FrancophonIA/ELRC3.0 huggingface dataset:
English: Diarrhoea; vomiting (in adults aged 18 to 49 years)
Danish: Diaré, opkastning (hos voksne i alderen 18-49 år).
English: Following administration of a single dose of Prevenar 13 to children (12-59 months) who are considered completely immunised with Prevenar (7-valent) (either 2 or 3 dose primary series plus booster), the proportion achieving serum IgG levels ≥0.35 µg/ml and OPA titres ≥1:8 was at least 90%.
Danish: Efter administration af 1 enkelt dosis Prevenar 13 til børn (12-59 måneder), som er fuldt immuniseret med Prevenar (7-valent) (enten 2- eller 3-dosis primær serie plus booster), var andelen, der opnåede IgG-niveauer ≥ 0,35 mikrogram/ml og OPA-titre ≥ 1:8, mindst 90 %.
English: Prevenar 13 must not be administered intravascularly.
Danish: Prevenar 13 må ikke administreres intravaskulært.
English: The risk for CAP and IPD in adults also increases with chronic underlying medical conditions, specifically, anatomical or functional asplenia, diabetes mellitus, asthma, chronic cardiovascular, pulmonary, kidney or liver disease, and it is highest in those who are immune-suppressed such as those with malignant haematological diseases or HIV infection.
Danish: Risikoen for CAP og IPD hos voksne øges desuden med underliggende kroniske sygdomstilstande, særligt ved anatomisk eller funktionel aspleni, diabetes mellitus, astma, kronisk kardiovaskulær eller pulmonal sygdom, nyre- eller leversygdom, og risikoen er højest hos immunsupprimerede personer, f.eks. personer med maligne hæmatologiske sygdomme eller hiv-infektion.
English: The following side effects include those reported for Prevenar 13 in adults:
Danish: Følgende bivirkninger omfatter indberettede bivirkninger ved Prevenar 13 hos voksne:
English: Haematopoietic stem cell transplant
Danish: Hæmatopoietisk stamcelletransplantation
English: The decrease in all cause pneumonia cases was most pronounced in the younger vaccinated age groups with a decrease of 31.8% (757 to 516 cases) and 16.6% (833 to 695 cases) in the age groups <2 years and 2 to 5 years, respectively.
Danish: Reduktionen af pneumoni af alle årsager var mest udtalt i den yngre vaccinationsaldersgruppe med en nedgang på henholdsvis 31,8 % (757 til 516 tilfælde) og 16,6 % (833 til 695 tilfælde) i aldersgruppen < 2 år og 2 - 5 år.
English: First episode of confirmed VT pneumococcal CAP
Danish: Første episode af bekræftet VTpneumokok-CAP
English: Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13 (as per local recommendations).
Danish: Prevenar 13 kan også gives samtidigt med tetanustoksoid-konjugeret meningokokpolysaccharidvaccine serogruppe A, C, W og Y til børn i alderen 12-23 måneder, som tidligere er blevet immuniseret med Prevenar 13 (i henhold til lokale anbefalinger).
English: Manufacturer responsible for batch release: Pfizer Manufacturing Belgium N.V. Rijksweg 12
Danish: Fremstiller ansvarlig for batchfrigivelse: Pfizer Manufacturing Belgium N.V.
English: Table 8: OPA GMTs in adults aged 18-49 years and 60-64 years given Prevenar 13
Danish: Tabel 8: OPA-GMT hos voksne i alderen 18-49 år og 60-64 år, der har fået Prevenar 13
English: Tηλ: +357 22 817690
Danish: Τηλ: +357 22 817690
English: As per general recommendations, a single dose of 23-valent pneumococcal polysaccharide vaccine was subsequently administered.
Danish: I overensstemmelse med de generelle anbefalinger blev en enkelt dosis 23-valent pneumokok polysaccharidvaccine indgivet derefter.
