FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are reported as: Very common: (≥1/10) Common:
Maltese: Komuni ħafna: (≥ 1/10) Komuni:
English: Synflorix schedule
Maltese: Synflorix skeda
English: In infants, the most common adverse reactions observed after primary vaccination were redness at the injection site and irritability which occurred after approximately 41% and 55% of all doses respectively.
Maltese: Fit-trabi, l-aktar reazzjonjiet avversi komuni osservati wara tilqim primarju kienu ħmura talinjezzjoni u irritabilità li seħħew wara madwar 41% u 55% tad-dożi kollha rispettivament.
English: LIST OF EXCIPIENTS Sodium chloride 2-phenoxyethanol Water for injections
Maltese: Sodium chloride 2-phenoxyethanol Ilma għall-injezzjonijiet
English: Pneumococcal polysaccharide serotype 19F1,4
Maltese: Polysaccharide pnewmokokkali serotip 19F1,4
English: Vaccine effectiveness was 6.1% (95% CI: -2.7; 14.1) for the 3+1 schedule and 7.4% (95% CI -2.8; 16.6) for 2+1 schedule for this AOM endpoint in the infant vaccinated cohort.
Maltese: L-effettività tal-vaċċin kienet ta' 6.1% (95% CI: -2.7; 14.1) għall-iskeda 3+1 u ta' 7.4% (95% CI -2.8; 16.6) għall-iskeda 2+1 għal dan l-endpoint tal-AOM fil-koorti ta' trabi vvaċċinati.
English: • Kawasaki disease (major signs of the illness are for instance: fever, skin rash, swollen lymph glands, inflammation and rash of the mucous membranes of the mouth and throat)
Maltese: • Marda ta Kawasaki(sinjali magguri ta mard huma per ezempju: deni, raxx tal-gilda, nefha filglandoli, infjammazzjoni u raxx tal membrani mukozi tal-halq u l-gerzuma).
English: 10 vials 10 x 1 dose (0.5 ml)
Maltese: 10 kunjetti 10 x 1 dożi (0.5 ml)
English: CI Confidence Interval
Maltese: Intervall ta' Fiduċja
English: cohort, vaccine efficacy against first clinical AOM episode was 19% (95% CI: 4.4; 31.4).
Maltese: Madanakollu, fil-koorti tat-TVC, l-effikaċja tal-vaċċin kontra l-ewwel episodju ta' AOM klinika kienet ta' 19% (95% CI: 4.4;31.4). (4)
English: For each of the seven serotypes in common, 87.7% to 100% of Synflorix vaccinees and 92.1% to 100% of 7-valent Prevenar vaccinees reached an OPA titre ≥ 8 one month after the third dose.
Maltese: Xahar wara t-tielet doża 87.7% sa 100% tat-tilqim ta' Synflorix u 92.1% sa 100% tat-tilqim ta' Prevenar 7-valenti laħqu titre ta' OPA ta' ε 8 għal kull wieħed mis-seba' serotipi komuni.
English: It is used to help protect your child from 6 weeks up to 5 years of age against: a bacteria called ‘Streptococcus pneumoniae'.
Maltese: Jintuża biex jgħin jipproteġi lit-tifel/tifla tiegħek ta' età minn 6 ġimgħat sa 5 snin kontra: batterja msejħa ‘Streptococcus pneumoniae'.
English: After the primary vaccination course, fever ≥38 °C and >39 °C was reported respectively in 86.1% and 14.7% of children receiving Synflorix and in 82.9% and 11.6% of children vaccinated with 7-valent Prevenar.
Maltese: Wara l-kors ta' tilqim primarju, kien irrapportat deni ta' ≥38°C u >39°C rispettivament f'86.1% u 14.7% tat-tfal li rċevew Synflorix u f'82.9% u 11.6% tat-tfal imlaqqma b'Prevenar 7valenti.
English: 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.
