qanastek/EMEA-V3 huggingface dataset:
What benefit has Prevenar shown during the studies?
X' benefiċċji ta 'Prevenar intwerew f' dawn l- istudji?
Prevenar was effective in preventing S. pneumoniae invasive disease.
Prevenar kien effikaċi fil- prevenzjoni tal- marda invażiva ta 'S. pneumoniae.
During the main study, 49 cases of infection due to the serotypes 4, 6B, 9V, 14, 18C, 19F and 23F of S. pneumoniae were seen among the infants who received the control vaccine, compared with three cases among the infants vaccinated with Prevenar.
Waqt l- istudju ewlieni, dehru 49 każ ta 'infezzjoni mis- serotipi 4, 6B, 9V, 14, 18C, 19F u 23F ta' S. pneumoniae fi tfal żgħar li kienu qed jingħataw il- vaċċin tal- kontroll, imqabbla ma 'tliet każijiet fost tfal żgħar imlaqqma bi Prevenar.
The additional studies showed that Prevenar was safe and effective in children up to the age of five years.
L- istudji addizzjonali wrew li Prenavar kien sigur u effikaċi fit- tfal sa l- età ta 'ħames snin.
In infants, the two-dose immunisation schedule led to the development of antibodies against S. pneumoniae, but to a lower level than the three-dose schedule.
Fit- tfal żgħar, il- programm ta 'immunizzazzjoni b' żewġ dożi wassal għall- iżvilupp ta' antikorpi kontra S. pneumoniae, iżda fuq livelli aktar baxxi meta mqabbla mal- programm bi tliet dożi.
However, the CHMP concluded that this is unlikely to lead to a difference in the rate of protection against infection with S. pneumoniae following a booster injection, when Prevenar is used as part of a routine immunisation programme in which most infants are vaccinated.
Madankollu, is - CHMP ikkonkluda li aktarx mhux se jwassal għal differenza fil- livell ta 'protezzjoni kontra infezzjoni bi S. pneumoniae wara injezzjoni booster, meta Prevenar jintuża bħala parti mill- programm ta' immunizzazzjoni ta 'rutina, li jipprevedi t- tilqim fil- maġġoranza tat- tfal żgħar.
What is the risk associated with Prevenar?
X' inhu r- riskju assoċjat ma 'Prevenar?
The most common side effects with Prevenar (seen in more than 1 patient in 10) are vomiting, diarrhoea, loss of appetite, reactions at the site of the injection (redness, hardening, swelling or pain), fever, irritability, drowsiness and restless sleep.
L- iktar effetti sekondarji komuni ta 'Prevenar (li dehru f' aktar minn pazjent wieħed minn kull għaxra) huma r- remettar, dijarrea, nuqqas ta' aptit, reazzjonijiet fil- punt ta 'l- injezzjoni (ħmura, ebusija, nefħa jew uġigħ), deni, irritabilità, ngħas kbir u rqad mingħajr mistrieħ.
For the full list of all side effects reported with Prevenar, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrapportati bi Prevenar, ara l- Fuljett ta' Tagħrif.
Prevenar should not be used in children who may be hypersensitive (allergic) to the Streptococcus vaccine, to any of the other ingredients or to the diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).
Prevenar ma għandux jingħata lil tfal li jistgħu jkunu ipersensittivi (allerġiċi) għall- vaċċin ta 'Streptococcus jew għal kwalunkwe sustanza oħra jew għat- tossojde difteriku (toxoid diphtheria, tossina li ddgħajfet mill- batterju li tikkawża d- difterite).
As for all vaccines, if Prevenar is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Bħal ma jiġri fil- vaċċini kollha, f' każ li Prevenar jingħata lil trabi li twieldu prematuri ħafna, hemm ir- riskju li dawn taqbadhom apnea (pawża qasira meta jieħdu n- nifs).
Their breathing should be monitored for up to three days after vaccination.
Għalhekk, in- nifs tagħhom għandu jiġi kkontrollat sa tlett ijiem wara t - tilqim.
Why has Prevenar been approved?
Għaliex ġie approvat Prevenar?
The Committee for Medicinal Products for Human Use (CHMP) decided that Prevenar’ s benefits are greater than its risks for active immunisation against disease caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li Prevenar għandu aktar benefiċċji milli riskji fit- tilqim attiv kontra l- marda kkawżata minn S. pneumoniae serotipi 4, 6B, 9V, 14, 18C, 19F u 23F (inkluż sepsi, meninġite, pulmonite, batterjemija u otite medja akuta fit- tfal ta 'bejn xahrejn u ħames snin.
The Committee recommended that Prevenar be given marketing authorisation.
Il- Kumitat irrakkomanda li Prevenar jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Prevenar:
Tagħrif ieħor dwar Prevenar:
The European Commission granted a marketing authorisation valid throughout the European Union for Prevenar to Wyeth Lederle Vaccines S. A. on 2 February 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Prevenar valida fl- Unjoni Ewropea kollha lil Wyeth Lederle Vaccines S. A. fit- 2 ta 'Frar ta' l- 2001.
The marketing authorisation was renewed on 2 February 2006.
L- awtorizzazzjoni għat - tqegħid fis- suq iġġeddet fit- 2 ta 'Frar 2006.
2/ 3 The full EPAR for Prevenar is available here.
2/ 3 L- EPAR sħiħ għal Prevenar huwa disponibbli minn hawn.
Prevenar – Pharmaceutical Form(s) and Strength(s)
Prevenar – Għamla( iet) Farmaċewtika( ċi) u Qawwa( iet) Numru ta ’ l- EU >
Intramuscular use
Użu għal ġol- muskoli
1 vial with 1 syringe and 2 needles
1 kunjett b’ 1 siringa u b’ 2 labriet
1 pre-filled syringe with separate needle
1 siringa mimlija għal - lest b’ labra separata
10 pre-filled syringes with separate needles
10 siringi mimlijin għal- lest b’ labar separati
5 x 10 pre-filled syringes
5 x 10 siringi mimlijin għal- lest
* A monodose preparation of 0.5 ml contains:
* Preparazzjoni ta ’ doża waħda ta ’ 0. 5 ml fiha:
Streptococcus pneumoniae saccharide suspension of:
Suspensjoni ta ’ streptococcus pneumoniae saccharide ta ’:
Serotype 4 Serotype 9V Serotype 14 Serotype 18C Serotype 19F Serotype 23F Serotype 6B
Serotip 4 Serotip 9V 2 Serotip 14 2
2 µg 2 µg 2 µg 2 µg 2 µg 2 µg
2 μg μg μg
Conjugated to CRM197 carrier protein
Serotip 18C 2 μg Serotip 19F 2 μg Serotip 23F 2 μg Serotip 6B 4 μg Konjugat għal CRM197 proteina carrier ~ 20 μg
Prevenar suspension for injection Pneumococcal saccharide conjugated vaccine, adsorbed
Prevenar suspensjoni għall- injezzjoni Tilqima konjugata saccharide pnewmokokkali, adsorbita
Each 0.5 ml dose contains:
Kull doża ta ’ 0. 5 ml fiha:
Pneumococcal polysaccharide serotype 4* Pneumococcal polysaccharide serotype 6B* Pneumococcal polysaccharide serotype 9V* Pneumococcal polysaccharide serotype 14* Pneumococcal oligosaccharide serotype 18C* Pneumococcal polysaccharide serotype 19F* Pneumococcal polysaccharide serotype 23F*
Serotip polysaccharide pnewmokokkali 4 * Serotip polysaccharide pnewmokokkali 6B * Serotip polysaccharide pnewmokokkali 9V * Serotip polysaccharide pnewmokokkali 14F * Serotip oligosaccharide pnewmokokkali 18C * Serotip polysaccharide pnewmokokkali 19F * Serotip polysaccharide pnewmokokkali 23F *
* Conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg)
* Konjugat għall- proteina carrier CRM197 u adsorbit fuq aluminium phosphate (0. 5 mg)
The vaccine is a homogeneous white suspension.