English: The non-inferiority immune response comparisons for study 006, based on the proportion of infants achieving anti-polysaccharide IgG concentrations ≥ 0.35 μg/ml, are shown in Table 1.
Danish: Sammenligningerne af non-inferioritet immunresponset for studie 006, baseret på andelen af spædbørn som opnåede anti-polysaccharid IgG-koncentrationer ≥ 0,35 μg/ml, ses i tabel 1.
English: • A fourth injection (booster) will be given between 11 and 15 months of age.
Danish: • Den fjerde indsprøjtning (booster) gives i alderen fra 11 til 15 måneder.
English: Non-inferiority for the proportion of subjects achieving an IgG concentration 0.35 μg/ml was demonstrated for all 13 serotypes (lower bound of the 97.5% confidence interval (CI) for the difference in percentage of responders at 0.35 µg/ml between groups was >-10%).
Danish: Der blev påvist non-inferioritet for andelen af forsøgspersoner, der fik en IgG-koncentration  0,35 μg/ml for alle 13 serotyper (den nedre grænse af 97,5 % konfidensintervallet (CI) for forskellen i procent af respondenter ved 0,35 µg/ml mellem grupperne var >-10 %).
English: Immune responses after the fourth dose of Prevenar 13 were significantly increased for all serotypes compared with after the third dose.
Danish: Immunresponset efter den fjerde dosis Prevenar 13 var signifikant højere for alle serotyper sammenlignet med niveauet efter den tredje dosis.
English: What you need to know before you or your child receives Prevenar 13
Danish: Det skal De vide, før De eller Deres barn får Prevenar 13
English: In a third study in adults aged 50-93 years, it was demonstrated that Prevenar 13 may be given concomitantly with the seasonal quadrivalent inactivated influenza vaccine (QIV).
Danish: I et tredje studie med voksne i alderen 50-93 år blev det vist, at Prevenar 13 kan gives samtidig med årstidsbestemt tetravalent inaktiveret influenzavaccine (QIV).
English: 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.
Danish: Efter en booster-dosis ved 12-15-måneders alderen blev feber ≥ 38 °C rapporteret hos 50,0 % af de børn, der fik Prevenar (7-valent) og Infanrix hexa samtidig, sammenlignet med 33,6 % hos børn, der fik Infanrix alene.
English: Based on surveillance data following the introduction of Prevenar but before the introduction of Prevenar 13 in childhood vaccination programmes, the pneumococcal serotypes in Prevenar 13 may be responsible for at least 50 - 76% (depending on country) of IPD in adults.
Danish: Baseret på overvågningsdata efter markedsføring af Prevenar, men før Prevenar 13 blev inkluderet i børnevaccinationsprogrammet, kan pneumokokserotyperne i Prevenar 13 være ansvarlige for mindst 50-76 % af tilfældende af IPD hos voksne (afhængigt af land).
English: According to official recommendations in your country, an alternative schedule may be used by your healthcare provider.
Danish: Sundhedsvæsenet i Danmark kan anvende en anden plan i henhold til de officielle anbefalinger.
English: 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.
Danish: For personer, som fik Prevenar 13, var andelen af respondenter med OPA titre ≥ 1:8 mindst 87 % efter spædbarnsvaccinationsserien og mindst 93 % efter boosterdosen.
English: 2, 4, 6, + 12-15 months
Danish: 2, 4, 6, 12 og 15 måneder
English: Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Prevenar 13 should receive 23-valent pneumococcal polysaccharide vaccine.
Danish: Når det anbefales, skal børn i risikogruppen, som er ≥ 24 måneder og allerede immuniseret med Prevenar 13, have 23-valent pneumokok polysaccharidvaccine.
English: The following side effects include those reported for Prevenar 13 in infants and children (6 weeks to 5 years of age):
Danish: Følgende bivirkninger er indberettet for Prevenar 13 for spædbørn og børn (i alderen 6 uger til 5 år) :
English: More than 85% achieved a pneumococcal polysaccharide IgG binding antibody concentration ≥0.35 µg/mL 1 month after the infant series, except for serotypes 5 (71.7%), 6A (82.7%), and 6B (72.7%) in the preterm group.