Maltese: Intwera wkoll li Synflorix jinduċi rispons immuni għas-serotip kross-reattiv 19A b'48.8% (95% CI: 42.9;54.7) tal-vaċċini li jilħqu titru OPA > 8 xhur wara doża booster.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains:
Maltese: U KWANTITATTIVA Doża waħda (0.5 ml) fiha:
English: In another large randomised double-blind trial (POET) conducted in the Czech Republic and in Slovakia, 4,907 infants (ATP cohort) received either the 11-valent investigational vaccine (11Pn-PD) containing the 10 serotypes of Synflorix (along with serotype 3 for which efficacy was not demonstrated) or a control vaccine (hepatitis A vaccine) according to a 3, 4, 5 and 12-15 months vaccination schedule.
Maltese: Fi prova oħra kbira, randomised u double-blind (POET) li twettqet fir-Repubblika Ċeka u flIslovakkja, 4,907 trabi (koorti tal-ATP) irċevew jew it-tilqima 11-valent taħt investigazzjoni (11PnPD) li kien fiha l-10 serotipi ta' Synflorix (flimkien ma' serotip 3 li għalih l-effikaċja ma ġietx dimostrata) jew tilqima ta' kontroll (tilqim ta' l-epatite A) skond skeda ta' tilqim ta' 3, 4, 5 u 12-15-il xahar.
English: 10 pneumococcal vaccine serotypes
Maltese: 10 serotipi tal-vaċċin pnewmokokkali
English: Pharmacotherapeutic group: vaccines, pneumococcal vaccines, ATC code: J07AL52
Maltese: .1 Proprjetajiet farmakodinamiċi Kategorija farmakoterapewtika: tilqim, tilqim pnewmokokkali, Kodiċi ATC:
English: Post-booster
Maltese: Wara t-tilqima booster
English: After NIP
Maltese: NIP
English: • Suspension for injection
Maltese: • Suspensjoni għall-injezzjoni
English: Efficacy against any AOM episode due to any pneumococcal serotype was 51.5% (95% CI: 36.8; 62.9).
Maltese: Leffikaċja kontra kull episodju ta' AOM minħabba kull serotip pnewmokokkali kienet 51.5% (95% CI: 36.8; 62.9).
English: 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:
Maltese: L-ewwel studju kliniku vvaluta r-rispons immuni għas-serotipi tal-vaċċin u għas-serotip kross-reattiv 19A fi tfal b'età minn 7-11-xahar, minn 12-23 xahar u minn 2 sa 5 snin:
English: EU/1/09/508/007 - pack of 10
Maltese: EU/1/09/508/007 - pakkett ta' 10
English: • high temperature of 38° C or higher (fever)
Maltese: • temperature għolja ta' 38°C jew ogħla (deni)
English: The vaccine efficacy against the first episode of NTHi AOM was 31.1% (95% CI: -3.7; 54.2, not significant).
Maltese: L-effikaċja tal-vaċċin kontra l-ewwel episodju ta' NTHi AOM kienet ta' 31.1% (95% CI: -3.7; 54.2, mhux sinifikanti).
English: • Synflorix is a turbid white suspension.
Maltese: • Synflorix hija suspensjoni bajda, mdardra.
English: Clinical data generated with paracetamol and ibuprofen suggest that the prophylactic use of paracetamol might reduce the fever rate, while prophylactic use of ibuprofen showed a limited effect in reducing fever rate.
Maltese: Dejta klinika ġġenerata b'paracetamol u ibuprofen tissuġġerixxi li l-użu profilattiku ta' paracetamol jista' jnaqqas ir-rata ta' deni, filwaqt li l-użu profilattiku ta' ibuprofen wera effett limitat fit-tnaqqis tar-rata ta' deni.
English: 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).
Maltese: L-effett ta' Synflorix fuq il-ġarr nażofarinġeali ġie studjat f'2 studji randomizzati bi blindaġġ doppju li użaw kontroll inattivi: fl-istudju nested ta' FinIP fil-Finlandja (5023 individwu) u f'COMPASS (1,700 individwu).
