FrancophonIA/ELRC3.0 huggingface dataset:
English: After the booster dose a lower percentage of subjects with OPA titres ≥ 8 was observed in the 2-dose schedule for serotypes 5 (87.2% versus 97.5% for the 3dose primed subjects) and 6B (81.1% versus 90.3%), all other responses were comparable.
Maltese: Wara d-doża booster perċentwal aktar baxx ta' individwi b'titres ta' OPA ta' ε 8 xorta kien osservat fl-iskeda ta' 2 dożi għas-serotipi 5 (87.2% versus 97.5% għal individwi li ngħataw tliet dożi) u 6B (81.1% versus 90.3%), ir-risponsi l-oħra kollha kienu jixxiebhu.
English: • In children aged 2 to 5 years that received 1 dose, the ELISA antibody GMCs were similar for 6 vaccine serotypes as well as serotype 19A than those achieved following a 3-dose vaccination schedule in infants below 6 months of age while they were lower for 4 vaccine serotypes (serotypes 1, 5, 14 and 23F).
Maltese: • Fi tfal li għandhom bejn 2 sa 5 snin, li rċevew doża waħda, il-GMCs tal-antikorpi skont ELISA kienu simili għal 6 serotipi tal-vaċċin kif ukoll għas-serotip 19A minn dawk miksuba wara skeda a' tilqim ta' 3 dożi fit-trabi ta' taħt is-6 xhur filwaqt li kienu aktar baxxi għal 4 serotipi tal-vaċċin (serotipi 1, 5, 14 u 23F).
English: Pre-filled syringe EU/1/09/508/001 EU/1/09/508/002 EU/1/09/508/003 EU/1/09/508/004 EU/1/09/508/005 EU/1/09/508/010
Maltese: EU/1/09/508/001 EU/1/09/508/002 EU/1/09/508/003 EU/1/09/508/004
English: Pneumococcal polysaccharide serotype 41,2
Maltese: Polysaccharide pnewmokokkali serotip 41,2
English: In comparative clinical studies, the incidence of local and general adverse events reported within 4 days after each vaccination dose was within the same range as after vaccination with 7-valent Prevenar.
Maltese: Fi studji kliniċi komparattivi, l-inċidenza ta' avvenimenti avversi lokali u ġenerali rrapportati sa 4t ijiem wara kull doża ta' tilqim kienu fl-istess firxa bħal dik wara tilqim b'Prevenar 7-valenti .
English: In subjects that had received a 3-dose primary series followed by a booster dose, at least 96.5% of the subjects remained seropositive for vaccine serotypes and 86.4% for serotype 19A.
Maltese: F'individwi li kienu ħadu s-serje ta' tilqim primarju bi tliet dożi segwit minn doża booster mill-anqas 96.5% tal-individwi baqgħu seropożittivi għas-serotipi tat-tilqima u 86.4% għas-serotip 19A.
English: See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.
Maltese: Ara sezzjonijiet 4.4 u 5.1 għal tagħrif dwar protezzjoni kontra serotipi speċifiċi ta' pnewmokokki.
English: The percentage of subjects with OPA titres ≥ 8 in 2-dose primed subjects compared to 3-dose primed subjects were lower for serotypes 6B, 18C and 23F (74.4%, 82.8%, 86.3% respectively for the 2-dose schedule and 88.9%, 96.2%, 97.7% respectively for the 3-dose schedule).
Maltese: Il-perċentwal ta' individwi b'titres ta' OPA ta' ε 8 f'individwi li jkunu ngħataw żewġ dożi mqabbla ma' individwi li jkunu ngħataw 3 dożi kien aktar baxx għas serotipi 6B, 18C u 23F (74.4%, 82.8%, 86.
English: Effectiveness following catch-up immunisation
Maltese: Effikaċja wara tilqim ta' wara l-età rakkomandata catch-up immunization
English: Pre-booster GMCs (8 to 12 months after the last primary dose) were generally similar for the two vaccines.
