natgillin/translations-raw huggingface dataset:
Farmakoterapeutisk klassifikation: rotavirus- diaré- vacciner, ATC- kode:
Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code:
Beskyttelseseffektivitet
Protective efficacy
Der er udført kliniske forsøg i Europa og Latinamerika for at undersøge beskyttelseseffektiviteten af Rotarix mod hvilken som helst og alvorlig rotavirus gastro- enteritis.
Clinical studies have been conducted in Europe and Latin America to evaluate the protective efficacy of Rotarix against any and severe rotavirus gastro-enteritis.
I et klinisk forsøg i Europa blev Rotarix undersøgt og givet i overensstemmelse med forskellige europæiske programmer (2, 3 måneder; 2, 4 måneder; 3, 4 måneder; 3, 5 måneder) til 4. 000 personer.
A clinical study performed in Europe evaluated Rotarix given according to different European schedules (2, 3 months; 2, 4 months; 3, 4 months; 3, 5 months) in 4000 subjects.
Alvorlighed af gastro- enteritis blev defineret i henhold til Vesikari 20- point skala, som vurderer det samlede billede af rotavirus gastro- enteritis ved at vurdere alvorlighed og varighed af diaré og opkastning, alvorligheden af feber og dehydrering såvel som behov for behandling.
Severity of gastro- enteritis was defined according to the Vesikari 20-point scale which evaluates the full clinical picture of rotavirus gastro-enteritis by taking into account the severity and duration of diarrhoea and vomiting, the severity of fever and dehydration as well as the need for treatment.
1. leveår
1st year of life
2. leveår
2nd year of life
Rotarix N = 2. 572;
Rotarix N=2572;
Rotarix N = 2. 554;
Rotarix N=2554;
Placebo N = 1. 302 (§)
Placebo N=1302 (§)
Placebo N = 1. 294 (§)
Placebo N=1294 (§)
Effekt (%) mod alle og alvorlig rotavirus gastro- enteritis [95% CI] Type
Vaccine efficacy (%) against any and severe rotavirus gastro-enteritis [95% CI]
Alle
Any severity
Alvorlige † Alle
Severe† Any se
Alle Alvorlige † Alle
Any severity Severe† Any severity
Alvorlige †
Severe†
[67, 8; 91, 3] [86, 2;
[67.8; 91.3]
99, 6]
[86.2; 99.6]
62, 0
62.0 [< 0.0; 94.4]
74, 7
74.7 [< 0.0; 99.6]
57, 1 *
89.9* [9.4; 99.8]
89, 9 *
G3P[8]
[< 0, 0; 94, 4] [< 0, 0;
89.9* [9.5; 99.8]
99, 6] [< 0, 0; 82, 6]
79.7* [< 0.0; 98.1]
[9, 4; 99, 8]
83.1 [< 0.0; 99.7]
G3P[ 8]
G4P[8]
89, 9 *
100* [64.9; 100]
100 * 79, 7 *
69.6 [< 0.0; 95.3]
83, 1
G9P[8]
[9, 5; 99, 8]
94.7* [77.9; 99.4]
[44, 8; 100]
70.5* [50.7; 82.8]
[< 0, 0; 98, 1] [< 0, 0; 99, 7]
76.8* [50.8; 89.7]
G4P[ 8]
Strains with P[8]
88, 3 *
75.7*
100 *
87.5*
69, 6 87, 3 *
genotype
[57, 5; 97, 9]
[80.8; 93.0]
[64, 9; 100]
[90.6; 99.1]
[< 0, 0; 95, 3] [< 0, 0; 99, 7]
[65.0; 83.4]
G9P[ 8]
[77.8; 93.4]
75, 6 *
71.9*
94, 7 *
85.6*
70, 5 * 76, 8 *
rotavirus strains
[51, 1; 88, 5]
[79.6; 92.1]
[77, 9; 99, 4]
[89.6; 98.7]
[50, 7; 82, 8] [50, 8:
[61.2; 79.8]
89, 7]
[75.8; 91.9]
Stammer med P[ 8] genotype Cirkulerende rotavirus - stammer
Vaccine efficacy (%) against rotavirus gastro-enteritis requiring medical attention [95% CI]
96, 5 * [90, 6; 99, 1] 95, 8 * [89, 6; 98, 7]
6
75, 7 * 87, 5 * [65, 0; 83, 4] [77, 8; 93, 4] 71, 9 * 85, 6 * 61, 2; 79, 8] [75, 8; 91, 9]
Circulating
stammer
rotavirus strains
Effekt (%) mod rotavirus gastro- enteritis, som kræver hospitalisering [95% CI] Cirkulerende rotavirus -
Vaccine efficacy (%) against hospitalisation due to rotavirus gastro-enteritis [95% CI]
stammer †
†
Alvorlig gastro- enteritis er defineret ved en score ≥ 11 på Vesikari- skalaen (§) ATP kohorte for effekt * Statistisk signifikans (p < 0, 05)
Severe gastro-enteritis defined as a score ≥11 on the Vesikari scale (§) ATP cohort for efficacy * Statistically significant (p < 0.05)
Effekten i første leveår stiger progressivt med stigende alvorlighed af sygdom, indtil 100% (95% CI:
Vaccine efficacy during the first year of life progressively increased with increasing disease severity, reaching 100% (95% CI:
84, 7; 100) for Vesikari- score ≥ 17.