English: In clinical studies the immunogenicity of Synflorix was evaluated after a 3-dose primary vaccination series (6941 subjects) according to different schedules (including 6-10-14 weeks, 2-3-4, 3-4-5 or 2-4-6 months of age) and after a fourth (booster) dose (5645 subjects) given at least 6 months after the last primary dose and from the age of 9 months onwards.
Maltese: Fi studji kliniċi, l-immunoġeniċità ta' Synflorix ġiet evalwata wara serje ta' tilqim primarju ta' 3 dożi (N=6941 individwu) skont skedi differenti (inkluż età ta' 6-10-14-il ġimgħa, 2-3-4, 3-4-5 jew 2-46 xhur) u wara r-raba' doża (booster) (5645 individwu) li ngħatat tal-inqas 6 xhur wara l-aħħar doża primarja u minn età ta' 9 xhur 'il quddiem.
English: In Finland, Synflorix was introduced into NIP with a 2+1 schedule in infants (3, 5 months of age and a booster dose at 12 months) without catch-up campaign.
Maltese: Fil-Finlandja, Synflorix kien introdott f'NIP bi skeda 2+1 fi trabi (li għandhom 3, 5 xhur u doża booster fi 12-il xahar) mingħajr kampanja catch-up.
English: 7-valent Prevenar Difference in % ≥ 0.20µg/ml (7valent Prevenar minus Synflorix)
Maltese: (Prevenar 7-valenti mingħajr Synflorix)
English: EU/1/09/508/008 - pack of 100
Maltese: EU/1/09/508/008 - pakkett ta' 100
English: 2 ml of suspension in a vial (type I glass) for 4 doses with a stopper (butyl rubber).
Maltese: 2 ml ta' suspensjoni f'kunjett (ħġieġ ta' tip I) għal 4 dożi b'tapp (butyl rubber).
English: Infants from 6 weeks to 6 months of age
Maltese: Trabi b'età minn 6 ġimgħat sa 6 xhur
English: 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.
Maltese: Il-valutazzjoni tas-sigurtà ta' Synflorix kienet ibbażata fuq il-provi kliniċi li kienu jinvolvu l-għoti ta' 63,905 dożi ta' Synflorix lil 22,429 tifel u tifla b'saħħithom u 137 tarbija li twieldet qabel iżżmien bħala tilqima primarja.
English: The estimated vaccine efficacy against any clinical episodes of otitis media regardless of aetiology was 33.6% (95% CI: 20.8;
Maltese: L-effikaċja stmata tat-tilqima kontra kull episodju kliniku ta' otite medja ta' kull etjoloġija kienet 33.6% (95% CI: 20.8; 44.3).
English: Any pneumococcal serotype
Maltese: Kull serotip pnewmokokkali
English: Pneumococcal polysaccharide serotype 23F1,2
Maltese: Polysaccharide pnewmokokkali serotip 23F1,2
English: • Synflorix is available in vials for 2 doses in a pack of 100.
Maltese: • Synflorix huwa disponibbli f'kunjetti għal żewġ dożi f'pakkett ta' 100.
English: However, children who received 7-valent Prevenar for the primary series would not be primed against the additional serotypes contained in Synflorix (1, 5, 7F).
Maltese: Madankollu, tfal li rċevew Prevenar 7-valenti għas-serje primarja ma jkunux indotti kontra s-serotipi addizzjonali li hemm f'Synflorix (1, 5, 7F).
English: For the cross-reactive serotype 19A, similar percentages of subjects reaching antibody threshold and OPA titres ≥ 8 and similar antibody GMC and OPA GMT were observed post-primary in both groups.
Maltese: Għas-serotip kross-reattiv 19A, fiż-żewġ gruppi, ġew osservati perċentwali simili ta' individwi li ssodisfaw il-limitu ta' antikorpi u titres ta' OPA ε 8 u l-GMC ta' antikorp u l-GMT ta' OPA simili wara t-tilqim primarju.
English: For most vaccine serotypes, group comparisons did not suggest any differences in post-primary immune responses between the HIV+/+ and HIV-/- groups, or the HIV+/- and HIV-/- groups, except for a trend towards a lower percentage of subjects reaching OPA titres ≥ 8 and lower OPA GMTs in the HIV+/+ group.