Danish: Mere end 85 % opnåede en polysaccharid-pneumokok-IgG-bindende antistofkoncentration på ≥ 0,35 µg/ml 1 måned efter spædbørnsserien, med undtagelse af serotype 5 (71,7 %), 6A (82,7 %) og 6B (72,7 %) i den præmature gruppe.
English: For adjuvant, see section 2.
Danish: 2 for adjuvant.
English: • Allergic (hypersensitivity) reaction, including swelling of the face and/or lips, difficulty in breathing
Danish: • Allergisk (overfølsomheds-) reaktion, herunder hævelse af ansigt og/eller læber,
English: The recommended immunisation series consists of four doses, each of 0.5 ml.
Danish: Den anbefalede vaccinationsserie består af fire doser, hver på 0,5 ml.
English: Effect on nasopharyngeal carriage
Danish: Effekt på nasofaryngeal kolonisering
English: Prior to expelling air from the syringe, shake well to obtain a homogeneous white suspension.
Danish: Ryst grundigt, før der lukkes luft ud af kanylen, for at opnå en homogen hvid suspension.
English: Young children (12-59 months) completely immunised with Prevenar (7-valent) Young children who are considered completely immunised with Prevenar (7-valent) should receive one dose of 0.5 ml of Prevenar 13 to elicit immune responses to the 6 additional serotypes.
Danish: Børn i alderen 12-59 måneder, som er fuldt immuniseret med Prevenar (7-valent) Børn, som er fuldt immuniseret med Prevenar (7-valent), skal have 1 dosis på 0,5 ml Prevenar 13 for at fremkalde immunreaktion for yderligere 6 serotyper.
English: Based on serotype surveillance in Europe performed before the introduction of Prevenar, Prevenar 13 is estimated to cover 73-100% (depending on the country) of serotypes causing invasive pneumococcal disease (IPD) in children less than 5 years of age.
Danish: Baseret på overvågning af serotyper i Europa, som blev udført, før Prevenar blev introduceret, estimeres det, at Prevenar 13 dækker 73-100 % (afhængigt af land) af de serotyper, som forårsager invasiv pneumokoksygdom (Invasive Pneumococcal Disease (IPD)) hos børn under 5 år.
English: A fourth (booster) dose of Prevenar 13 was administered 6 months after the third dose.
Danish: En fjerde dosis (booster) Prevenar 13 blev indgivet 6 måneder efter tredje dosis.
English: In a retrospective evaluation of a large US insurance database, AOM visits were reduced by 42.7 % (95 % CI, 42.4-43.1 %), and prescriptions for AOM by 41.9 % in children younger than 2 years of age, compared with a pre-licensure baseline (2004 vs. 1997-99).
Danish: I en retrospektiv evaluering af en stor amerikansk forsikringsdatabase, blev konsultationer for AOM reduceret med 42,7 %, og medicinsk behandling for AOM med 41,9 %, hos børn under 2-års alderen, sammenlignet med en basisline fra før markedsføringstilladelse (2004 versus 1997-99).
English: Pack sizes of 1, 10 and 50, with or without needle.
Danish: Pakningsstørrelser på 1, 10 og 50, med eller uden kanyle.
English: • adults aged 18 years and older to help prevent disease such as: pneumonia (lung infection), sepsis or bacteraemia (bacteria in the blood stream) and meningitis (inflammation around the brain), caused by 13 types of the bacteria Streptococcus pneumoniae.
Danish: • voksne fra 18 år og ældre mod sygdomme såsom lungebetændelse, blodforgiftning eller bakterier i blodbanen (bakteriæmi) og meningitis (hjernehindebetændelse), forårsaget af 13 typer af bakterien Streptococcus pneumoniae.