Maltese: GMCs qabel il-booster (8 sa 12-il xahar wara l-aħħar doża primarja) ġeneralment kienu simili għaż-żewġ tilqimiet.
English: 92.7% of subjects achieved ELISA antibody concentrations ≥ 0.20 µg/ml and at least 81.7% achieved OPA titres ≥ 8 except serotype 1 (at least 58.8% with OPA titres ≥ 8).
Maltese: Xahar wara t-tilqim primarju (jiġifieri wara t-tielet doża), għal kull serotip tal-vaċċin mill-anqas 92.7% tal-individwi kisbu konċentrazzjonijiet ta' antikorpi mkejla b'ELISA ≥ 0.20 µg/ml u mill anqas 81.7% kisbu titres ta' OPA ta' ≥ 8, minbarra għas-serotip 1 (mill-anqas 58.8% b'titres ta' OPA ta' ≥ 8).
English: (2) the 2 groups of control clusters of infants were pooled (3) p-value<0.0001 (4) p-value=0.0009
Maltese: (2) iż-żewġ gruppi ta' raggruppamenti ta' kontroll inġabru flimkien (3) valur p<0.0001 (4) valur p=0.0009 (5) fil-koorti tal-ATP il-VE kienet ta' 100% (95% CI: 74.3;100; 0 kontra 16-il każ)
English: In the interim analysis (ATP cohort), the vaccine efficacy against first episodes of CAP with alveolar consolidation or pleural effusion (C-CAP, WHO definition) was 25.7% (95% CI: 8.4; 39.6) and against first episodes of clinically suspected CAP referred for X-ray was 6.7% (95% CI: 0.7; 12.3).
Maltese: 7% (95% CI: 8.4; 39.6) u kontra l-ewwel episodji ta' CAP suspettata klinikament riferuta għal raġġi X kienet 6.7% (95% CI: 0.7; 12.3).
English: 50 doses (0.5 ml)
Maltese: 4 dożi (0.5 ml/doża)
English: Clinical data suggest that prophylactic administration of paracetamol, used to reduce the rate of possible post-vaccination febrile reactions, might reduce the immune response to Synflorix.
Maltese: Dejta klinika tissuġġerixxi li l-għoti profilattiku ta' paracetamol, li jintuża biex inaqqas ir-rata ta' reazzjonijiet ta' deni possibbli wara t-tilqima, jista' jnaqqas ir-rispons immuni għal Synflorix.
English: • allergic reactions such as skin allergies
Maltese: • reazzjonijiet allerġiċi bħal allerġiji fil-ġilda
English: Furthermore, 19,466 children and 116 preterm infants received a booster dose of Synflorix in the second year of life.
Maltese: Barra dan, 19,466 tifel u tifla u 116-il tarbija li twieldet qabel iż-żmien irċevew doża booster ta' Synflorix fit-tieni sena ta' ħajja.
English: Results suggest comparable reactogenicity and safety profile of Synflorix between these high risk groups and healthy children.
Maltese: Ir-riżultati jissuġġerixxu reaktoġeniċità komparabbli u profil tas-sigurtà ta' Synflorix bejn dawn iżżewġ gruppi ta' riskju għoli u tfal b'saħħithom.
English: Fever ≥ 38 °C rectally (age 2 to 5 years) Uncommon Fever > 40 °C rectally (age < 2 years), fever > 39 °C rectally (age 2 to 5 years), injection site reactions like diffuse swelling of the injected limb, sometimes involving the adjacent joint, pruritus.
Maltese: Deni > 40 °C fir-rektum (< sentejn), deni > 39 °C fir-rektum (sentejn sa ħames snin), reazzjonijiet fil-post tal-injezzjoni bħal nefħa mifruxa tal-parti injettata, li xi drabi taffettwa lill-ġog biswit, ħakk.
English: In addition when the meningococcal serogroups A, C, W-135 and Y vaccine (TT conjugate) was coadministered with a booster dose of Synflorix during the second year of life in children primed with 3 doses of Synflorix, lower antibody geometric mean concentration (GMC) and opsonophagocytic assay geometric mean titre (OPA GMT) were observed for one pneumococcal serotype (18 C).