It- tilqima hi suspensjoni bajda omoġenja.
Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from 2 months up to 5 years of age (see sections 4.2, 4.4 and 5.1).
Tilqima attiva kontra mard ikkawżat minn Streptococcus pneumoniae serotipi 4, 6B, 9V, 14, 18C, 19F u 23F (li jinkludi sepsis, meninġite, pnewmonja, batteremija u infjammazzjoni akuta fil- parti tan- nofs tal- widna) fi trabi u fi tfal minn xahrejn sa 5 snin (ara sezzjonijiet 4. 2, 4. 4 u 5. 1).
For the number of doses to be administered in the different age groups, see section 4.2.
Għan- numru ta ’ dożi li jridu jingħataw fil- gruppi differenti ta ’ età, ara sezzjoni 4. 2.
The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas (see sections 4.4, 4.8 and 5.1).
L- użu ta ’ Prevenar għandu jkun stabbilit fuq il- bażi ta ’ rakkomandazzjonijiet uffiċjali, li jikkunsidraw l- impatt ta ’ mard invażiv fi gruppi different ta ’ età, kif ukoll il- varjabilità tal- epidemjoloġija tas- serotip f’ żoni ġeografiċi differenti (ara sezzjonijiet 4. 4, 4. 8 u 5. 1).
The vaccine should be given by intramuscular injection.
It- tilqima għandha tingħata permezz ta ’ injezzjoni ġol- muskoli.
The preferred sites are anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in young children.
Is- siti ppreferuti huma n- naħa anterolaterali tal- koxxa (muskolu vastus lateralis) fit- trabi, jew il- muskolu deltojd tan- naħa ta ’ fuq tad- driegħ fi tfal żgħar.
Immunisation schedules:
Skedi tal- immunizzazzjoni:
The immunisation schedules for Prevenar should be based on official recommendations.
L- iskedi tal- immunizzazzjoni għal Prevenar għandhom ikunu bbażati fuq rakkomandazzjonijiet uffiċjali.
2 Infants aged 2 - 6 months:
Trabi ta ’ bejn 2 - 6 xhur:
The primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
L- ewwel doża normalment tingħata meta t- tarbija jkollha xahrejn, b’ intervall ta ’ mill- anqas xahar bejn id- dożi.
A fourth dose is recommended in the second year of life.
Ir- raba ’ doża hi rakkomandata fit- tieni sena tal- ħajja.
Alternatively, when Prevenar is given as part of a routine infant immunisation programme, a two-dose schedule may be considered.
2 Alternattivament, meta Prevenar jingħata bħala parti minn programm ta ’ rutina ta ’ immunizzazzjoni lit- trabi, tista ’ tkun ikkunsidrata skeda b’ żewġ dożi.
The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11-15 months of age (see section 5.1)
L- ewwel doża tista ’ tingħata mill- età ta ’ xahrejn, bit- tieni doża li tingħata mill- inqas xahrejn wara, u t- tielet doża (booster) li tingħata fl- età ta ’ 11- 15- il xahar (ara sezzjoni 5. 1)
Previously unvaccinated older infants and children:
Trabi akbar u tfal li ma ngħatawx tilqima qabel:
Infants aged 7 - 11 months: two doses, each of 0.5 ml, with an interval of at least 1 month between doses.
Trabi ta ’ bejn 7 - 11- il xahar: żewġ dożi, kull waħda ta ’ 0. 5 ml, b’ intervall ta ’ mill- anqas xahar bejn id- dożi.
A third dose is recommended in the second year of life.
It- tielet doża hi rakkomandata fit- tieni sena tal- ħajja.
Children aged 12 - 23 months: two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
Tfal li għandhom bejn 12 - 23 xahar: żewġ dożi, kull waħda ta ’ 0. 5 ml, b’ intervall ta ’ mill- anqas xahrejn bejn id- dożi.
Children aged 24 months – 5 years: one single dose.
Tfal li għandhom bejn 24 xahar – 5 snin: doża waħda.
The need for a booster dose after these immunisation schedules has not been established.
Il- ħtieġa ta ’ doża booster wara dawn l- iskedi ta ’ immunizzazzjoni ma kinitx stabbilita.
Hypersensitivity to the active substances or to any of the excipients, or to diphtheria toxoid.
Sensittività eċċessiva għas- sustanzi attivi jew għal xi sustanzi mhux attivi, jew għat- toxoid tad - difterite.
As with other vaccines, the administration of Prevenar should be postponed in subjects suffering from acute moderate or severe febrile illness.
Bħal fil- każ ta ’ tilqim ieħor, l- għoti ta ’ Prevenar għandu jkun pospost f’ persuni li jbatu minn mard b’ deni akut jew sever.
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.
Bħat- tilqim kollu li jista ’ jiġi injettat, il- kura u s- superviżjoni medika adattata għandhom dejjem ikunu disponibbli fil- pront f’ każ ta ’ avveniment anafilattiku rari wara l- għoti tat- tilqima.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h 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.
Ir- riskju potenzjali ta ’ apnea u l- ħtieġa għal monitoraġġ respiratorju għal 48- 72 siegħa għandhom ikunu kkunsidrati meta tagħti s- serje tal- immunizzazzjoni primarja lil trabi prematuri ħafna (li twieldu wara ≤ 28 ġimgħa ta ’ tqala) u partikularment lil dawk li kellhom storja medika ta ’ immaturità respiratorja.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Minħabba li l- benefiċċju tat- tilqima hu għoli f’ dan il- grupp tat- trabi, it- tilqima m’ għandhiex tinżamm jew tkun ittardjata.