84.7;100) for Vesikari scores ≥17.
Der er blevet udført et klinisk forsøg for Rotarix i Latinamerika, som involverede mere end 20. 000 personer.
A clinical study performed in Latin America evaluated Rotarix in more than 20000 subjects.
Alvorligheden af gastro- enteritis blev defineret efter WHOs kriterier.
Severity of gastro-enteritis was defined according to WHO criteria.
Graden af beskyttelse efter vaccination mod alvorlig rotavirus gastro- enteritis krævende hospitalisering og/ eller medicinsk behandling af dehydrering versus effektiviteten af vaccinen efter 2 doser af Rotarix er angivet i tabellen nedenfor.
The protective vaccine efficacy against severe rotavirus gastro-enteritis requiring hospitalisation and/or rehydration therapy in a medical facility and the type specific vaccine efficacy after two doses of Rotarix are presented in the table below:
7 Type
Type
Alvorlig rotavirus gastro - enteritis (1. leveår) Rotarix N = 9. 009; Placebo N = 8. 858 (§) Effekt (%) 95% CI
Severe rotavirus gastro- enteritis (1st year of life) Rotarix N=9009; Placebo N=8858(§) Efficacy (%) [95% CI]
Alvorlig rotavirus gastro - enteritis (2. leveår) Rotarix N = 7. 175; Placebo N = 7. 062 (§) Effekt (%) 95% CI
Severe rotavirus gastro- enteritis (2nd year of life) Rotarix N=7175; Placebo N=7062 (§) Efficacy (%) [95% CI]
Stammer med P[ 8] genotype (§) ATP kohorte for effekt
Strains with P[8] genotype
* Statistisk signifikans (p < 0, 05) # Meget lille antal tilfælde, hvorpå den estimerede effect mod G4P[ 8] er baseret, (1 tilfælde i Rotarix - gruppen og 2 tilfælde i placebogruppen).
(§) ATP cohort for efficacy * Statistically significant (p < 0.05) # The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very small (1 case in the Rotarix group and 2 cases in the placebo group).
20, 1; 91, 1) effektivitet mod alvorlig rotavirus gastro- enteritis (Vesikari- score > 11) forårsaget af rotavirus type G2P[ 4] i løbet af det første leveår. * I disse undersøgelser var punktestimater og konfidensintervaller henholdsvis:
A pooled analysis of five efficacy studies*, showed a 71.4% (95% CI:20.1;91.1) efficacy against severe rotavirus gastro-enteritis (Vesikari score ≥11) caused by rotavirus G2P[4] type during the first year of life. * In these studies, the point estimates and confidence intervals were respectively:
100% (95% CI: - 1. 858, 0; 100), 100% (95% CI:
100% (95% CI: - 1858.0;100), 100% (95% CI:
21, 1; 100) 45, 4% (95% CI: - 81, 5; 86, 6), 74, 7 (95% CI: - 386, 2; 99, 6).
21.1;100), 45.4% (95% CI: -81.5;86.6), 74.7 (95% CI :-386.2;99.6).
Intet punktestimat foreligger for resten af forsøget.
No point estimate was available for the remaining study.
Den immunologiske mekanisme, hvorved Rotarix virker mod rotavirus gastro- enteritis, er ikke fastlagt fuldstændigt.
The immunologic mechanism by which Rotarix protects against rotavirus gastro-enteritis is not completely understood.
Der er ikke etableret en sammenhæng mellem antistofkoncentration opnået ved rotavirus- vaccination og beskyttelse mod rotavirus gastro- enteritis.