English: Unvaccinated infants, children, and adolescents over 7 months of age
Danish: Ikke-vaccinerede spædbørn og børn over 7 måneder samt unge
English: Adults ≥ 70 years vaccinated with 23-valent pneumococcal polysaccharide vaccine at least 5 years prior
Danish: Voksne ≥ 70 år vaccineret med 23-valent pneumokok polysaccharidvaccine mindst 5 år tidligere
English: A single dose of Prevenar 13 was given to children 5 to 10 years of age previously vaccinated with at least 1 dose of Prevenar, and children and adolescents 10 to 17 years of age who had never received a pneumococcal vaccine.
Danish: Der blev givet en enkelt dosis Prevenar 13 til børn i alderen 5-10 år, som tidligere var vaccineret med mindst en dosis Prevenar samt til børn og teenagere i alderen 10-17 år, som ikke tidligere havde fået en pneumokokvaccine.
English: 7-valent Prevenar serotypes
Danish: 7-valent Prevenar serotyper
English: 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.
Danish: Hos alle voksne ≥ 50 år, som fik en enkeltdosis Prevenar 13, var OPA-titrene for serotype 6A signifikant højere end hos voksne ≥ 60 år, som fik en enkeltdosis 23-valent pneumokok polysaccharidvaccine.
English: 60-64 Years N=367-402
Danish: 60-64 år N=367-402
English: Difference (95 % CI)
Danish: Forskel (95 % CI)
English: 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
Danish: Tabel 1: Sammenligning af andelen af personer, som opnåede en pneumokok anti-polysaccharid IgG koncentration ≥ 0.35 μg/ml efter dosis 3 i spædbarnsvaccinationsserien - studie 006
English: Single Dose Vial Label
Danish: Etiket til enkeltdosishætteglas
English: Burden of disease
Danish: Sygdomsbyrde
English: Prevenar 13 may be given to adults aged 50 years and older at the same time as the trivalent or quadrivalent inactivated influenza vaccine.
Danish: Prevenar 13 kan gives til voksne over 50 år samtidig med trivalent eller tetravalent inaktiveret influenzavaccine.
English: After the infant series, OPA GMTs were similar in preterm infants compared to term infants except for serotype 5, which was lower in preterm infants.
Danish: Efter spædbørnsserien var OPA-GMT den samme hos præmature spædbørn som hos spædbørn født til terminen, bortset fra serotype 5, som var lavere hos præmature spædbørn.
English: Detailed information on this product is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: De kan finde yderligere information om Prevenar på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: • Redness, hardness, swelling at the vaccination-site of 2.5 cm -7.0 cm (after the booster dose and in older children [aged 2 to 5 years])
Danish: • Rødme, hårdhed og hævelse på 2,5 cm - 7,0 cm omkring vaccinationsstedet (efter booster-dosis og hos ældre børn [i alderen 2 til 5 år])
English: Immune responses to serotype 6A were statistically significantly greater following vaccination with Prevenar 13 than after 23-valent pneumococcal polysaccharide vaccine.
Danish: Immunresponsene på serotype 6A var statistisk signifikant større efter vaccination med Prevenar 13 end efter 23-valent pneumokok polysaccharidvaccine.
English: The immune responses to all four QIV strains were noninferior when Prevenar 13 was given concomitantly with QIV compared to when QIV was given alone.
Danish: Immunresponset på alle fire QIVstammer var non-inferiort, når Prevenar 13 blev givet samtidig med QIV, sammenlignet med QIV givet alene.
English: Children aged 12 to 23 months should receive two injections.
Danish: Børn fra 12 til 23 måneder skal have to indsprøjtninger.
English: Please speak to your doctor, pharmacist, or nurse for more information.
Danish: De kan tale med Deres læge, apotek eller sygeplejerske og få yderligere oplysninger.
English: 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)
Danish: Pyreksi > 39 °C, bevægelseshæmning på vaccinationsstedet (pga. smerter), erytem eller induration/hævelse 2,5 -7,0 cm (efter spædbørnsserien) på vaccinationsstedet
English: Children and adolescents 6 to 17 years of age should receive one injection.