Prevenar will not protect against other Streptococcus pneumoniae serotypes than those included in the vaccine nor other micro-organisms that cause invasive disease or otitis media.
Prevenar mhux ser jipproteġi kontra serotipi oħrajn ta ’ Streptococcus pneumoniae ħlief dawk inklużi fit- tilqima, jew kontra mikro- organiżmi oħrajn li jikkawżaw mard invażiv jew infjammazzjoni fil- parti tan- nofs tal- widna.
This vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration.
Din it- tilqima m’ għandhiex tingħata lil trabi jew lil tfal li għandhom it- tromboċitopenja jew kwalunkwe disturb tal- koagulazzjoni li minħabba fih l- injezzjoni ġol- muskoli tkun kontraindikata, ħlief jekk il- benefiċċju potenzjali jiżboq b’ mod ċar ir- riskju tal- għoti.
Although some antibody response to diphtheria toxoid may occur, immunisation with this vaccine does not substitute for routine diphtheria immunisation.
Għalkemm xi rispons tal- antikorpi għat- toxoid tad- difterite jista ’ jseħħ, l- immunizzazzjoni b’ din it - tilqima ma tissostwixxix l- immunizzazzjoni ta ’ rutina kontra d- difterite
For children from 2 years through 5 years of age, a single dose immunisation schedule was used.
Għal tfal minn sentejn sa 5 snin, intużat skeda ta ’ immunizzazzjoni li kienet tikkonsisti f’ doża waħda.
A higher rate of local reactions has been observed in children older than 24 months of age compared with infants (see section 4.8).
Rata ogħla ta ’ reazzjonijiet lokali kienet osservata fi tfal li kellhom iktar minn 24 xahar, meta mqabbla mat- trabi (ara sezzjoni 4. 8).
Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunisation.
Tfal b’ indeboliment fir- rispons immuni, kemm jekk dan iseħħ minħabba l- użu ta ’ terapija immunosoppressiva, difett ġenetiku, infezzjoni bl- HIV, jew kawżi oħrajn, jista ’ jkollhom tnaqqis fir - rispons tal- antikorpi għall- immunizzazzjoni attiva.
3 Limited data have demonstrated that Prevenar (three dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups (see section 5.1).
Dejta limitata wriet li Prevenar (serje primarja bi tliet dożi) jikkaġuna rispons immuni aċċettabbli fi trabi li għandhom il- marda taċ- ċelluli sickle, bi profil tas- sigurtà simili għal dak osservat fi gruppi li mhux qegħdin f’ riskju għoli (ara sezzjoni 5. 1).
Safety and immunogenicity data are not yet available for children in other specific high-risk groups for invasive pneumococcal disease (e. g. children with another congenital or acquired splenic dysfunction, HIV-infected, malignancy, nephrotic syndrome).
3 pnewmokokkali invażiv (eż. tfal b’ disfunzjoni konġenitali oħra jew b’ disfunzjoni miksuba tal- milsa, li huma infettati bl- HIV, li għandhom malinn, u li għandhom sindrome nefrotiku).
Vaccination in high-risk groups should be considered on an individual basis.
It- tilqima fi gruppi li qegħdin f’ riskju għoli għandha tkun ikkunsidrata fuq bażi individwali.
Children below 2 years old should receive the appropriate-for-age Prevenar vaccination series (see section 4.2).
Tfal ta ’ taħt is- sentejn għandhom jirċievu s- serje ta ’ tilqim ta ’ Prevenar li hi adattata għall- età tagħhom (ara sezzjoni 4. 2).
The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children ≥ 24 months of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness or who are immunocompromised) placing them at higher risk for invasive disease due to Streptococcus pneumoniae.
L- użu ta ’ tilqima konjugata pnewmokokkali ma tissostitwixxix l- użu ta ’ tilqim tal - polysaccharide pnewmokokkali li fih 23 valent fit- tfal ≥ ta ’ 24 xahar b’ kundizzjonijiet (bħal marda taċ- ċelluli sickle, asplenja, infezzjoni bl- HIV, mard kroniku jew li huma immunokompromessi) li jpoġġuhom f’ riskju ogħla għal mard invażiv minħabba Streptococcus pneumoniae.
Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Prevenar should receive 23-valent pneumococcal polysaccharide vaccine.
Fejn ikun rakkomandat, it- tfal f’ riskju li għandhom ≥ 24 xahar u li jkunu diġà tlaqqmu bi Prevenar, għandhom jirċievu tilqima tal- polysaccharide pnewmokokkali li fiha 23 valent.
The interval between the pneumococcal conjugate vaccine (Prevenar) and the 23- valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
L- intervall bejn it- tilqima tal - konjugat pnewmokokkali (Prevenar) u t- tilqima tal- polysaccharide pnewmokokkali li fiha 23 valent, m’ għandux ikun ta ’ inqas minn 8 ġimgħat.
There are no data available to indicate whether the administration of 23-valent pneumococcal polysaccharide vaccine to unprimed children or to children primed with Prevenar might result in hyporesponsiveness to further doses of Prevenar.
M’ hemm l- ebda informazzjoni disponibbli li tindika jekk l- għoti ta ’ tilqima tal- polysaccharide pnewmokokkali li fiha 23 valent lil tfal li ma jkunux tlaqqmu, jew lil tfal li jkunu diġà tlaqqmu bi Prevenar, jistax jirriżulta f’ rispons eċċessiv għal dożi addizzjonali ta ’ Prevenar.
When Prevenar is co-administered with hexavalent vaccines (DTaP/ Hib(PRP-T)/ IPV/ HepB), the physician should be aware that data from clinical studies indicate that the rate of febrile reactions was higher compared to that occurring following the administration of hexavalent vaccines alone.
Meta Prevenar jingħata flimkien ma ’ tilqim eżavalenti (DTaP/ Hib( PRP- T) / IPV/ HepB), it- tabib għandu jkun konxju li dejta minn studji kliniċi tindika li r- rata ta ’ reazzjonijiet bid- deni kienet ogħla meta mqabbla ma ’ dik li sseħħ wara l- għoti ta ’ tilqim eżavalenti waħdu.
These reactions were mostly moderate (less than or equal to 39 °C) and transient (see section 4.8).
Dawn ir- reazzjonijiet kienu fil - biċċa l- kbira tagħhom moderati (inqas minn jew 39°C) u kienu temporanji (ara sezzjoni 4. 8).
Antipyretic treatment should be initiated according to local treatment guidelines.
Il- kura kontra d- deni għandha tinbeda skont il- linji gwida lokali tal- kura.