A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastro-enteritis has not been established.
Følgende tabel viser procentdelen af personer med serum anti- rotavirus IgA- antistoftiter > 20 U/ ml (ved ELISA) 1- 2 måneder efter anden vaccinedosis henholdsvis placebo i forskellige forsøg.
7 The following table shows the percentage of subjects with serum anti-rotavirus IgA antibody titers ≥ 20U/ml (by ELISA) one to two months after the second dose of vaccine or placebo as observed in different studies.
Forsøg udført i
Studies conducted in
% N ≥ 20 U/ ml [95% CI]
% ≥ 20U/ml [95% CI]
% ≥ 20 U/ ml [95% CI]
% ≥ 20U/ml [95% CI]
Frankrig,
France, Germany
Finland,
Finland, Italy
94, 4
94.4 [90.0;97.3]
[90, 0; 97, 3]
3.5 [1.0;8.7]
Latinamerika;
Latin America; 11 countries
[11, 7; 19, 0]
15.1% [11.7;19.0]
Pulver Saccharose Dextran Sorbitol Aminosyrer Dulbecco’ s Modified Eagle Medium (DMEM)
Powder Sucrose Dextran Sorbitol Amino acids Dulbecco’s Modified Eagle Medium (DMEM)
Solvens Calciumcarbonat Xanthangummi Sterilt vand
Solvent Calcium carbonate Xanthan gum Sterile water
Efter rekonstituering skal vaccinen anvendes med det samme.
8 After the reconstitution, the vaccine should be administered immediately.
Eksperimentelle data viser, at den rekonstituerede vaccine er stabil i 24 timer ved almindelig opbevaring (18 ○C – 25 ○C).
However, experimental data have shown that the reconstituted vaccine is stable when stored for 24 hours at ambient temperature (18-25°C).
Disse data er ikke anbefalinger for opbevaring.
These data are not recommendations for storage.
Opbevares i den originale pakning, for at beskytte mod lys.
Store in the original package, in order to protect from light.
I tilfælde af midlertidig opbevaring af pulver og solvens uden for køleskab, viser data, at såvel pulver som solvens er stabilt, når det opvares ved temperaturer op til 37 °C i en 1 uge.
In case of temporary storage of the powder and the solvent outside the refrigerator, experimental data have shown that the powder as well as the solvent are stable when stored at temperatures up to 37°C for 1 week.
For opbevaringsforhold for det rekonstituerede lægemiddel, se pkt.
For storage conditions of the reconstituted product, see section 6.3.
6. 3.
6.5 Nature and contents of container
9 6. 5 Emballagetype og pakningsstørrelser
Transfer adapter for reconstitution (1/dose) in the following pack sizes:
1 dosis pulver i glasbeholder (type I glas) med prop (butylgummi).
- pack size of 1 glass container of powder plus 1 oral applicator of solvent
1 ml solvens i oral applikator (type I glas) med en stempelprop og en beskyttelseshætte (butylgummi).
- pack size of 5 glass containers of powder plus 5 oral applicators of solvent
Overførselsanordning til rekonstituering (1/ dosis) i følgende pakningsstørrelser: • pakning med 1 glasbeholder med pulver plus 1 oral applikator med solvens • pakning med 5 glasbeholdere med pulver plus 5 orale applikatorer med solvens • pakning med 10 glasbeholdere med pulver plus 10 orale applikatorer med solvens • pakning med 25 glasbeholdere med pulver plus 25 orale applikatorer med solvens
- pack size of 10 glass containers of powder plus 10 oral applicators of solvent
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
- pack size of 25 glass containers of powder plus 25 oral applicators of solvent
Både før og efter omrystning skal solvensen undersøges visuelt for fremmede partikler og/ eller udsædvanligt udseende.
The solvent should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to reconstitution.
Den rekonstituerede vaccine skal også, undersøges visuelt for fremmede partikler og/ eller udsædvanligt udseende inden administration.
The reconstituted vaccine should also be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Fjern plastikforseglingen fra glasbeholderen, der indeholder pulveret 2.
2.
Sæt overførselsaggregatet på glasbeholderen ved at skubbe det nedad indtil det sidder rigtigt og er fast placeret 3.
3.
Ryst den orale applikator med solvens kraftigt.
Shake the oral applicator containing the solvent vigorously.
Den omrystede suspension vil være en uklar væske med et langsomt bundfældende hvidt bundfald.
The shaken suspension will appear as a turbid liquid with a slow settling white deposit.