Maltese: Għal ħafna mis-serotipi tal-vaċċin, it-tqabbil bejn il-gruppi ma ssuġġerixxiex xi differenza fir-rispons immuni wara t-tilqim primarju bejn il-gruppi HIV+/+ u HIV-/-, jew il-gruppi HIV+/- u HIV-/-, ħlief għat-tendenza lejn perċenwal aktar baxx ta' individwi li jissodisfaw titres ta' OPA ≥ 8 u l-GMTs ta' OPA aktar baxxi fil-grupp HIV+/+.
English: Pneumococcal polysaccharide serotype 7F1,2
Maltese: Polysaccharide pnewmokokkali serotip 7F1,2
English: A clinical study conducted in India assessing a booster dose given at 9-12 or 15-18 months of age in 66 and 71 children, respectively, following primary vaccination at 6, 10 and 14 weeks of age, did not suggest differences between groups in terms of antibody GMCs.
Maltese: Studju kliniku li twettaq fl-Indja li evalwa doża booster li ngħatat fl-età ta' 9-12-il xahar jew 15-18il xahar f'66 u 71 wild, rispettivament, wara tilqim primarju f'età ta' 6, 10 u 14-il ġimgħa, ma ssuġġerixxiex differenza bejn il-gruppi f'termini tal-GMCs ta' antikorp.
English: Streptococcus pneumoniae and Non-Typeable Haemophilus influenzae (NTHi) are the most common causes of bacterial AOM worldwide.
Maltese: Streptococcus pneumoniae u NonTypeable Haemophilus influenzae (NTHi) huma l-aktar kawża komuni ta' AOM mill-batterja fiddinja.
English: Two efficacy studies, COMPAS and POET (Pneumococcal Otitis Media Efficacy Trial), were conducted with pneumococcal conjugate vaccines containing protein D: Synflorix and an investigational 11-valent conjugate vaccine (which in addition contained serotype 3), respectively.
Maltese: Żewġ studji dwar l-effikaċja, COMPAS u POET (Prova dwar l-Effikaċja b'Otite Medja ikkawżata minn Pnewmokokki), saru b'tilqim konjugat pnewmokokkali li kien fihom il-proteina D: Synflorix u tilqima konjugata 11-il valent taħt investigazzjoni (li kien fiha wkoll is-serotip 3), rispettivament.
English: Immune responses were compared using non-inferiority criteria in terms of antibody GMC ratio (GMC from group of subjects receiving Synflorix without 2-PE over GMC from group of subjects receiving Synflorix with 2-PE) for each of the 10 vaccine serotypes and for the cross-reactive serotype 19A.
Maltese: Ir-rispons immunitarju tqabbel bl-użu ta' kriterji ta' non-inferjorità f'termini ta' proporzjon GMC talantikorpi (GMC minn grupp ta' individwi li rċevew Synflorix mingħajr 2-PE fuq GMC minn grupp ta' individwi li rċevew Synflorix b'2-PE) għal kull wieħed mill-10 serotipi tal-vaċċin u għas-serotip kross-reattiv 19A.
English: Safety of Synflorix was assessed in 83 HIV positive (HIV+/+) infants (asymptomatic or with mild symptoms according to WHO classification), 101 HIV negative infants born from HIV positive mothers (HIV+/-) and 50 infants with sickle cell disease (SCD), receiving primary vaccination.
Maltese: Is-sigurtà ta' Synflorix ġiet evalwata fi 83 tarbija pożittiva għall-HIV (HIV+/+) (mingħajr sintomi jew b'sintomi ħfief skont il-klassifikazzjoni ta' WHO, f'101 tarbija negattivi għall-HIV li twieldu minn ommijiet pożittivi għall-HIV (HIV+/-) u f'50 tarbija bil-marda sickle-cell (SCD), li kienu qed jirċievu tilqim primarju.