Prophylactic antipyretic medication is recommended:
Mediċina profilattika kontra d- deni hi rakkomandata:
- for all children receiving Prevenar simultaneously with vaccines containing whole cell pertussis
- għat- tfal kollha li jkunu qed jirċievu Prevenar fl- istess ħin ma ’ tilqim li jkun fih whole cell
because of higher rate of febrile reactions (see section 4.8).
pertussis minħabba rata ogħla ta ’ reazzjonijiet bid- deni (ara sezzjoni 4. 8).
- for children with seizure disorders or with a prior history of febrile seizures.
- għat- tfal li jkollhom il- puplesiji, jew li jkollhom passat mediku ta ’ puplesiji kkawżati mid- deni.
Do not administer Prevenar intravenously.
Tagħtix Prevenar minn ġol- vina.
As with any vaccine, Prevenar may not protect all individuals receiving the vaccine from pneumococcal disease.
Bħal ma jiġri bi kwalunkwe tilqima, Prevenar jista ’ ma jipproteġix l- individwi kollha li jkunu qed jirċievu t- tilqima kontra l- marda pnewmokokkali.
Additionally, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease.
Flimkien ma ’ dan, għas- serotipi tat- tilqima, il - protezzjoni kontra l- infjammazzjoni fil- parti tan- nofs tal- widna hi mistennija li tkun iktar baxxa b’ mod sostanzjali milli mill- protezzjoni kontra l- mard invażiv.
As otitis media is caused by many organisms other than pneumococcal serotypes represented in the vaccine, protection against all otitis media is expected to be low (see section 5.1).
Minħabba li l- infjammazzjoni fil- parti tan - nofs tal- widna hi kkawżata minn ħafna organiżmi li mhumiex serotipi pnewmokokkali rappreżentati fit- tilqima, il- protezzjoni kontra l- infjammazzjonijiet kollha fil- parti tan- nofs tal- widna hi mistennija li tkun baxxa (ara sezzjoni 5. 1).
Prevenar can be administered simultaneously with other paediatric vaccines in accordance with the recommended immunisation schedules.
Prevenar jista ’ jingħata fl- istess ħin ma ’ tilqim pedjatriku ieħor skont l- iskedi rakkomandati tal - immunizzazzjoni.
Different injectable vaccines should always be given at different injection sites.
Tilqim differenti li jista ’ jiġi injettat għandu dejjem jingħata f’ siti differenti tal - injezzjoni.
The immune response to routine paediatric vaccines co-administered with Prevenar at different injection sites was assessed in 7 controlled clinical studies.
Ir- rispons immuni għat- tilqim pedjatriku ta ’ rutina mogħti flimkien ma ’ Prevenar f’ siti differenti tal - injezzjoni, kien evalwat f’ 7 studji kliniċi kkontrollati.
The antibody response to Hib tetanus protein conjugate (PRP-T), tetanus and Hepatitis B (HepB) vaccines was similar to controls.
Ir- rispons tal- antikorpi għat- tilqim bil- konjugat tal- proteina tat- tetnu Hib (PRP- T), tetnu u Epatite B (HepB) kien simili għall- kontrolli.
For CRM-based Hib conjugate vaccine, enhancement of antibody responses to Hib and diphtheria in the infant series was observed.
Għat- tilqim konjugat Hib ibbażat fuq is- CRM, kien osservat titjib fir- risponsi tal- antikorpi għall- Hib u d- difterite fis- serje ta ’ tilqim li tingħata lit- trabi.
At the booster, some suppression of Hib antibody level was observed but all children had protective levels.
Meta ngħata l- booster, xi trażżin tal- livell tal- antikorpi Hib kien osservat, iżda t- tfal kollha kellhom livelli protettivi.
Inconsistent reduction in response to pertussis antigens as well as to inactivated polio vaccine (IPV) were observed.
Tnaqqis inkonsistenti fir- rispons għall- antiġeni tal- pertussis, kif ukoll għat- tilqima tal- polio inattivata (inactivated polio vaccine - IPV) kien osservat.
The clinical relevance of these interactions is unknown.
Ir- rilevanza klinika ta ’ dawn l- interazzjonijiet mhijiex magħrufa.
Limited results from open label studies showed an acceptable response to MMR and varicella.
Riżultati limitati minn studji open label urew rispons aċċettabbli għall- MMR u l- ġidri r- riħ.
4 Data on concomitant administration of Prevenar with Infanrix hexa (DTaP/ Hib(PRP-T)/ IPV/ HepB vaccine) have shown no clinically relevant interference in the antibody response to each of the individual antigens when given as a 3 dose primary vaccination.
4 Dejta dwar l- għoti fl- istess ħin ta ’ Prevenar ma ’ Infanrix hexa (tilqima DTaP/ Hib( PRP- T) / IPV/ HepB) ma wriet l- ebda interferenza klinikament rilevanti fir- rispons tal- antikorpi għal kull wieħed mill - antiġeni individwali, meta mogħtija bħala tilqima primarja ta ’ 3 dożi.
Sufficient data regarding interference on the concomitant administration of other hexavalent vaccines with Prevenar are currently not available.
Dejta suffiċjenti dwar l- interferenza meta jsir l- għoti fl- istess ħin ta ’ tilqim ieħor eżavalenti flimkien ma ’ Prevenar, bħalissa mhijiex disponibbli.
In a clinical trial that compared separate with concomitant administrations of Prevenar (three doses at 2, 3.5, 6 months and a booster dose at approximately 12 months) and Meningitec (meningococcal C conjugate vaccine; two doses at 2 and 6 months and a booster dose at approximately 12 months) there was no evidence of immune interference between the two conjugate vaccines after the primary series or after the booster doses.
Fi prova klinika li qabblet l- għoti separat mal- għoti fl- istess ħin ta ’ Prevenar (tliet dożi wara 2, 3. 5, 6 xhur u doża booster wara madwar 12- il xahar) u Meningitec (tilqima konjugata Ċ meningokokkali; żewġ dożi wara xahrejn u 6 xhur u doża booster wara madwar 12- il xahar), ma kien hemm l- ebda evidenza ta ’ interferenza immuni bejn iż- żewġ tilqimiet konjugati wara s- serje primarja serje jew wara d- dożi booster.
Prevenar is not intended for use in adults.
Prevenar mhuwiex intenzjonat għall- użu fl- adulti.
Information on the safety of the vaccine when used during pregnancy and lactation is not available.
Dejta dwar is- sigurtà tat- tilqima meta tintuża matul it- tqala u treddigħ mhijiex disponibbli.
The safety of the vaccine was assessed in different controlled clinical studies in which more than 18,000 healthy infants (6 weeks to 18 months) were included.
Is- sigurtà tat- tilqima kienet evalwata fi studji kliniċi kkontrollati differenti, li fihom iktar minn 18, 000 tarbija b’ saħħithom (età ta ’ minn 6 ġimgħat sa 18- il xahar) kienu inklużi.