Maltese: Barra minn hekk, meta s-serogruppi meningokokkali A, C, W-135 u l-vaċċin Y (konjugat ta' TT) ingħataw flimkien ma' doża booster ta' Synflorix fit-tieni sena tal-ħajja fi tfal li kienu ngħataw 3 dożi ta' Synflorix, ġie osservat tnaqqis fil-konċentrazzjoni ġeometrika medja (GMC) u fit-titri ġeometriċi medji tal-analiżi opsonofagoċitika (GMT OPA) tal-antikorpi għal serotip pnewmokokkali wieħed (18 C).
English: The functional immune response to serotypes 1 and 5 was lower in magnitude than the response against all other vaccine serotypes.
Maltese: Ir-rispons immuni funzjonali għal serotipi 1 u 5 kien inqas qawwi mir-rispons kontra s-serotipi tal-vaċċin l-oħra kollha.
English: Type or cause of AOM
Maltese: Tip jew kawża ta' AOM
English: For serotypes 6B and 23F, respectively, 65.9% and 81.4% of infants vaccinated at 2, 3 and 4 months reached the antibody threshold (i.e. 0.20 µg/ml) one month after the third dose of Synflorix versus 79.0% and 94.1% respectively, after three doses of 7-valent Prevenar.
Maltese: 4% tat-trabi mlaqqma fl-età ta' 2, 3 u 4 xhur laħqu l-limitu ta' antikorpi (jigifieri 0.20 µg/ml) xahar wara t-tielet doża ta' Synflorix kontra 79.0% u 94.
English: Based on 1.5 years of surveillance following Synflorix introduction, with over 90% coverage in the vaccine-eligible age group, a decrease in vaccine serotype IPD incidence (largely due to changes in serotype 7F disease) was observed with no concomitant increase in non-vaccine serotype IPD incidence.
Maltese: Fuq il-bażi ta' 1.5 snin ta' sorveljanza wara l-introduzzjoni ta' Synflorix, b'kopertura ta' aktar minn 90% fil-grupp ta' età eliġibbli għall-vaċċin, kien osservat tnaqqis fl-inċidenza ta' IPD mis-serotipi talvaċċin (l-aktar minħabba bidliet fil-mard tas-serotip 7F) mingħajr l-ebda żieda konkomitanti flinċidenza ta' IPD mhux mis-serotipi tal-vaċċin.
English: Post-primary and post-booster OPA antibody geometric mean titres (GMTs) elicited by Synflorix were lower than those elicited by 7-valent Prevenar for the seven shared serotypes, except for serotype 19F.
Maltese: Wara d-doża booster il-GMCs li rriżultaw minn Synflorix kienu inqas għallmaġġoranza ta' serotipi komuni ma' Prevenar 7-valenti.
English: In addition, as otitis media and pneumonia are caused by many microorganisms other than the Streptococcus pneumoniae serotypes represented by the vaccine, the overall protection against these diseases is expected to be limited and substantially lower than protection against invasive disease caused by the serotypes in the vaccine and serotype 19A (see section 5.1).
Maltese: Barra minn hekk, peress li s-serotipi ta' Streptococcus pneumoniae irrappreżentati bit-tilqima otite medja u pnewmonja huma kkawżati minn ħafna mikro-organiżmi oħra, il-protezzjoni globali kontra dan il-mard hija mistennija li tkun limitata u sostanzjalment inqas mill-protezzjoni kontra mard invażiv ikkawżat mis-serotipi fil-vaċċin u fisserotip 19A (ara sezzjoni 5.1)
English: In COMPAS, serotypes 5 (2 cases), 18C (4 cases) and 23F (1 case) were detected in control group in addition to serotypes 6B and 14.