Fjern proppen fra den orale applikator 5.
Remove the protective tip cap from the oral applicator.
Forbind den orale applikator med overførselsaggregat ved et solidt skub på aggregatet 6.
Connect the oral applicator into the transfer adapter by pushing it firmly on this device.
Overfør hele den orale applikators indhold i glasbeholderen der indeholder pulveret 7.
Transfer the entire content of the oral applicator into the glass container containing the powder.
Ryst glasbeholderen, der stadig er forbundet med den orale applikator og undersøg for pulverets fuldstændige opslæmning.
With the oral applicator still attached, shake the glass container and examine it for complete suspension of the powder.
Dette er normalt.
This appearance is normal.
Træk hele blandingen tilbage i den orale applikator 9.
9 9.
Fjern den orale applikator fra overførselsaggregatet 10.
10.
Vaccinen er kun til oral administration.
This vaccine is for oral administration only.
Administrer hele indholdet af den orale applikator oralt (indgiv hele indholdet af den orale applikator på indersiden af kinden).
Administer the entire content of the oral applicator orally (by administering the entire content of the oral applicator on the inside of the cheek).
Hvis den rekonstituerede vaccine skal opbevares midlertidigt inden administration, skal den orale applikator påsættes beskyttelseshætten.
If the reconstituted vaccine is to be stored temporarily before administration, replace the protective tip cap on the oral applicator.
Den orale applikator med den rekonstituerede vaccine bør rystes forsigtigt igen før oral administration.
The oral applicator containing the reconstituted vaccine should be shaken gently again before oral administration.
10 Overførsels - aggregat
Transfer adapter
Beskyttelses - hætte til den orale applikator
Oral applicator Tip-Cap
Fjern plastikforseglingen fra
Remove the plastic cover from the glass container containing the powder
Sæt overførselsaggregatet på
Connect the transfer adapter onto the glass container by pushing it downwards until the transfer adapter is properly and securely placed
Omryst kraftigt den orale applikator
Shake the oral applicator containing the solvent vigorously.
suspension vil fremstå som en uklar væske med et langsomt sættende hvidt bundfald.
The shaken suspension will appear as a turbid liquid with a slow settling white deposit
Forbind den orale applikator med overførselsaggregatet ved et fast pres på aggregatet.
Connect the oral applicator into the transfer adapter by pushing it firmly on this device
Overfør hele den orale applikator indhold til glasbeholderen med frysetørret pulver.
Transfer the entire content of the oral applicator into the glass container containing the powder
Barnet bør sidde i en tilbagelænet stilling.
The child should be seated in a reclining position.
Indgiv hele indholdet af den orale applikator via munden (indgiv hele indholdet af den orale applikator på indersiden af kinden).
Administer the entire content of the oral applicator orally (by administering the entire content of the oral applicator on the inside of the cheek)
Må ikke injiceres.
not inject.
EU/ 01/ 05/ 330/ 001 EU/ 01/ 05/ 330/ 002 EU/ 01/ 05/ 330/ 003 EU/ 01/ 05/ 330/ 004
EU/1/05/330/001 EU/1/05/330/002 EU/1/05/330/003 EU/1/05/330/004
Dato for først MT 21. februar 2006
21 February 2006
Rotarix oral suspension i fyldt oral applikator Rotavirus- vaccine, levende
Rotarix oral suspension in pre-filled oral applicator Rotavirus vaccine, live
1 dosis (1, 5 ml) indeholder:
1 dose (1.5ml) contains:
4. 4)
This product contains sucrose 1073 mg (see section 4.4).
Oral suspension.
Oral suspension.
4. 4 og 5. 1).
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of types G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8] (see sections 4.4 and 5.1).
Der er ingen data med hensyn til sikkerhed, immunogenicitet eller effektivitet, hvis Rotarix gives som første dosis og en anden rotavirus- vaccine gives som anden dosis eller vice versa.
There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa.
2 Rotarix er kun til oral anvendelse.
12 Rotarix is for oral use only.
Ved hjælp af ELISA blev der målt antigener i 50% af afføringerne efter første dosis af Rotarix (frysetørret pulver og solvens) og i 4% efter anden dosis.
Viral antigen particles detected by ELISA were found in 50% of stools after the first dose of Rotarix lyophilised formulation and 4% of stools after the second dose.
I to sammenlignende kontrollerede forsøg var udskillelsen efter administration af Rotarix (suspension) sammenlignelig med, hvad der blev set efter administration af Rotarix (frysetørret pulver og solvens).