The majority of the safety experience comes from the efficacy trial in which 17,066 infants received 55,352 doses of Prevenar.
Il- maġġoranza tal- esperjenza dwar is- sigurtà tiġi mill- prova dwar l- effikaċja li fiha 17, 066 tarbija rċivew 55, 352 doża ta ’ Prevenar.
Also safety in previously unvaccinated older children has been assessed.
Flimkien ma ’ dan, is- sigurtà fi tfal akbar li ma kinux imlaqqma kienet evalwata.
In all studies, Prevenar was administered concurrently with the recommended childhood vaccines.
Fl- istudji kollha, Prevenar ingħata fl- istess ħin mat- tilqim rakkomandat li jingħata fi żmien it- tfulija.
Amongst the most commonly reported adverse reactions were injection site reactions and fever.
Fost l- iktar reazzjonijiet avversi rrappurtati b’ mod komuni, kien hemm reazzjonijiet fis- sit tal - injezzjoni u deni.
No consistent increased local or systemic reactions within repeated doses were seen throughout the primary series or with the booster dose, the exceptions being a higher rate of transient tenderness (36.5%) and tenderness that interfered with limb movement (18.5%) were seen with the booster dose.
Ma kienet osservata l- ebda żieda konsistenti fir- reazzjonijiet lokali jew sistemiċi meta ngħataw dożi ripetuti matul is- serje primarja jew bid- doża booster, bl- eċċezzjonijiet ikunu rata ogħla ta ’ sensittività temporanja (36. 5%) u sensittività li interferixxiet mal- moviment tar- riġlejn jew tad- dirgħajn (18. 5%) li kienu osservati bid- doża booster.
In older children receiving a single dose of vaccine, a higher rate of local reactions has been observed than that previously described in infancy.
Fi tfal akbar li kienu qed jirċievu doża waħda tat- tilqima, rata ogħla ta ’ reazzjonijiet lokali kienu osservati iktar minn dak li kien deskritt qabel fi żmien it- tfulija.
These reactions were primarily transient in nature.
Dawn ir- reazzjonijiet kienu primarjament temporanji fin- natura tagħhom.
Redness was reported in 40.0% of children, and induration was reported in 32.2% of subjects.
Fi studju li sar wara li nħarġet il- liċenzja għal dan il - prodott, li kien jinvolvi 115 tifel u tifla li kellhom bejn sentejn u 5 snin, is- sensittività kienet irrappurtata f’ sa 39. 1% tat- tfal; fi 15. 7% tat- tfal, is- sensittività interferixxiet mal- moviment tar- riġlejn jew tad- dirgħajn Il- ħmura kienet irrappurtata f’ 40. 0% tat- tfal, u l- ebusija kienet irrappurtata fi 32. 2% tat- tfal.
Redness or induration > 2cm in diameter was reported in 22.6% and 13.9% of children respectively.
Il- ħmura jew l- ebusija ta ’ > 2 ċm fid- dijametru kienet irrappurtata fi 22. 6% u fi 13. 9% tat- tfal rispettivament.
When Prevenar is co-administered with hexavalent vaccines (DTaP/ Hib(PRP-T)/ IPV/ HepB), fever ≥ 38 °C per dose was reported in 28.3% to 48.3% of infants in the group receiving Prevenar and the hexavalent vaccine at the same time as compared to 15.6% to 23.4% in the group receiving the hexavalent vaccine alone.
Meta Prevenar jingħata flimkien ma ’ tilqim eżavalenti (DTaP/ Hib( PRP- T) / IPV/ HepB), deni b’ temperatura ta ’ ≥ 38°C kull doża kien irrappurtat fi 28. 3% sa 48. 3% tat- trabi fil- grupp li kien qed jirċievi Prevenar u t- tilqima eżavalenti fl- istess ħin meta mqabbel ma ’ 15. 6% sa 23. 4% fil- grupp li kien qed jirċievi t- tilqima eżavalenti waħidha.
Fever of greater than 39.5 °C per dose was observed in 0.6 to 2.8% of infants receiving Prevenar and hexavalent vaccines (see section 4.4).
Deni b’ temperatura ta ’ iktar minn 39. 5°C kull doża kien osservat f’ 0. 6 sa 2. 8% tat- trabi li kienu qed jirċievu Prevenar u tilqim eżavalenti (ara sezzjoni 4. 4).
Reactogenicity was higher in children receiving whole cell pertussis vaccines concurrently.
Ir- reazzjoġeneċità kienet ogħla fi tfal li kienu qed jirċievu tilqim whole cell pertussis fl- istess ħin.
In a study, including 1,662 children, fever of ≥ 38 °C was reported in 41.2% of children who received Prevenar simultaneously with DTP as compared to 27.9% in the control group.
Deni
Fever of > 39 °C was reported in 3.3% of children compared to 1.2% in the control group.
5 b’ temperatura ta ’ > 39°C kien irrappurtat fi 3. 3% tat- tfal meta mqabbel ma ’ 1. 2% fil- grupp tal - kontroll.
5 Undesirable effects reported in clinical trials or from the post-marketing experience are listed in the following table per body system and per frequency and this is for all age groups.
L- effetti mhux mixtieqa rrappurtati fil- provi kliniċi jew mill- esperjenza ta ’ wara l- bejgħ tal- prodott huma elenkati fit- tabella li ġejja skont is- sistema tal- ġisem u skont il- frekwenza, u dan japplika għall - gruppi kollha tal- età.
The frequency is defined as follows: very common: ≥ 1/ 10, common: ≥ 1/ 100 and < 1/ 10, uncommon: ≥ 1/ 1,000 and < 1/ 100, rare: ≥ 1/ 10,000 and < 1/ 1,000, very rare: ≤ 1/ 10,000.
Il- frekwenza hi mfissra kif ġej: komuni ħafna: ≥ 1/ 10, komuni: ≥ 1/ 100 u < 1/ 10, mhux komuni: ≥ 1/ 1, 000 u < 1/ 100, rari: ≥ 1/ 10, 000 u < 1/ 1, 000, rari ħafna: ≤ 1/ 10, 000.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skont is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Lymphadenopathy localised to the region of the injection site
Limfadenopatija lokalizzata fiż- żona tas- sit tal- injezzjoni
Hypersensitivity reactions such as anaphylactic/ anaphylactoid reactions including shock, angioneurotic oedema, bronchospasm, dyspnoea, face oedema.
Reazzjonijiet ta ’ sensittività eċċessiva bħal reazzjonijiet anafilattiċi/ anafillattojdi li jinkludu xokk, edema anġjonewrotika, bronkospażmu, qtugħ ta ’ nifs, edema tal- wiċċ.