Maltese: F'COMPAS, minbarra s serotipi 6B u 14, fil-grupp tal-kontroll instabu s-serotipi 5 (2 każijiet), 18C (4 każijiet) u 23F
English: Synflorix suspension for injection in pre-filled syringe Synflorix suspension for injection Synflorix suspension for injection in multidose container (2 doses) Synflorix suspension for injection in multidose container (4 doses)
Maltese: Synflorix suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Synflorix suspensjoni għall-injezzjoni
English: In individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as Human Immunodeficiency Virus (HIV) infection, sickle cell disease (SCD) or splenic dysfunction), Synflorix may be given according to the above mentioned schedules except that a 3-dose schedule should be given as primary vaccination in infants starting vaccination from 6 weeks to 6 months of age (see sections 4.4 and 5.1).
Maltese: F'individwi li għandhom kundizzjonijiet sottostanti li jippredisponuhom għal marda pnewmokokkali invażiva (bħall- infezzjoni tal-Virus tal-Immunodefiċjenza Umana (HIV, Human Immunodeficiency Virus), marda sickle cell (SCD, sickle-cell disease) jew disfunzjoni tal-milsa), Synflorix jista' jingħata skond l-iskedi msemmija hawn fuq ħlief li skeda ta' 3 dożi li għandha tingħata bħala vaċċinazzjoni primarja fi trabi li jibdew il-vaċċinazzjoni minn età ta' 6 ġimgħat sa 6 xhur (ara sezzjonijiet 4.4 u 5.1):
English: Post-marketing experience Immune system disorders
Maltese: Disturbi fis-sistema immuni
English: Anaphylaxis
Maltese: Invażiv
English: Post-primary
Maltese: Wara t-tilqim primarju
English: Pack size of 100.
Maltese: Daqs tal-pakkett ta' 10 jew 100.
English: Immunogenicity of Synflorix containing the preservative 2-PE (presented in a 4-dose container) was assessed in healthy infants vaccinated at 6, 10 and 18 weeks of age and compared to those receiving Synflorix without added preservative (160 enrolled subjects per group).
Maltese: L-immunoġeniċità ta' Synflorix li fih il-preservattiv 2-PE (ippreżentat f'kontenitur ta' 4 dożi) ġiet ivvalutata fi trabi b'saħħithom imlaqqma f'età ta' 6, 10 u 18-il ġimgħa u mqabbla ma' dawk li jiċievu Synflorix mingħajr preservattiv miżjud (160 individwu rreġistrat kull grupp).
English: Clinical trials Immune system disorders
Maltese: Esperjenza ta' wara t-tqegħid fis-suq Disturbi fis-sistema immuni
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL, PACK OF 1, 10, 100
Maltese: DOŻI), PAKKETT TA' 10, 100
English: Multidose vial For storage conditions after first opening of the medicinal product, see section 6.3.
Maltese: Għal kundizzjonijiet ta' ħżin wara l-ewwel ftuħ tal-prodott mediċinali, ara sezzjoni 6.3.
English: In Quebec, Canada, Synflorix was introduced into the infant immunisation programme (2 primary doses to infants less than 6 months of age and a booster dose at 12 months) following 4.5 years of use of 7-valent Prevenar.
Maltese: Fi Quebec, il-Kanada, Synflorix iddaħħal fil-programm ta' tilqim tat-trabi (2 dożi primarji lil trabi ta' taħt is-6 xhur u doża booster meta jkollhom 12-il xahar) wara 4.5 snin ta' użu ta' Prevenar 7-valenti.
English: Only HIV+/+ infants with WHO classification stage 1 (asymptomatic) or 2 (mild symptoms) were to be enrolled.
Maltese: Kellhom jiġu rreġistrati biss trabi HIV+/+ bi stadju 1 (asintomatiċi) jew 2 (sintomi ħfief) tal-klassifikazzjozni ta' WHO.
English: 1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (butyl rubber).
Maltese: Kunjett b'aktar minn doża waħda 1 ml ta' suspensjoni f'kunjett (ħġieġ ta' tip I) għal 2 dożi b'tapp (butyl rubber).
English: Safety and immunogenicity data are available for HIV infected infants (asymptomatic or with mild symptoms according to WHO classification), HIV negative infants born from HIV positive mothers, children with sickle cell disease and children with splenic dysfunction (see sections 4.8 and 5.1).
