itching (pruritus) at the vaccination-site; flushing 
• koprivnica (urtikarija), rdečina in draženje (vnetje kože) ter srbenje (pruritus) na mestu cepljenja; pordevanje
A fourth injection (booster) is recommended 6 months after the third injection. 
Cepljenje s četrtim (obnovitvenim) odmerkom je priporočljivo opraviti 6 mesecev po tretjem cepljenju.
In these two studies pneumococcal immune responses were compared using a set of non-inferiority criteria including the percentage of subjects with serum anti-polysaccharide serotype-specific IgG ≥ 0.35 μg/ml one month after the primary series and the comparison of IgG geometric mean concentrations (ELISA GMCs); in addition, functional antibody titres (OPA) between subjects receiving Prevenar 13 and Prevenar were compared. 
V teh dveh študijah so primerjali imunske odzive proti pnevmokoku z nizom meril enakovrednosti, med drugim: odstotni delež preskušancev z vrednostjo za antipolisaharidni serotip specifičnih IgG v serumu ≥ 0,35 μg/ml en mesec po osnovnem cepljenju, primerjava geometričnih srednjih koncentracij IgG (geometrična srednja koncentracija (GMC) ELISA); poleg tega so primerjali titre funkcionalnih protiteles (OPA) med preskušanci, ki so prejeli cepivo Prevenar 13, in preskušanci, ki so prejeli cepivo Prevenar.
0.5 ml suspension for injection in pre-filled syringe (Type I glass) with a plunger stopper (latex-free chlorobutyl rubber) and protective-tip cap (latex-free isoprene bromobutyl rubber). 
0,5 ml suspenzije za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) z batom s tesnilom iz klorobutilne gume brez lateksa in zaščitnim pokrovčkom konice brizge (izopren-bromobutilna guma brez lateksa).