Seizures, including febrile seizures.
Puplesiji, li jinkludu puplesiji kkawżati mid- deni.
Vomiting, diarrhoea, decreased appetite.
Rimettar, dijarea, nuqqas t’ aptit.
Rash/ urticaria.
Raxx/ urtikarja.
Very common:
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata:
Injection site reactions (e. g. erythema, induration/ swelling, pain/ tenderness); fever ≥ 38 °C, irritability, crying, drowsiness, restless sleep.
Reazzjonijiet fis- sit tal- injezzjoni (eż. eritema, ebusija/ nefħa, Komuni ħafna: uġigħ/ sensittività); deni ≥ 38°C, irritabilità, biki, ngħas, irqad bla kwiet.
Injection site swelling/ induration and erythema > 2.4 cm, tenderness interfering with movement, fever > 39 °C.
Nefħa/ ebusija fis- sit tal- injezzjoni u eritema > 2. 4 ċm, sensittività li tinterferixxi mal- moviment, deni > 39°C.
Hypotonic hyporesponsive episode, injection site hypersensitivity reactions (eg., dermatitis, pruritus, urticaria).
Episodju iporisponsiv ipotoniku, reazzjonijiet ta ’ sensittività eċċessiva fis- sit tal- injezzjoni (eż., dermatite, ħakk, urtikarja).
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4).
Apnea fi trabi prematuri ħafna (≤ 28 ġimgħa ta ’ tqala) (ara sezzjoni 4. 4).
There have been reports of overdose with Prevenar, including cases of administration of a higher than recommended dose and cases of subsequent doses administered closer than recommended to the previous dose.
Kien hemm rapporti ta ’ doża eċċessiva bi Prevenar, li jinkludu każijiet ta ’ għoti ta ’ doża li kienet ogħla minn dik rakkomandata, u każijiet ta ’ dożi sussegwenti li ngħataw iktar kmieni miż- żmien rakkomandat (i. e. qrib wisq tad- doża ta ’ qabel).
No undesirable effects were reported in the majority of individuals.
L- ebda effetti mhux mixtieqa ma kienu rrappurtati fil - maġġoranza tal- individwi.
In general, adverse events reported with overdose have also been reported with recommended single doses of Prevenar.
B’ mod ġenerali, l- avvenimenti avversi rrappurtati b’ doża eċċessiva kienu wkoll irrappurtati b’ dożi waħdanin irrakkomandati ta ’ Prevenar.
Pharmacotherapeutic group: pneumococcal vaccines, ATC code:
Kategorija farmakoterapewtika: tilqim pnewmokokkali, Kodiċi ATC:
Prevenar has also been shown to elicit functional
Żidiet sinifikanti fl- antikorp (imkejla permezz ta ’ ELISA) kienu osservati għas- serotipi tat- tilqim kollu wara serje primarja bi tliet dożi ta ’ Prevenar fit- trabi u wara dożi booster, għalkemm il - konċentrazzjonijiet medji ġeometriċi varjaw bejn is- 7 serotipi.
6 antibodies (measured by opsonophagocytosis) to all vaccine serotypes following the primary series.
Intwera wkoll li Prevenar jikkaġuna antikorpi funzjonali (kif imkejla permezz ta ’ opsonofagoċitosi) għas- serotipi kollha tat- tilqima wara s - serje primarja.
Long- term persistence of antibodies has not been investigated after administration of a primary series in infants plus booster or after administration of single priming doses to older children.
Il- persistenza fit- tul tal- antikorpi ma kinitx investigata wara l- għoti ta ’ serje primarja fit- trabi flimkien ma ’ booster jew wara l- għoti ta ’ dożi priming waħidhom lil tfal ikbar.
Administration of unconjugated pneumococcal polysaccharides at 13 months following the primary series with Prevenar elicited an anamnestic antibody response for the 7 serotypes included in the vaccine, indicating that priming had occurred.
L- għoti ta ’ polysaccharides pnewmokokkali mhux konjugati fl- età ta ’ 13- il xahar wara s- serje primarja bi Prevenar, ikkawża rispons anamnestiku tal- antikorp għas- 7 serotipi inklużi fit- tilqima, li jindika li l - priming kien seħħ.
The immunogenicity of a two-dose primary series in infants plus a booster at about one year of age has been documented in several studies.
L- immunoġeniċità ta ’ serje primarja b’ żewġ dożi fit- trabi flimkien ma ’ booster bejn wieħed u ieħor fl - età ta ’ sena, kienet dokumentata f’ diversi studji.
Most of the data have indicated that smaller proportions of infants achieved antibody concentrations ≥ 0.35 μ g/ mL (the reference antibody concentration recommended by WHO) 1 against serotypes 6B and 23F after two-dose primary series when directly or indirectly compared with three-dose primary series.
Il- biċċa l- kbira tad- dejta indikat li porzjonijiet iżgħar ta ’ trabi laħqu konċentrazzjonijiet ta ’ antikorpi ta ’ ≥0. 35 μg/ ml (ir- referenza tal- konċentrazzjoni tal - antikorp rakkomandata mill- WHO) 1 kontra serotipi 6B u 23F wara serje primarja b’ żewġ dożi mqabbla direttament jew indirettament ma ’ serje primarja bi tliet dożi.
In addition, GMCs were lower for antibodies to most serotypes after a two- dose infant series than after a three-dose infant series.
Flimkien ma ’ dan, il- GMCs kienu iktar baxxi għall- antikorpi għall- biċċa l- kbira tas- serotipi wara serje tat- trabi b’ żewġ dożi milli b’ serje tat- trabi bi tliet dożi.
However, antibody responses to booster doses in toddlers following two-dose or three-dose infant series were comparable for all 7 vaccine serotypes and indicated that both infant regimens had elicited adequate priming.
Madankollu, ir- risponsi tal- antikorp għal dożi booster fit- trabi wara serje tat- trabi ta ’ żewġ dożi jew serje tat- trabi ta ’ tliet dożi kienu komparabbli għas- 7 serotipi kollha tat - tilqima u indikaw li ż- żewġ korsijiet tat- trabi kisbu priming adegwat.
Significant increases in antibody (measured by ELISA) to all vaccine serotypes were seen after administration of single doses of Prevenar to children aged 2 to 5 years.
Żidiet sinifikanti fl- antikorp (imkejla permezz ta ’ ELISA) għas- serotipi kollha tat- tilqima kienu osservati wara l- għoti ta ’ dożi waħidhom ta ’ Prevenar lil tfal li kellhom minn sentejn sa 5 snin.
Antibody concentrations were similar to those achieved following a three-dose infant series and a booster dose at less than 2 years of age.