English: Multidose vial 2-dose vial EU/1/09/508/009 4-dose vial EU/1/09/508/012 EU/1/09/508/013
Maltese: EU/1/09/508/009 Kunjett ta' 4 dożi EU/1/09/508/012 EU/1/09/508/013
English: (3) Culture or PCR confirmed cases for serotypes 4, 6B, 7F, 9V, 14, 18C, 19F and 23F contributed to the analysis.
Maltese: (3) Każijiet ikkonfermati mill-kultura jew mill-PCR għal serotipi 4, 6B, 7F, 9V, 14, 18C, 19F u 23F ikkontribwixxew għall-analiżi.
English: In Brazil, Synflorix was introduced into the national immunisation programme (NIP) using a 3+1 schedule in infants (2, 4, 6 months of age and a booster dose at 12 months) with a catch-up campaign in children up to 2 years of age.
Maltese: Fil-Brażil, Synflorix kien introdott fil-programm ta' immunizzazzjoni nazzjonali (NIP) permezz ta' skeda 3+1 fit-trabi (2, 4, 6 xhur ta' età u doża booster f'12-il xahar) b'kampanja ta' catch-up fi tfal li għandhom sa sentejn.
English: 1-dose and 2-dose containers Sodium chloride Water for injections
Maltese: Kontenituri ta' doża 1 u ta' 2 dożi Sodium chloride
English: CI Confidence Interval (1) In FinIP apart from serotypes 6B and 14, culture-confirmed vaccine serotype IPD cases included 7F (1 case in the Synflorix 2+1 clusters), 18C, 19F and 23F (1 case of each in the control clusters).
Maltese: Intervall ta' Kunfidenza (1) F'FinIP minbarra s-serotipi 6B u 14, il-każijiet ta' IPD mis-serotipi tal-vaċċin ikkonfermati permezz ta' kulturi kienu jinkudu 7F (każ wieħed fil-gruppi li ħadu Synflorix 2+1), 18C, 19F u
English: Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Maltese: Vaċċin konjugat (adsorbit) ta' polysaccharide pnewmokokkali
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to any of the carrier proteins.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1, jew għal xi proteini carrier.
English: • Synflorix is available in vials for 4 doses in packs of 10 or 100.
Maltese: • Synflorix jiġi f'kunjetti għal 4 dożi f'pakketti ta' 10 jew 100.
English: Before NIP
Maltese: Qabel NIP
English: For C-CAP it was 15.1% (95% CI: -15.5; 37.6) and 26.3% (95% CI: 4.4; 43.2) respectively.
Maltese: 6% (95% CI: 6.5; 32.6) u 24.2% (95% CI: 7.4; 38.0) rispettivament).
English: A clinical study conducted in Burkina Faso assessed the immunogenicity of Synflorix administered to 146 children with SCD (haemoglobin SS disease, haemoglobin SC disease or with β-thalassemia) compared to 143 age-matched children without SCD.
Maltese: Studju kliniku li twettaq fil-Burkina Faso evalwa l-immunoġeniċità ta' Synflorix li ngħata lil 146 wild b'SCD (mard ta' emoglobina
English: PHARMACEUTICAL FORM Suspension for injection (injection).
Maltese: Suspensjoni għall-injezzjoni (injezzjoni).
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Maltese: Ir-riskju potenzjali ta' apneja u l-ħtieġa ta' monitoraġġ respiratorju għal 48-72 siegħa għandhom ikunu kkunsidrati meta tingħata s-serje primarja ta' tilqim lil trabi prematuri ħafna (li twieldu wara ≤ 28 ġimgħa ta' tqala), b'mod speċjali lil dawk li kellhom storja medika ta' immaturità respiratorja.
English: Pneumococcal polysaccharide serotype 11,2
Maltese: Polysaccharide pnewmokokkali serotip 11,2
English: MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals S.A.
Maltese: GlaxoSmithKline Biologicals s.a.
English: Synflorix is always injected into a muscle.
Maltese: Synflorix jiġi njettat ġo muskolu.
English: 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.
Maltese: F'kull grupp, il-persistenza tar-rispons immuni ġiet osservata fl-età ta' 24-27 xahar, jiġifieri sa 15il xahar wara t-tilqima booster.