Maltese: Hi disponibbli dejta dwar sigurtà u immunoġeniċità għal trabi infettati bl-HIV (asintomatika u b'sintomi ħfief skont il-klassifikazzjoni ta' WHO), għal trabi li huma negattivi għall-HIV li twieldu minn ommijiet pożittivi għall-HIV, għal tfal bil-marda sickle cell u għal tfal b'disfunzjoni tal-milsa (ara sezzjonijiet 4.8 u 5.1).
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Maltese: Synflorix suspensjoni għall-injezzjoni Vaċċin konjugat (adsorbit) ta' polysaccharide pnewmokokkali
English: Pneumonia of different aetiologies is a leading cause of childhood morbidity and mortality globally.
Maltese: Il-pnewmonja ta' etjoloġiji differenti hija l-kawża ewlenija tal-morbiditajiet fit-tfulija u l-mortalità fuq livell globali.
English: In the catch-up cohorts, children between 7-11 months of age at first vaccine dose received Synflorix or hepatitis B control vaccine according to a 2-dose primary schedule followed by a booster dose and children between 12-18 months of age at first vaccine dose received 2 doses of either Synflorix or hepatitis A control vaccine.
Maltese: Fil-koorti ta' ‘catchup', it-tfal ta' bejn 7 u 11-il xahar fl-ewwel doża ta' tilqima ngħataw Synflorix jew it-tilqima ta' kontroll tal-epatite B skont skeda primarja ta' 2 dożi segwita minn doża booster u t-tfal ta' bejn 12 u 18-il xahar fl-ewwel doża ta' tilqima ngħataw 2 dożi ta' Synflorix jew it-tilqima ta' kontroll tal-epatite A.
English: The proportion of subjects with an ELISA antibody concentration ≥ 0.20 µg/ml or an
Maltese: Differenza f'% ta' ≥ 0.20µg/ml
English: In a clinical study, it has been demonstrated that Synflorix can be safely administered as a booster dose in the second year of life to children who had received 3 primary doses of 7-valent Prevenar.
Maltese: Fi studju kliniku, intwera li Synflorix jista' jingħata b'mod sikur bħala doża booster fit-tieni sena ta' ħajja lil tfal li kienu rċevew 3 dożi primarji ta' Prevenar 7-valenti.
English: Anti-1 97.4 Anti-4 98.0 Anti-5 96.1 Anti-6B 55.7 Anti-7F 96.7 Anti-9V 93.4 Anti-14 96.1 Anti-18C 96.1 Anti-19F 92.8 Anti-23F 69.3
Maltese: Anti-5 96.1 Anti-6B 55.7 Anti-7F 96.7 Anti-9V 93.4
English: However, the clinical relevance of this observation is not known.
Maltese: Madankollu, ir-rilevanza klinika ta' din l-osservazzjoni mhix magħrufa.
English: • Each injection will be given at least one month apart except for the last injection (booster),
Maltese: • Kull injezzjoni se tingħata b'interval ta' mill-inqas xahar minbarra l-aħħar injezzjoni (booster),
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection in multidose container (4 doses) Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Maltese: Synflorix suspensjoni għall-injezzjoni f'kontenitur b'aktar minn doża waħda (4 dożi) Vaċċin konjugat (adsorbit) ta' polysaccharide pnewmokokkali
English: In the second clinical study, a single dose administered four months after two catch-up doses at 12-20 months of age elicited a marked increase of ELISA GMCs and OPA GMTs (when comparing the responses pre and post the last dose), indicating that two catch-up doses provide adequate priming.
Maltese: Fit-tieni studju kliniku, doża waħda mogħtija erba' xhur wara żewġ dożi catch-up fi12-20 xahar ta' età laħqet żieda notevoli ta' ELISA GMCs u OPA GMTs (meta mqabbel mar-risponsi qabel u wara laħħar doża), li jindika li żewġ dożi catch-up jipprovdu tħejjija adegwata.