Danish: Børn og unge i alderen 6-17 år skal have én indsprøjtning.
English: hardness, swelling at the vaccination-site of 2.5 cm -7.0 cm (after the initial course of injections)
Danish: hårdhed og hævelse på 2,5 cm - 7,0 cm omkring vaccinationsstedet (efter den indledende serie af injektioner)
English: The clinical significance of this is unknown.
Danish: Den kliniske betydning heraf er ukendt.
English: Studies of Prevenar 13 not containing the preservative 2-PE
Danish: Undersøgelser af Prevenar 13 uden konserveringsmidlet 2-PE:
English: Adults aged 50 years and older
Danish: Voksne over 50 år
English: 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.
Danish: Børn og unge med enten hiv-infektion, seglcelleanæmi eller bloddannende stamcelletransplantation havde tilsvarende bivirkninger, dog var hovedpine, opkastning, diarré, feber, træthed og muskel- og ledsmerter meget almindelige.
English: Children and adults with an allogeneic haematopoietic stem cell transplant (HSCT) at ≥ 2 years of age with complete haematologic remission of underlying disease or with very good partial remission in the case of lymphoma and myeloma received three doses of Prevenar 13 with an interval of at least 1 month between doses.
Danish: Børn og voksne ≥ 2 år, der har gennemgået en allogenisk hæmatopoietisk stamcelletransplantation (HSCT) og har komplet hæmatologisk remission af den underliggende sygdom eller har meget god delvis remission i tilfælde af lymfom og myelom fik tre doser Prevenar 13 med et interval på mindst 1 måned mellem doserne.
English: In both the children 5 to 10 years of age and children and adolescents aged 10 to 17 years, the immune response to Prevenar 13 was non inferior to Prevenar for the 7 common serotypes and to Prevenar 13 for the 6 additional serotypes compared to the immune response after the fourth dose in infants vaccinated at 2, 4, 6 and 12-15 months of age as measured by serum IgG.
Danish: I begge aldersgrupper, både 5-10-års-alderen og 10-17-års-alderen, var antistofresponset for Prevenar 13 non-inferiørt i forhold til Prevenar for de 7 fælles serotyper og i forhold til Prevenar 13 for de 6 yderligere serotyper sammenlignet med antistofresponset efter 4 doser hos børn vaccineret i alderen 2-, 4-, 6- og 12-15 måneder målt på serum IgG.
English: The response to serotype 6A, which is unique to Prevenar 13, was assessed by demonstration of a 4-fold increase in the specific OPA titer above pre-immunised levels.
Danish: Responset på serotype 6A, som er unikt for Prevenar 13, blev vurderet ved demonstration af en firdobbelt stigning i den specifikke OPA-titer i forhold til niveauet før immunisering.
English: • Each injection will be given at least one month apart.
Danish: • Hver indsprøjtning gives med mindst en måneds mellemrum.
English: • Hives (urticaria), redness and irritation (dermatitis) and itching (pruritus) at the vaccination-site; flushing
Danish: • Nældefeber (urtikaria), rødmen og irritation (dermatitis) og kløe (pruritus) ved vaccinationsstedet, ansigtsrødme
English: As with any vaccine, Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease.
Danish: Som for alle vacciner gælder det, at Prevenar 13 måske ikke beskytter alle de vaccinerede mod en pneumokoksygdom.
English: Prevenar 13 can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B (see section 4.4 for guidance on Infanrix hexa), meningococcal serogroup C, measles, mumps, rubella, varicella and rotavirus vaccine.
Danish: Prevenar 13 kan gives samtidig med alle følgende vaccine-antigener, enten som monovalente eller som kombinationsvacciner: difteri, tetanus, acellulær -pertussis eller helcelle-pertussis, Haemophilus influenzae type b, inaktiveret poliomyelitis, hepatitis B (se pkt.