English: Non-inferiority was demonstrated as the upper limit of the 2-sided 95% CI of the antibody GMC ratios was below 2 for each of the 10 vaccine serotypes and for serotype 19A.
Maltese: In-non-inferjorità ntweriet bħala l-limitu ta' fuq ta' 95 % CI ta' żewġ naħat tal-proporzjonijiet GMC tal-antikorpi kienet taħt 2 għal kull wieħed mill-10 serotipi fil-vaċċin u għas-serotip 19A.
English: In a clinical study NPC was assessed in HIV positive infants (N = 83) and HIV negative infants born from HIV positive mothers (N = 101) and compared to HIV negative infants born from HIV negative mothers (N = 100).
Maltese: Fi studju kliniku, ġie evalwat l-NPC fi trabi pożittivi għall-HIV (N = 83) u fi trabi negattivi għall-HIV li twieldu minn ommijiet pożittivi għall-HIV (N = 101) u tqabblu ma' trabi negattivi għall-HIV li twieldu minn ommijiet negattivi għall-HIV (N = 100).
English: In the nested Finnish study, a significant reduction was also observed for individual serotypes 14, 23F and, in the 3 dose primary schedule, for the cross-reactive serotype 19A.
Maltese: Fl-istudju nested Finlandiż, kien osservat ukoll tnaqqis sinifikanti għas-serotipi individwali 14, 23F u, fl-iskeda primarja ta' 3 dożi, għas-serotip kross reattiv19A.
English: Anti-6B 63.1 Anti-7F 99.3 Anti-9V 99.3 Anti-14 100 Anti-18C 99.3 Anti-19F 96.1 Anti-23F 77.6
Maltese: 7 Anti-4 99.3 Anti-5 100 Anti-6B 63.1 Anti-7F 99.3 Anti-9V 99.3 Anti-14 100
English: Vaccine effectiveness or efficacy (VE) was demonstrated in preventing culture-confirmed IPD due to vaccine pneumococcal serotypes when Synflorix was given to infants in either 2+1 or 3+1 schedules in FinIP or 3+1 schedule in COMPAS (see Table 1).
Maltese: L-effikaċja jew l-effettività tal-vaċċin (VE) fil-prevenzjoni ta' IPD minn serotipi pnewmokokkali talvaċċin, ikkonfermati permezz ta' kulturi, ġiet murija meta Synflorix ingħata lit-trabi fl-iskedi 2+1 jew 3+1 f'FinIP jew fl-iskeda 3+1 f'COMPAS (ara Tabella 1).
English: Among children with SCD, 48 children <6 months of age received primary vaccination at 8, 12 and 16 weeks of age, followed by a booster dose at 9-10 months of age, 50 children aged 7-11 months and 48 aged 12-23 months started catch-up vaccination according to their age.
Maltese: Fost tfal b'SCD, 48 wild ta' età ta' <6 xhur irċivew tilqim primarju f'età ta' 8, 12 u 16-il ġimgħa, segwit minn doża booster f'età ta' 9-10 xhur, 50 wild ta' 7-11il xahar u 48 ta' 12-23 xahar bdew tilqim “catch-up” skont l-età tagħhom.
English: Pneumococcal polysaccharide serotype 51,2
Maltese: Polysaccharide pnewmokokkali serotip 51,2
English: A clinical study conducted in South Africa assessed the immunogenicity of Synflorix after 3-dose (610-14 weeks of age) or 2-dose (6-14 weeks of age) priming followed by a booster dose at 9-10 months of age.
Maltese: Studju kliniku li twettaq fl-Afrika t'Isfel evalwa l-immunoġeniċità ta' Synflorix wara pprajmjar bi 3 dożi (età ta' 6-10-14-il ġimgħa) jew ipprajmjar b'2 dożi (età ta' 6-14-il ġimgħa) segwit minn doża booster f'età ta' 9-10 xhur.