English: The third clinical study showed that the administration of 2 doses with a 2 month interval starting at 36-46 months of age resulted in higher ELISA antibody GMCs and OPA GMTs than those observed one month after a 3-dose primary vaccination for each vaccine serotype and the cross-reactive serotype 19A.
Maltese: -It-tielet studju kliniku wera li l-għoti ta' 2 dożi b'intervall ta' xaharejn li jibda minn 36-46 xahar irriżulta f'GMCs tal-antikorpi skont ELISA u GMTs skont OPA ogħla minn dawk osservati xahar wara tilqima primarja ta' 3 dożi għal kull serotip ta' vaċċin u għas-serotip kross-reattiv 19A.
English: Enhancement of antibody response to Hib-TT conjugate, diphtheria and tetanus antigens was observed.
Maltese: Kien osservat titjib tar-rispons ta' l-antikorpi għall-antiġeni tal-konjugat ta' Hib-TT, tad-difterite u tat-tetnu.
English: Children from 6 weeks up to 5 years of age considered to be at a higher risk of pneumococcal infection (such as those with HIV infection, sickle cell disease or impaired or abnormal functioning of the spleen) may receive Synflorix.
Maltese: Tfal minn età ta' 6 ġimgħat sa 5 snin li jitqiesu li għandhom riskju ogħla li jkollhom infezzjoni pnewmokokkali (bħal dawk b'infezzjoni tal- HIV, bil-marda sickle cell jew b'funzjonament indebolit jew anormali tal-milsa) jistgħu jirċievu Synflorix.
English: Clinical studies demonstrated that the immune responses and the safety profiles of the co-administered vaccines were unaffected, with the exception of the inactivated poliovirus type 2 response, for which inconsistent results were observed across studies (seroprotection ranging from 78% to 100%).
Maltese: Studji kliniċi wrew li r-rispons immuni u l-profili ta' sigurtà tat-tilqim li ngħata flimkien ma kienux affettwati, bl-eċċezzjoni tar-rispons tal-poljovirus inattivat tip 2, għal-liema kienu osservati riżultati mhux konsistenti waqt l-istudji (seroprotezzjoni li tvarja minn 78% sa 100%).
English: Table 7: Percentage of 2-dose primed subjects with antibody concentrations ≥ 0.20 µg/ml one month post-primary and one month post-booster Antibody
Maltese: Perċentwal ta' individwi mlaqqma b'2 dożi b'konċentrazzjonijiet ta' antikorpi ta' ≥ 0.20 µg/ml xahar wara t-tilqim primarju u xahar wara t-tilqima booster
English: Unvaccinated infants and children ≥ 7 months of age:
Maltese: Trabi u tfal mhux imlaqqma ta' ≥ 7 xhur:
English: However, in TVC
Maltese: U L-UŻU
English: • The other ingredients are: sodium chloride (see section 2 for further information), 2-phenoxyethanol and water for injections
Maltese: • Is-sustanzi l-oħra huma: sodium chloride (ara sezzjoni 2 għal aktar informazzjoni) u ilma għall injezzjonijiet
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in multidose container (4 doses) 10 MULTIDOSE vials (4 doses per vial - 0.5 ml per dose) 100 MULTIDOSE vials (4 doses per vial - 0.5 ml per dose)
Maltese: B'AKTAR MINN DOŻA WAĦDA (4 dożi kull kunjett - 0.5 ml kull doża)
English: In a large-scale phase III/IV, double-blind, cluster-randomized, controlled, clinical trial in Finland (FinIP), children were randomised into 4 groups according to the two infant vaccination schedules [2-dose (3, 5 months of age) or 3-dose (3, 4, 5 months of age) primary schedule followed by a booster dose as of 11 months of age] to receive either Synflorix (2/3rd of clusters) or hepatitis vaccines as control (1/3rd of clusters).