In two comparative controlled trials, vaccine shedding after vaccination with Rotarix liquid formulation was comparable to that observed after vaccination with Rotarix lyophilised formulation.
Personer i kontakt med nylig vaccinerede, bør rådes til at overholde personlig hygiejne (f. eks. vaske deres hænder efter bleskift).
Contacts of recent vaccinees should observe personal hygiene (e.g. wash their hands after changing child’s nappies).
Den potentielle risiko for apnø og behov for repiratorisk overvågning i 48- 72 timer bør overvejes ved primære immuniseringsprogrammer til meget tidligt fødte børn (fødsel ≤ uge 28 af svangerskabet) og specielt for tidligere respiratorisk immature børn.
13 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.
3 Da fordelene ved vaccination er stor for denne gruppe børn, bør vaccination ikke udelades eller forsinkes.
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Vaccinen indeholder hjælpestoffet saccharose.
The vaccine contains sucrose as an excipient.
Rotarix kan gives samtidigt med alle følgende monovalente eller kombinerede vacciner [inklusive hexavalente vacciner (DTPa- HBV- IPV/ Hib)]: difteri- tetanus- helcelle pertussis- vaccine (DTPw), diphtheria- tetanus- acellulær pertussis- vaccine (DTPa), Haemophilus influenzae type b- vaccine (Hib), inactiveret polio- vaccine (IPV), hepatitis B- vaccine (HBV), konjugeret pneumokok- vaccine og serotype C konjugeret meningokok- vaccine.
Rotarix can be given concomitantly with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-whole cell pertussis vaccine (DTPw), diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine.
Samtidig administration af Rotarix og oral polio vaccine (OPV) påvirker ikke immunresponset overfor de forskellige polio- antigener.
Concominant administration of Rotarix and oral polio vaccine (OPV) does not affect the immune response to the polio antigens.
Immunresponset overfor Rotarix er upåvirket, når OPV gives to uger fra Rotarix.
Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was shown to be maintained in a clinical trial involving more than 4200 subjects who received Rotarix concomitantly with OPV.
Der er ingen restriktioner med hensyn til barnets indtagelse af mad eller væske, inklusive brystmælk, hverken før eller efter vaccination.
There are no restrictions on the infant’s consumption of food or liquid, either before or after vaccination.
• Kliniske forsøg med lægemiddelformen frysetørret pulver og solvens:
14 • Clinical trials for the lyophilised formulation
40. 200 børn.
In a total of eleven placebo-controlled clinical trials, approximately 77800 doses of Rotarix lyophilised formulation were administered to approximately 40200 infants.
I to kliniske forsøg (Finland) blev Rotarix (frysetørret pulver og solvens) administreret alene (administration af rutine børnevacciner blev forskudt).
In two clinical trials (Finland), Rotarix lyophilised formulation was administered alone (administration of routine paediatric vaccines was staggered).
4 appetit, feber og irritabilitet i den gruppe, der fik Rotarix, var ikke forskellig fra den gruppe, der fik placebo.
The incidence of diarrhoea, vomiting, loss of appetite, fever and irritability was not different in the group receiving Rotarix when compared to the group receiving placebo.
Der sås ingen stigning i forekomst eller alvorlighed efter anden dosis.
No increase in the incidence or severity of these reactions was seen with the second dose.
I de ni andre kliniske forsøg (Europa, Canada, USA, Latinamerika, Singapore, Sydafrika) blev Rotarix (frysetørret pulver og solvens) administreret samtidigt med andre pædiatriske vacciner (se pkt.
In the remaining nine trials (Europe, Canada, USA, Latin America, Singapore, South-Africa), Rotarix lyophilised formulation was co-administered with routine paediatric vaccines (see section 4.5).
(≥ 1/ 10) (≥ 1/ 100 til, < 1/ 10) (≥ 1/ 1. 000 til, < 1/ 100) (≥ 1/ 10. 000 til, < 1/ 1. 000)
Very common (≥1/10) Common (≥1/100, < 1/10) Uncommon (≥1/1,000, < 1/100) Rare (≥1/10,000, < 1/1,000)
Dermatitis, udslæt
Skin and subcutaneous tissue disorders Rare: dermatitis, rash
Muskelkramper
Musculoskeletal and connective tissue disorders Rare: muscle cramp
Infektion i øvre luftveje
Infections and infestations Rare: upper respiratory tract infection
Feber, træthed
General disorders and administration site conditions Common: fever, fatigue
Denne undersøgelse viste, at der ikke er nogen øget risiko for invagination i Rotarixgruppen sammenlignet med placebogruppen.