English: Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm
Danish: Overfølsomhedsreaktion, herunder ansigtsødem, dyspnø, bronkospasmer.
English: Two-dose primary series
Danish: Primær serie med 2 doser
English: 2, 4, + 12 months
Danish: 2, 4 og 12 måneder
English: In all infant studies, Prevenar 13 was co-administered with routine paediatric vaccines (see section 4.5).
Danish: I alle studier med spædbørn blev Prevenar 13 administreret sammen med vacciner, der er almen praksis inden for børnevacciner (se pkt.
English: • Enlarged lymph nodes or glands (lymphadenopathy) near the vaccination-site, such as under the arm or in the groin
Danish: • Forstørrede lymfeknuder eller lymfekirtler (lymfadenopati) nær vaccinationsstedet, f.eks. under armen eller i lysken
English: The following frequencies are based on adverse reactions assessed in Prevenar 13 clinical studies:
Danish: De følgende hyppigheder er baseret på uønskede reaktioner, der blev vurderet i kliniske studier med Prevenar 13:
English: 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.
Danish: I et multicenter-observationsstudie i Frankrig, hvor perioderne før og efter skift fra Prevenar til Prevenar 13 blev sammenlignet, var der en reduktion på 16 % (2.060 til 1.725 tilfælde) i det samlede antal tilfælde af samfundserhvervet pneumoni (CAP) registreret på skadestuer hos børn i alderen fra 1 måned til 15 år.
English: • Hives (urticaria or urticaria-like rash)
Danish: • Udslæt (urtikaria eller urtikaria-lignende udslæt)
English: 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])
Danish: Pyreksi, irritabilitet, erytem, induration/hævelse eller smerte/ømhed på vaccinationsstedet, døsighed, dårlig søvnkvalitet Erytem eller induration/hævelse på vaccinationsstedet 2,5 -7,0 cm (efter booster-dosis og hos ældre børn [i alderen 2 til 5 år])
English: General disorders and administration site conditions: Very common:
Danish: Almene symptomer og reaktioner på administrationsstedet: Meget almindelig:
English: 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%).
Danish: I et klinisk studie med børn vaccineret i 2-, 3- og 4-måneders alderen sås feber ≥ 38 °C med en højere forekomst blandt børn, som fik Prevenar (7-valent) samtidig med Infanrix hexa (28,3-42,3 %) end hos børn, som fik Infanrix hexa alene (15,6-23,1 %).
English: One year after the second dose, antibody levels measured by both IgG GMCs and OPA GMTs were higher than levels prior to the first dose of Prevenar 13, except for the IgG GMCs for serotypes 3 and 5 that were numerically similar.
Danish: Et år efter den anden dosis var antistofniveauerne målt efter både IgG-GMC og OPA-GMT højere end niveauerne inden den første dosis Prevenar 13, undtagen for IgG-GMC for serotype 3 og 5, der nummerisk var det samme.
English: 1 dose (0.5 ml) contains approximately 32 µg CRM197 carrier protein and 0.125 mg aluminium.
Danish: 1 dosis (0,5 ml) indeholder ca. 32 µg CRM197 bærerprotein og 0,125 mg aluminium.
English: Of the Prevenar 13 recipients 1,916 adults were previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine at least 3 years prior to study vaccination, and 46,890 were 23-valent pneumococcal polysaccharide vaccine unvaccinated.
Danish: Af dem, som fik Prevenar 13, var 1.916 blevet vaccineret med 23-valent pneumokok polysaccharidvaccine mindst 3 år før studievaccinationen, og 46.890 var ikke tidligere vaccineret med 23-valent pneumokok polysaccharidvaccine.
English: Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥ 18 years of age and the elderly.
Danish: Aktiv immunisering med henblik på forebyggelse af invasiv sygdom og pneumoni forårsaget af Streptococcus pneumoniae hos voksne fra 18 år og hos ældre personer.
English: Pyrexia
Danish: Pyreksi.