Maltese: Fi prova klinika fuq skala kbira, bi blindaġġ doppju, b'raggruppamenti randomizzati u kkontrollata talfażi III/IV li saret fil-Finlandja (FinIP), it-tfal kienu randomizzati f'4 gruppi skont iż-żewġ skedi ta' vaċċinazzjoni tat-trabi [2-dożi (fit-3, 5 xahar) jew l-iskeda primarja ta' 3-dożi (fit-3, 4, 5 xahar) segwita minn doża booster mill-11-il xahar] sabiex jirċievu jew Synflorix (żewġ terzi tarraggruppamenti) jew vaċċini tal-epatite bħala kontroll (terz tar-raggruppamenti).
English: In the follow-up of the European study evaluating the 2-dose and 3-dose primary vaccination schedules, the persistence of antibodies at 36-46 months of age was demonstrated in subjects that had received a 2-dose primary series followed by a booster dose with at least 83.7% of subjects remaining seropositive for vaccine serotypes and the cross-reactive serotype 19A.
Maltese: Fis-segwitu tal-istudju Ewropew li jevalwa l-iskedi ta' vaċċinazzjoni primarja b'2 dożi u bi 3 dożi, ilpersistenza tal-antikorpi fl-età ta' 36-46 xahar intweriet f'individwi li kienu ħadu s-serje ta' tilqim primarju b'żewġ dożi segwita minn doża booster b'tal-anqas 83.7% tal-individwi jibqgħu pożittivi għas-serotipi tal-tilqima u s-serotip kross-reattiv 19A.
English: LIST OF EXCIPIENTS Sodium chloride Water for injections
Maltese: Sodium chloride Ilma għall-injezzjonijiet
English: Effectiveness against physician-diagnosed AOM reported by parents was studied in the nested study within the FinIP trial.
Maltese: L-effikaċja kontra AOM dijanjostikata minn tabib irrappurtata mill-ġenituri ġiet studjata fl-istudju nested fil-prova FinIP.
English: Alternatively, when Synflorix is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5 ml may be given.
Maltese: Inkella, meta Synflorix jingħata bħala parti minn programm ta' tilqim ta' rutina tat-trabi, tista' tingħata serje li tikkonsisti fi tliet dożi, ta' 0.5 ml il-waħda.
English: Although there was no significant difference between the two groups in the percentages of subjects with antibody concentration ≥ 0.20 µg/ml (ELISA), the percentages of subjects for serotypes 6B and 23F were lower than for the other vaccine serotypes (Table 7 and Table 8).
Maltese: Għalkemm ma kienx hemm differenza sinifikanti bejn iż-żewġ gruppi filperċentwali ta'individwi b'konċentrazzjoni ta' antikorpi ta' ε 0.20 g/ml (ELISA), il-perċentwali ta' individwi għas-serotipi 6B u 23F kienu aktar baxxi minn dawk għal serotipi tal-vaċċin oħrajn (Tabella 7 u Tabella 8).
English: (4) Individual serotypes for which statistical significance was reached in the effectiveness analysis controlling for confounding factors (no adjustment for multiplicity performed).
Maltese: (4) Serotipi individwali li għalihom intlaħaq sinifikat statistiku fl-analiżi tal-effikaċja li tikkontrolla għal fatturi konfondenti (ma twettaq l-ebda aġġustament għall-multipliċità).
English: Immunogenicity of Synflorix in very preterm (gestation period of 27-30 weeks) (N=42), preterm (gestation period of 31-36 weeks) (N=82) and full term (gestation period > 36 weeks) (N=132) infants was evaluated following a 3-dose primary vaccination course at 2, 4, 6 months of age.
Maltese: (N=42), qabel iż-żmien (perijodu ta' tqala ta' 31-36 ġimgħa) (N=82) u fi żmienhom (perijodu ta' tqala ta' > 36 ġimgħa) (N=132) kienu evalwati wara kors ta' tilqim primarju bi 3 dożi fletajiet ta' xahrejn, 4 u 6 xhur.
English: The results were not statistically significant across all analyses in COMPAS.
Maltese: Irriżultati ma kinux statistikament sinifikanti fl-analiżi kollha f'COMPAS.