This trial gave evidence of no increased risk of intussusception in the Rotarix group when compared with the placebo group as shown in the table below.
Invagination inden 31
15 Intussusception within 31 days after administration of:
Rotarix (N = 31. 673)
Rotarix N=31673
Placebo (N = 31. 552)
Placebo N=31552
risiko (95% CI *)
Relative risk (95% CI*)
Første dosis Anden dosis * CI: konfidensinterval
First dose Second dose *CI: confidence interval
• Post marketing overvågning af lægemiddelformen frysetørret pulver og solvens:
• Post marketing surveillance for the lyophilised formulation:
5 Luftveje, thorax og mediastinum:
Respiratory, thoracic and mediastinal disorders:
• Kliniske forsøg med lægemiddelformen suspension
• Clinical trials for the liquid formulation
1. 930 børn.
In a total of four clinical trials, approximately 3800 doses of Rotarix liquid formulation were administered to approximately 1930 infants.
Disse forsøg har vist, at sikkerhed og reaktogenicitetsprofilen af suspensionen er samstemmende med lægemiddelformen frysetørret pulver og solvens.
Those trials have shown that the safety and reactogenicity profile of the liquid formulation is comparable to the lyophilised formulation.
Beskyttelseseffektivitet for lægemiddelformen frysetørret pulver og solvens
Protective efficacy of the lyophilised formulation
Alle
Type
Alvorlige † Alle
Any severity
Alle Alvorlige † Alle
Severe† Any sev
Alvorlige †
Any severity Severe† Any severity
G1P[ 8]
Severe†
95, 6 *
G1P[8]
96, 4 *
95.6*
82, 7 *
96.4*
96, 5 *
82.7*
[87, 9; 98, 8]
96.5*
[85, 7; 99, 6]
[87.9;98.8]
[67, 8; 91, 3] [86, 2;
[85.7;99.6]
G2P[ 4]
[67.8;91.3]
57, 1 *
[86.2;99.6]
89, 9 *
G2P[4]
[< 0, 0; 94, 4] [< 0, 0;
62.0 [< 0.0;94.4]
99, 6] [< 0, 0; 82, 6]
74.7 [< 0.0;99.6]
G3P[ 8]
89.9* [9.4;99.8]
100 * 79, 7 *
89.9* [9.5;99.8]
[44, 8; 100]
83.1 [< 0.0;99.7]
[< 0, 0; 98, 1] [< 0, 0; 99, 7]
G4P[8]
G4P[ 8]
88.3*
88, 3 *
100*
100 *
69.6
69, 6 87, 3 *
[57.5;97.9]
[57, 5; 97, 9]
[64.9;100]
[64, 9; 100]
[< 0.0 ;95.3]
[< 0, 0; 95, 3] [< 0, 0; 99, 7]
[< 0.0;99.7]
75, 6 *
94.7*
94, 7 *
70.5*
70, 5 * 76, 8 *
76.8*
[51, 1; 88, 5]
[51.1;88.5]
[77, 9; 99, 4]
[77.9;99.4]
[50, 7; 82, 8] [50, 8:
[50.7;82.8]
89, 7]
[50.8;89.7]
Stammer med P[ 8] genotype Cirkulerende rotavirus - stammer
Strains with P[8] genotype Circulating rotavirus strains
88, 2 * [80, 8; 93, 0] 87, 1 * [79, 6; 92, 1]
96.5* [90.6;99.1] 95.8* [89.6;98.7]
96, 5 * [90, 6; 99, 1] 95, 8 * [89, 6; 98, 7]
75.7* [65.0;83.4] 71.9* [61.2;79.8]
75, 7 * 87, 5 * [65, 0; 83, 4] [77, 8; 93, 4] 71, 9 * 85, 6 * 61, 2; 79, 8] [75, 8; 91, 9]
87.5* [77.8;93.4] 85.6* [75.8;91.9]
Effekt (%) mod rotavirus gastro- enteritis, som kræver medicinsk behandling [95% CI] Cirkulerende rotavirus -
Vaccine efficacy (%) against rotavirus gastro-enteritis requiring medical attention [95% CI]
Alvorligheden af gasro- enteritis blev defineret efter WHOs kriterier.
Severity of gastro-enteritis was defined according to WHO criteria.