English: In a large-scale phase III, randomized, double-blind clinical trial (Clinical Otitis Media and Pneumonia Study - COMPAS) conducted in Argentina, Panama and Colombia, healthy infants aged 6 to 16 weeks received either Synflorix or hepatitis B control vaccine at 2, 4 and 6 months of age followed respectively by either Synflorix or hepatitis A control vaccine at 15 to 18 months of age.
Maltese: III (Clinical Otitis Media and Pneumonia Study - COMPAS) li saret fl-Arġentina, il-Panama u l-Kolombja, trabi b'saħħithom ta' bejn is-6 u s-16-il ġimgħa rċevew jew Synflorix jew vaċċin ta' kontroll tal-epatite B meta kellhom xahrejn, 4 u 6 xhur rispettivament segwit minn jew Synflorix jew tilqima ta' kontroll tal-epatite A meta kellhom 15 sa 18-il xahar.
English: Based on almost 3 years of surveillance following Synflorix introduction, a matched case-control study reported a significant decrease in culture or PCR confirmed IPD due to any vaccine serotype, and IPD due to individual serotypes 6B, 14 and 19A.
Maltese: Abbażi ta' 3 snin ta' sorveljanza wara l-introduzzjoni ta' Synflorix, studju ta' kontroll tal-każijiet imqabbel irrapporta tnaqqis sinifikanti fl-IPD ikkonfermata mill-kultura jew millIPD minħabba kwalunkwe serotip tal-vaċċin, u IPD minħabba s-serotipi individwali 6B, 14 u19A.
English: Needle protector
Maltese: Il-protezzjoni kontra
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
Maltese: 10 siringi mimlija għal-lest + 10 labriet 10 x 1 dożi (0.5 ml)
English: Pneumococcal polysaccharide serotype 141,2
Maltese: Polysaccharide pnewmokokkali serotip 141,2
English: 10 doses (0.5 ml)
Maltese: 2 dożi (0.5 ml/doża)
English: In clinical studies the immunogenicity of Synflorix was evaluated after a 2-dose primary vaccination series (470 subjects) according to different schedules (including 6-14 weeks, 2-4 or 3-5 months of age) and after a third (booster) dose (470 subjects) given at least 6 months after the last primary dose and from the age of 9 months onwards.
Maltese: Fi studji kliniċi, l-immunoġeniċità ta' Synflorix ġiet evalwata wara serje ta' tilqim primarju ta' 2 dożi (470 individwu) skont skedi differenti (inkluż età ta' 6-14-il ġimgħa, 2-4 jew 3-5 xhur) u wara t-tielet doża (booster) (470 individwu) li ngħatat tal-inqas 6 xhur wara l-aħħar doża primarja u mill-età ta' 9 xhur 'il quddiem.
English: The clinical data suggest that paracetamol might reduce the immune response to Synflorix.
Maltese: Id-dejta klinika tissuġġerixxi li paracetamol jista' jnaqqas ir-rispons immuni għal Synflorix.
English: IPD Invasive Pneumococcal Disease
Maltese: IPD Mard Pnewmokokkali
English: In the study conducted in South Africa, the booster dose given at 9-10 months of age induced marked increases in antibody GMCs and OPA GMTs for each vaccine serotype and serotype 19A in both 2dose and 3-dose priming groups indicative of immunological priming.
Maltese: Fi studju li twettaq fl-Afrika t'Isfel, id-doża booster li ngħatat fl-età ta' 9-10 xhur induċiet żidiet ċari fil-GMCs ta' antikorpi u fil-GMTs ta' OPA għal kull serotip tal-vaċċin u għas-serotip 19A fiż-żewġ gruppi ta' pprajmjar b'2 dożi u ta' 3 dożi indikattivi għal ipprajmjar immunoloġiku.
English: Table 8: Percentage of 3-dose primed subjects with antibody concentrations ≥ 0.20 µg/ml one month post-primary and one month post-booster Antibody
Maltese: Tabella 8: Perċentwal ta' individwi mlaqqma bi tliet dożi b'konċentrazzjonijiet ta' antikorpi ta' ≥ 0.20 µg/ml xahar wara t-tilqim primarju u xahar wara t-tilqima booster