Il - konċentrazzjonijiet tal- antikorp kienu simili għal dawk li nkisbu wara serje tat- trabi bi tliet dożi u doża (booster) li ngħataw lil trabi ta ’ inqas minn sentejn.
Efficacy trials in the 2- to 5-year-old population have not been conducted.
Ma sarux provi dwar l- effikaċja fil- popolazzjoni ta ’ pazjenti ta ’ minn sentejn sa 5 snin.
Clinical trial efficacy of the two-dose infant primary series plus a booster has not been established, and the clinical consequences of lower antibody concentrations against serotypes 6B and 23F after the two-dose infant series are not known.
L- effikaċja tal- prova klinika tas- serje primarja tat- trabi b’ żewġ dożi flimkien ma ’ booster, ma kinitx stabbilita, u l- konsegwenzi kliniċi ta ’ konċentrazzjonijiet iktar baxxi ta ’ antikorpi kontra serotipi 6B u 23F wara s- serje tat- trabi b’ żewġ dożi mhumiex magħrufa.
Efficacy against invasive disease
L- effikaċja kontra mard invażiv
Estimates of efficacy against invasive disease were obtained in the US population where vaccine serotype coverage ranged from 80 to 89%.
Stimi tal- effikaċja kontra mard invażiv inkisbu fil- popolazzjoni Amerikana, fejn il- kopertura tas - serotip tat- tilqima varjat minn 80 sa 89%.
Epidemiological data between 1988 and 2003 indicated that in Europe coverage is lower and varies from country to country.
Informazzjoni epidemjoloġika bejn is- sena 1988 u 2003 indikat li fl- Ewropa, il- kopertura hi iktar baxxa u tvarja minn pajjiż għall- ieħor.
Consequently, Prevenar should cover between 54% and 84% of isolates from invasive pneumococcal disease (IPD) in European children less than 2 years of age.
Konsegwentement, Prevenar għandu jkopri bejn 54% u 84% tal- iżolati minn mard pnewmokokkali invażiv (invasive pneumococcal disease - IPD) fi tfal Ewropej li għandhom inqas minn sentejn.
In European children between 2 to 5 years of age, Prevenar should cover about 62% to 83% of the clinical isolates responsible for invasive pneumococcal disease.
Fi tfal Ewropej ta ’ bejn sentejn u 5 snin, Prevenar għandu jkopri madwar 62% sa 83% tal- iżolati kliniċi responsabbli għal mard pnewmokokkali invażiv.
It is estimated that more than 80% of the antimicrobial resistant strains would be covered by the serotypes included in the vaccine.
Hu stmat li iktar minn 80% tar- razez reżistenti kontra l- mikrobi ser ikunu koperti mis- serotipi inklużi fit- tilqima.
The vaccine serotype coverage in the paediatric population decreases with increasing age.
Il- kopertura tas- serotip tat- tilqima fil- popolazzjoni pedjatrika tonqos hekk kif l- età tiżdied.
The decrease in the incidence of IPD seen in older children may be partly due to naturally acquired immunity.
It- tnaqqis fl- inċidenza ta ’ IPD li kienet osservata fi tfal akbar tista ’ tkun parzjalment minħabba l- immunità miksuba b’ mod naturali.
Efficacy against invasive disease was assessed in a large-scale randomised, double-blind, clinical trial in a multiethnic population in Northern California (Kaiser Permanente trial).
7 L- effikaċja kontra mard invażiv kienet evalwata fi prova fuq skala kbira, randomised, double- blind, f’ popolazzjoni multi- etnika f’ Kalifornja tat- Tramuntana (prova Kaiser Permanente).
More than 37,816 infants were immunised with either Prevenar or a control vaccine (meningococcal conjugate group C vaccine), at 2, 4, 6 and 12-15 months of age.
Iktar minn 37, 816 tarbija ngħataw tilqima jew bi Prevenar, jew b’ tilqima tal- kontroll (tilqima ta ’ grupp Ċ konjugat meningokokkali), wara 2, 4, 6 u 12- 15- il xahar.
At the time of the study, the serotypes included in the vaccine accounted for 89% of IPD.
Fiż- żmien tal- istudju, is- serotipi inklużi fit - tilqima ammontaw għal 89% tal- IPD.
A total of 52 cases of invasive disease caused by vaccine serotypes had accumulated in a blinded follow- up period through April 20, 1999.
Total ta ’ 52 każ ta ’ mard invażiv ikkawżat minn serotipi tat- tilqima, akkumula f’ perjodu blinded follow- up sal- 20 t’ April, 1999.
The estimate of vaccine serotype specific efficacy was 94% (95% CI:
L- istima ta ’ l- effikaċja speċifika għas- serotip tat- tilqima kienet ta ’ 94% (95% CI:
81, 99) in the intent-to-treat population and 97% (95% CI:
81, 99) fil- popolazzjoni intent- to- treat u 97% (95% CI:
85, 100) in the per protocol (fully immunized) population (40 cases).
85, 100) fil- popolazzjoni skont il - protokoll (imlaqqma b’ mod sħiħ) (40 każ).
In Europe, the estimates of effectiveness in children less than 2 years of age range from 51% to 79% when considering vaccine coverage against serotypes causing invasive disease.
Fl- Ewropa, l- istimi tal- effettività fit- tfal ta ’ inqas minn sentejn ivarjaw minn 51% sa 79% meta tikkunsidra l- kopertura tat- tilqima kontra serotipi li jikkawżaw mard invażiv.
Efficacy against pneumonia
L- effikaċja kontra l- pnewmonja
In the Kaiser Permanente trial, efficacy was 87.5% (95% CI:
Fil- prova Kaiser Permanente, l- effikaċja kienet ta ’ 87. 5% (95% CI:
7, 99) against bacteraemic pneumonia due to vaccine serotypes of S. pneumoniae.
7, 99) kontra l- pnewmonja batteremika minħabba s- serotipi tat- tilqima ta ’ S. pneumoniae.
7 Effectiveness (no microbiological confirmation of diagnosis was performed) against non-bacteraemic pneumonia was also assessed.
L- effettività (ma saret l- ebda konferma mikrobijoloġika tad- dijanjosi) kontra l- pnewmonja mhux batteremika kienet evalwata wkoll.
As many pathogens other than pneumococcal serotypes represented in the vaccine may contribute to the burden of pneumonia in children, protection against all clinical pneumonia is expected to be lower than for invasive pneumococcal disease.
Minħabba li ħafna patoġeni, ħlief is- serotipi pnewmokokkali rappreżentati fit- tilqima, jistgħu jikkontribwixxu għall- inċidenza tal- pnewmonja fit- tfal, il- protezzjoni kontra l- pnewmonja klinika kollha hi mistennija li tkun iktar baxxa milli għal mard pnewmokokkali invażiv.
In the per-protocol analysis, the estimated risk reduction for the first episode of clinical pneumonia with abnormal chest radiograph (defined as the presence of infiltrates beyond the perihilar area, consolidation, or empyema) was 20.5% (95% CI:
Fil- prova skont il- protokoll, it- tnaqqis fl- istima tar- riskju għall- ewwel episodju ta ’ pnewmonja klinika b’ x- ray anormali tas- sider (definit bħala l- preżenza ta ’ infiltrati lilhemm miż- żona perihilar, konsolidazzjoni, jew empijema) kien ta ’ 20. 5% (95% CI:
Reductions in pneumonia with abnormal chest radiograph were greatest in the first year of life (32.2%; 95% CI:
It- tnaqqis fil - pnewmonja b’ x- ray anormali tas- sider kien l- akbar fl- ewwel sena tal- ħajja (32. 2%; 95% CI:
3.3, 52.5) and in the first 2 years of life (23.4%; 95% CI:
3. 3, 52. 5) u fl- ewwel sentejn tal- ħajja (23. 4%; 95% CI:
Efficacy against otitis media
L- effikaċja kontra infjammazzjoni fil- parti tan- nofs tal- widna
Acute otitis media (AOM) is a common childhood disease with different aetiologies.
L- infjammazzjoni akuta fil- parti tan- nofs tal- widna (acute otitis media - AOM) hi marda komuni tat - tfulija b’ etjoloġiji differenti.
Bacteria can be responsible for 60-70% of clinical episodes of AOM.
Il- batterji jistgħu jkunu responsabbli għal 60- 70% tal- episodji kliniċi ta ’ AOM.
The pneumococcus is responsible for 30-40% of all bacterial AOM and a greater fraction of severe AOM.
Il- pnewmokokkus hu responsabbli għal 30- 40% tal- AOMs batterjali kollha u għal porzjon akbar ta ’ AOM severa.
Theoretically, Prevenar could prevent about 60- 80% of serotypes causing pneumococcal AOM.
Teoretikament, Prevenar jista ’ jevita madwar 60- 80% tas- serotipi li jikkawżaw AOM pnewmokokkali.
It is estimated that Prevenar could prevent 6-13% of all clinical episodes of AOM.
Hu stmat li Prevenar jista ’ jevita 6- 13% tal- episodji kliniċi kollha ta ’ AOM.
Efficacy of Prevenar against acute otitis media (AOM) was assessed in a randomised, double blind, clinical trial of 1,662 Finnish infants immunised with either Prevenar or a control vaccine (Hepatitis B vaccine), at 2, 4, 6 and 12-15 months of age.
L- effikaċja ta ’ Prevenar kontra infjammazzjoni akuta fil- parti tan- nofs tal- widna (acute otitis media - AOM) kienet evalwata fi prova klinika randomised, double blind, fuq 1, 662 tarbija Finlandiżi li ngħataw tilqima jew bi Prevenar, jew b’ tilqima tal- kontroll (tilqima kontra l- Epatite B), wara 2, 4, 6 u 12- 15- il xahar ta ’ età.
The estimate for vaccine efficacy against vaccine-serotype AOM, the primary endpoint of the trial, was 57% (95% CI:
L- istima għall- effikaċja tat- tilqima kontra t- tilqima- serotip AOM, ir- riżultat aħħari primarju tal- prova, kienet ta ’ 57% (95% CI:
44, 67) in the per-protocol analysis and 54% (95% CI:
44, 67) fl- analiżi skont il- protokoll u 54% (95% CI:
41, 64) in the intent-to-treat analysis.
41, 64) fl- analiżi intent- to- treat.
A 33% (95% CI: -1, 80) increase in AOM due to serogroups not included in the vaccine was observed in immunised subjects.
Żieda ta ’ 33% (95% CI: - 1, 80) fl- AOM minħabba serogruppi li ma kinux inklużi fit- tilqima kienet osservata f’ pazjenti immunizzati.
However, the overall benefit was a 34% (95% CI:
Madankollu, il- benefiċċju totali kien ta ’ tnaqqis ta ’ 34% (95% CI:
21, 45) reduction in the incidence of all pneumococcal AOM.
21, 45) fl- inċidenza tal- AOMs pnewmokokkali kollha.
The impact of the vaccine on total number of episodes of otitis media regardless of etiology was a 6% (95% CI: -4, 16) reduction.
L- impatt tat - tilqima fuq in- numru totali ta ’ episodji ta ’ infjammazzjoni fil- parti tan- nofs tal- widna irrispettivament mill- etjoloġija kien ta ’ tnaqqis ta ’ 6% (95% CI: - 4, 16).
A subset of children in this study were followed until they reached 4 to 5 years of age.
Sottosett ta ’ tfal f’ dan l- istudju kienu segwiti sakemm kellhom minn 4 sa 5 snin.
In this follow-up, vaccine efficacy for frequent OM (defined as at least 3 episodes within 6 months) was 18% (95% CI:
F’ dan il- follow- up, l - effikaċja tat- tilqima għal OM frekwenti (definita bħala mill- anqas 3 episodji fi żmien 6 xhur) kienet ta ’ 18% (95% CI:
1, 32), for chronic otitis media with effusion, 50% (95% CI:
1, 32), għal infjammazzjoni kronika fil- parti tan- nofs tal- widna b’ effużjoni, 50% (95% CI:
15, 71), and for tympanostomy tube placement, 39% (95% CI:
15, 71), u għat- tqegħid ta ’ tubu tat- timpanostomija, 39% (95% CI:
Efficacy of Prevenar against AOM was assessed as a secondary endpoint in the Kaiser Permanente trial.
L- effikaċja ta ’ Prevenar kontra AOM kienet evalwata bħala riżultat aħħari sekondarju fil- prova Kaiser Permanente.
Children were followed until 3.5 years of age.
It- tfal kienu segwiti sa meta kellhom 3. 5 snin.
The impact of the vaccine on total number of episodes of otitis media regardless of etiology was a 7% reduction (95% CI:
L- impatt tat- tilqima fuq in- numru totali ta ’ episodji ta ’ infjammazzjoni fil- parti tan- nofs tal- widna irrispettivament mill- etjoloġija kien ta ’ tnaqqis ta ’ 7% (95% CI:
The effect of the vaccine in the per-protocol analysis was a 9% reduction (95% CI:
L- effett tat- tilqima fl- analiżi skont il- protokoll kien tnaqqis ta ’ 9%
3, 15) in recurrent AOM (defined as 3 episodes in six months or 4 episodes in one year) or a 23% (95% CI:
3, 15) f’ AOM rikorrenti (definita bħala 3 episodji f’ sitt xhur jew 4 episodji f’ sena) jew tnaqqis ta ’ 23% (95% CI: