natgillin/translations-raw huggingface dataset:
HPV 16 og HPV 18 antages at være ansvarlige for cirka 70% af tilfældene af cancer i livmoderhalsen, 80% af tilfældene af adenocarcinoma in situ (AIS), 45- 70% af tilfældene af high- grade cervikal intraepithelial neoplasi (CIN 2/ 3), 25% af tilfældene af low- grade cervikal intraepithelial neoplasi (CIN 1), cirka 70% af tilfældene af HPV- relaterede high- grade intraepitheliale neoplasier i vulva (VIN 2/ 3) og intraepitheliale neoplasier i vagina (VaIN 2/ 3).
HPV 16 and HPV 18 are estimated to be responsible for approximately 70% of cervical cancers; 80% of adenocarcinoma in situ (AIS); 45-70% of high-grade cervical intraepithelial neoplasia (CIN 2/ 3); 25% of low grade cervical intraepithelial neoplasia (CIN 1); approximately 70% of HPV related high- grade vulvar (VIN 2/ 3) and vaginal (VaIN 2/ 3) intraepithelial neoplasia.
HPV 6 og 11 er ansvarlige for cirka 90% af alle kønsvorter og 10% af tilfældene af low- grade cervikal intraepithelial neoplasi (CIN 1).
HPV 6 and 11 are responsible for approximately 90% of genital warts and 10% of low grade cervical intraepithelial neoplasia (CIN 1).
CIN 3 og AIS er blevet accepteret som en umiddelbar precursor for invasiv cancer i livmoderhalsen.
CIN 3 and AIS have been accepted as immediate precursors of invasive cervical cancer.
4. 1, referere til high- grade cervikal intraepithelial neoplasi (CIN 2/ 3), high- grade vulva intraepithelial neoplasi (VIN 2/ 3) og high- grade vaginal intraepithelial neoplasi (VaIN 2/ 3).
The term "premalignant genital lesions" in section 4.1 corresponds to high-grade cervical intraepithelial neoplasia (CIN 2/ 3), high-grade vulvar intraepithelial neoplasia (VIN 2/ 3) and high- grade vaginal intraepithelial neoplasia (VaIN 2/ 3).
Kliniske undersøgelser
Clinical Studies
Forsøgene inkluderede 20. 541 16 - til 26- årige kvinder, der blev inkluderet og vaccineret uden forudgående screening for tilstedeværelsen af HPV infektion.
The efficacy of Gardasil was assessed in 4 placebo-controlled, double-blind, randomized Phase II and III clinical studies including a total of 20,541 16- to 26-year old women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
HPV 16 - eller 18- relateret CIN 2/ 3 og AIS (Protokol 015, FUTURE II), HPV 6 -, 11 -, 16 -, eller 18- relateret persisterende infektion (Protokol 007) og HPV 16- relateret persisterende infektion (Protokol 005).
The primary efficacy endpoints included HPV 6-, 11-, 16-, or 18-related vulvar and vaginal lesions (genital warts, VIN, VaIN) and CIN of any grade (Protocol 013, FUTURE I), HPV 16- or 18-related CIN 2/ 3 and AIS (Protocol 015, FUTURE II), HPV 6-, 11-, 16-, or 18-related persistent infection (Protocol 007), and HPV 16-related persistent infection (Protocol 005).
Effektresultaterne præsenteres for den kombinerede analyse af undersøgelsesprotokollerne.
Efficacy results are presented for the combined analysis of study protocols.
Effekten over for HPV 16/ 18- relateret CIN 2/ 3 eller AIS er baseret på data fra protokollerne 005 (kun 16 - relaterede effektmål), 007, 013 og 015.
The efficacy for HPV 16/ 18 related CIN 2/ 3 or AIS is based on data from protocols 005 (16-related endpoints only), 007, 013, and 015.
Effekten for så vidt angår alle øvrige endpoints er baseret på protokollerne 007, 013 og 015.
The efficacy for all other endpoints is based on protocols 007, 013, and 015.
6 og 3, 0 år for henholdsvis protokol 005, protokol 007, protokol 013 og protokol 015.
The median duration of follow-up for these studies was 4.0, 3.0, 3.0, and 3.0 years for Protocol 005, Protocol 007, Protocol 013, and Protocol 015, respectively.
Middelvarigheden for opfølgning i de kombinerede protokoller (005, 007, 013 og 015) var 3, 6 år.
The median duration of follow-up for the combined protocols (005, 007, 013, and 015) was 3.6 years.
Resultater fra individuelle undersøgelser understøtter resultaterne fra den kombinerede analyse.
Results of individual studies support the results from the combined analysis.
Gardasil var effektiv imod HPV- sygdom forårsaget af hver af de fire vaccine- HPV- typer.
Gardasil was efficacious against HPV disease caused by each of the four vaccine HPV type.
Efter afslutning af undersøgelsen blev de forsøgspersoner, der var rekrutteret til de to fase III- undersøgelser (protokol 013 og protokol 015), fulgt i op til 4 år (middelvarighed 3, 7 år).
At end of study, subjects enrolled in the two Phase-III studies (Protocol-013 and Protocol-015), were followed for up to 4 years (median 3.7 years).
Cervikal intraepithelial neoplasi (CIN) grade 2/ 3 (moderat til high- grade dysplasi) og adenocarcinoma in situ (AIS) blev anvendt i de kliniske undersøgelser som en surrogatmarkør for cervikal cancer.
6 Cervical Intraepithelial Neoplasia (CIN) Grade 2/ 3 (moderate to high-grade dysplasia) and adenocarcinoma in situ (AIS) were used in the clinical trials as a surrogate marker for cervical cancer.
Profylaktisk effekt imod vaccine- HPV- typer (HPV 6, 11, 16 eller 18)
Prophylactic Efficacy against Vaccine HPV Types (HPV 6, 11, 16, or 18)
De primære effektanalyser for så vidt angår vaccine- HPV- typer (HPV 6, 11, 16 og 18) blev udført i per- protokol effektpopulationen (PPE) (n = alle tre vaccinationer inden for 1 år efter rekruttering, ingen væsentlige afvigelser fra undersøgelsesprotokollen, og naive over for de( n) relevante HPV - type( r) forud for første dosis og indtil 1 måned efter tredje dosis (måned 7).
The primary analyses of efficacy, with respect to vaccine HPV types (HPV 6, 11, 16, and 18), were conducted in the per-protocol efficacy (PPE) population (n= all 3 vaccinations within 1 year of enrolment, no major protocol deviations and naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7)).
Måling af effekt blev påbebegyndt efter måned 7’ s kontrolbesøg.
Efficacy was measured starting after the Month 7 visit.
I alt var 73% af forsøgspersonerne naive (PCR- negative og seronegative) over for alle 4 HPV- typer på rekrutteringstidspunktet.
Overall, 73% of subjects were naïve (PCR negative and seronegative) to all 4 HPV types at enrolment.
Effekt på forsøgspersoner, der var naive over for de( n) relevante vaccine- HPV- type( r)
Efficacy in subjects naïve to the relevant vaccine HPV type(s)
Resultater for relevante effektmål analyseret 2 år efter rekruttering og ved undersøgelsens afslutning (middelvarighed for opfølgning = 3, 6 år) i per- protokolpopulationen er gengivet i tabel 1.
The efficacy results for relevant endpoints analysed at 2 years post-enrolment and at end of study (median duration of follow-up = 3.6 years) in the per-protocol population are presented in the Table 1.
I en supplerende analyse blev Gardasils effekt mod HPV 16/ 18- relateret CIN 3 og AIS evalueret.
Table 1:
Analyse af Gardasils effekt imod high- grade cervixlæsioner i PPE- populationen
Analysis of efficacy of Gardasil against high grade cervical lesions in the PPE population
% Effekt ***
Number Number
Antal
% Number
Antal% Effekt
of cases of cases
Antal
Efficacy of cases
ved
of cases
tilfælde
at end of
tilfælde
Number Number
tilfælde
at 2 years Number
tilfælde
Number Number at 2 years Number Number
ved 2 år
study
Antal Antal
of of
(95% CI) Antal
(95% CI) of
Antal Antal (95% CI) Antal Antal
of of (95% CI) of of
personer * personer *
subjects* subjects*
personer *
subjects* subjects*
HPV 16/ 18- relateret
HPV 16/ 18-related
CIN 2/ 3 eller AIS
CIN 2/ 3 or AIS
HPV 16/ 18- relateret CIN 3
HPV 16/ 18-related CIN 3
HPV 16/ 18- relateret AIS
HPV 16/ 18-related
0 8487
8487
6 8460
8460
100 (14, 8, 100, 0)
(14.8, 100.0)
0 8493
8493
7 8464
8464
100 (30, 6, 100, 0)
(30.6, 100.0)
* Antal forsøgspersoner med mindst et opfølgningsbesøg efter måned 7 ** Baseret på virologiske vidnesbyrd er dette tilfælde af CIN 3 hos en patient, der er kronisk inficeret med HPV 52, sandsynligvis kausalt relateret til HPV 52.
*Number of subjects with at least one follow-up visit after Month 7 **Based on virologic evidence, this CIN 3 case in a patient chronically infected with HPV 52 is likely to be causally related to HPV 52.
HPV 16 blev kun fundet i 1 af 11 prøver (ved måned 32, 5) og blev ikke påvist i væv, der blev udtaget under LEEP (Loop Electro- Excision Procedure).
In only 1 of 11 specimens HPV 16 was found (at Month 32.5) and was not detected in tissue excised during LEEP (Loop Electro-Excision Procedure).
Bemærk:
In the second CIN 3 case observed in a patient infected with HPV 51 at Day 1 (in 2 of 9 specimens); HPV 16 was detected at a Month 51 biopsy (in 1 of 9 specimens) and HPV 56 was detected in 3 of 9 specimens at Month 52 in tissue excised during LEEP. ***Patients were followed for up to 4 years (median 3.6 years) Note:
Punktestimater og konfidensintervaller er justeret for person- opfølgningstidspunkt.
Point estimates and confidence intervals are adjusted for person-time of follow-up.
Ved afslutning af undersøgelsen og i de kombinerede protokoller var:
At end of study and in the combined protocols,
91, 4, 98, 4)
the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9% (95% CI:
Effekten af Gardasil imod HPV 6 -, 11 -, 16 -, 18- relateret CIN (1, 2, 3) eller AIS var 96, 0% (95% CI:
91.4, 98.4) the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0% (95% CI:
92, 3, 98, 2)
92.3, 98.2)
7 Effekten af Gardasil imod HPV 6 -, 11 -, 16 -, 18- relateret VIN2/ 3 og VaIN 2/ 3 var henholdsvis 100% (95% CI:
the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related VIN2/ 3 and VaIN 2/ 3 was 100% (95% CI:
67, 2, 100) og 100% (95% CI:
67.2, 100) and 100% (95% CI:
55, 4, 100)
55.4, 100) respectively
Effekten af Gardasil imod HPV 6 -, 11 -, 16 -, 18- relaterede kønsvorter var 99, 0% (95% CI:
7 the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
I protokol 012 var effekten af Gardasil med udgangspunkt i 6- måneders definitionen af persisterende infektion [prøver positive ved 2 eller flere følgende besøg efter hinanden med et interval på 6 måneder (±1 måned) eller længere] henholdsvis 98, 7% (95% CI:
In Protocol 012 the efficacy of Gardasil against the 6 month definition of persistent infection [samples positive on two or more consecutive visits 6 months apart (±1 month) or longer] related to HPV 16 was 98.7% (95% CI:
95, 1; 99, 8) for så vidt angår HPV 16, og 100, 0% (95% CI:
95.1, 99.8) and 100.0% (95% CI:
93, 2; 100, 0) for HPV 18 efter en opfølgning på op til 4 år (middelværdi på 3, 6 år).
93.2, 100.0) for HPV 18 respectively, after a follow-up of up to 4 years (mean of 3.6 years).
For så vidt angår 12- måneders definitionen af persisterende infektion, var effekten henholdsvis 100, 0% (95% CI:
For the 12 month definition of persistent infection, efficacy against HPV 16 was 100.0% (95% CI:
93, 9; 100, 0) for HPV 16, og 100, 0% (95% CI:
93.9, 100.0) and 100.0% (95% CI:
79, 9; 100, 0) for HPV 18.
79.9, 100.0) for HPV 18 respectively.
Effekt hos personer med tegn på HPV 6 -, 11 -, 16 - eller 18- infektion eller sygdom ved dag 1
Efficacy in individuals with evidence of HPV 6, 11, 16, or 18 infection or disease at day 1
Der var ingen evidens for beskyttelse imod sygdom forårsaget af vaccine- HPV- typer, overfor hvilke forsøgspersonerne var PCR- positive ved dag 1.
There was no evidence of protection from disease caused by vaccine HPV types for which subjects were PCR positive at day 1.
Personer, som allerede var inficeret med en eller flere vaccine- relaterede HPV- typer forud for vaccination, var beskyttet imod klinisk sygdom forårsaget af de resterende vaccine- HPV- typer.
Individuals who were already infected with one or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV types.
Effekt hos personer med eller uden forudgående infektion eller sygdom grundet HPV 6, 11, 16 eller 18
Efficacy in subjects with and without prior infection or disease due to HPV 6, 11, 16, or 18
Kvinderne fik mindst en vaccination og for hvem registrering af sygdomstilfælde påbegyndtes 1 måned efter indgift af første dosis.
The modified intention to treat (ITT) population included women regardless of baseline HPV status at Day 1, who received at least one vaccination and in whom case counting started at 1 month Postdose 1.
Denne population ligger tæt op ad den generelle kvindelige befolkning, for så vidt angår forekomst af HPV- infektion eller - sygdom ved rekruttering.
This population approximates to the general population of women with respect to prevalence of HPV infection or disease at enrolment.
Resultaterne er opsummeret i tabel 2.
The results are summarised in Table 2.
Effekt af Gardasil imod high- grade cervixlæsioner i den modificerede ITT- population, der inkluderer kvinder uanset baseline HPV- status
Efficacy of Gardasil in high grade cervical lesions in the modified ITT-population including women regardless of baseline HPV status
% Effekt **
%
Antal
Number of Number
Antal
Efficacy**
ved
cases
Effekt **
of cases
tilfælde tilfælde
Efficacy** of cases
tilfælde tilfælde Ved 2 år
of cases
undersøgelsens
at end of
Antal forsøgs -
Number of Number
Antal
at 2 years Num
Antal Antal (95% CI)
Number of Number at 2 years Number Number
afslutning
study
personer *
subjects*
forsøgs -
of
forsøgs - forsøgs -
(95% CI) of of
(95% CI)
of (95% CI) of of
personer *
(95% CI)
HPV 16 - eller
HPV 16- or HPV
HPV 18- relateret CIN 2/ 3 eller AIS
18-related CIN 2/ 3 or AIS
HPV 16/ 18 - relateret CIN 3 HPV 16/ 18 - relateret AIS
HPV 16/ 18- related CIN 3
46, 0 (31, 0, 57, 9) 60, 0 (< 0, 87, 3)
46.0 (31.0, 57.9)
* Antal forsøgspersoner med mindst et opfølgningsbesøg efter 30 dage efter dag 1 ** Procentdel effekt beregnes ud fra de kombinerede protokoller.
*Number of subjects with at least one follow-up visit after 30 days after Day 1 **Percent efficacy is calculated from the combined protocols.
Effekten over for HPV 16/ 18- relateret CIN 2/ 3 eller AIS er baseret på data fra protokollerne 005 (kun 16- relaterede effektmål), 007, 013 og 015.
The efficacy for HPV 16/ 18 related CIN 2/ 3 or AIS is based on data from protocols 005 (16-related endpoints only), 007, 013, and 015.
Patienterne blev fulgt i op til 4 år (middelvarighed 3, 6 år).
Patients were followed for up to 4 years (median 3.6 years).
Punktestimater og konfidensintervaller er justeret for person- opfølgningstidspunkt.
Note: point estimates and confidence intervals are adjusted for person-time of follow-up.
Effekt imod HPV 6 -, 11 -, 16 -, 18- relateret VIN 2/ 3 var 73, 3% (95% CI:
Efficacy against HPV 6-, 11-, 16-, 18-related VIN 2/ 3 was 73.3% (95% CI:
40, 3, 89, 4), imod HPV 6 -, 11 -, 16 -, 18- relateret VaIN 2/ 3 var den 85, 7% (95% CI:
40.3, 89.4), against HPV 6-, 11-, 16-, 18-related VaIN 2/ 3 was 85.7% (95% CI:
37, 6, 98, 4) og imod HPV 6 -, 11 -, 16 -, 18 - relaterede kønsvorter 80, 3% (95% CI:
37.6, 98.4), and against HPV 6-, 11-, 16-, 18- related genital warts was 80.3% (95% CI:
73, 9, 85, 3) i de kombinerede protokoller ved undersøgelsens afslutning.
73.9, 85.3) in the combined protocols at end of study.
Sammenlagt havde 12% af den kombinerede undersøgelsespopulation en abnorm Pap- test, hvilket antydede tilstedeværelse af CIN ved dag 1.
Overall 12% of the combined study population had an abnormal Pap test suggestive of CIN at Day 1.
Blandt de forsøgspersoner med en abnorm Pap- test ved dag 1, som var naive over for de relevante vaccine- HPV- typer ved dag 1, forblev vaccinens effekt høj.
Among subjects with an abnormal Pap test at Day 1 who were naïve to the relevant vaccine HPV types at Day 1, efficacy of the vaccine remained high.
8 Blandt de forsøgspersoner, som havde en abnorm Pap- test ved dag 1, som allerede var inficeret med de relevante vaccine- HPV- typer ved dag 1, blev der ikke set nogen vaccineeffekt.
Among subjects with an abnormal Pap test at Day 1 who were already infected with the relevant vaccine HPV types at Day 1, no vaccine efficacy was observed.
Beskyttelse imod den generelle byrde af cervikal HPV- sygdom hos 16 til 26 år gamle kvinder
8 Protection Against the Overall Burden of Cervical HPV disease in 16- Through 26-Year-Old Women
Virkningen af Gardasil over for den generelle risiko for cervikal HPV- sygdom (dvs. sygdom forårsaget af enhver HPV- type) blev evalueret fra og med 30 dage efter den første dosis hos 17. 599 forsøgspersoner rekrutteret til de to fase III effektundersøgelser (protokollerne 013 og 015).
The impact of Gardasil against the overall risk for cervical, HPV disease (i. e., disease caused by any HPV type) was evaluated starting 30 days after the first dose in 17,599 subjects enrolled in the two phase III efficacy trials (Protocols 013 and 015).
Blandt forsøgspersoner, som var naive over for 14 almindelige HPV- typer og som havde en negativ Pap- test ved dag 1, reducerede indgivelsen af Gardasil incidensen af CIN 2/ 3 eller AIS forårsaget af vaccine - eller ikke- vaccine- HPV- typer med 42, 7% (95% CI:
Among subjects who were naïve to 14 common HPV types and had a negative Pap test at Day 1, administration of Gardasil reduced the incidence of CIN 2/ 3 or AIS caused by vaccine- or non-vaccine HPV types by 42.7% (95% CI:
23, 7, 57, 3) og for kønsvorter med 82, 8% (95% CI:
23.7, 57.3) and of genital warts by 82.8% (95% CI:
74, 3, 88, 8) ved undersøgelsens afslutning.
74.3, 88.8)at end of study.
Fordelen ved vaccinen for så vidt angår den generelle forekomst af CIN 2/ 3 eller AIS (forårsaget af enhver HPV- type) og kønsvorter var meget lavere i den modificerede ITT- population, med en reduktion på henholdsvis 18, 4% (95% CI:
In the modified ITT population, the benefit of the vaccine with respect to the overall incidence of CIN 2/ 3 or AIS (caused by any HPV type) and of genital warts was much lower, with a reduction of 18.4% (95% CI:
7, 0, 28, 4) og 62, 5% (95% CI:
7.0, 28.4) and 62.5% (95% CI:
54, 0, 69, 5), eftersom Gardasil ikke påvirker forløbet af infektioner eller sygdom, som er til stede på tidspunktet for vaccinationens påbegyndelse.
54.0, 69.5), respectively, as Gardasil does not impact the course of infections or disease that are present at vaccination onset.
Virkning på definitive cervix behandlingsprocedurer
Impact on Definitive Cervical Therapy Procedures
Gardasils virkning på hyppigheden af definitive cervix behandlingsprocedurer uanset udløsende HPV - typer blev evalueret hos 18. 150 forsøgspersoner rekrutteret til protokollerne 007, 013 og 015.
The impact of Gardasil on rates of Definitive Cervical Therapy Procedures regardless of causal HPV types was evaluated in 18,150 subjects enrolled in Protocol 007, Protocols 013 and 015.
I den HPV- naive population (naive overfor 14 almindelige HPV typer og med negativ Pap test ved dag 1) reducerede Gardasil andelen af kvinder, som blev underkastet en definitiv cervix behandlingsprocedure (Loop Electro- Excision Procedure eller koldknivs konisering) med 41, 9% (95% CI:
In the HPV naïve population (naïve to 14 common HPV types and had a negative Pap test at Day 1), Gardasil reduced the proportion of women who experienced, a definitive cervical therapy procedure (Loop Electro-Excision Procedure or Cold-Knife Conization) by 41.9% (95% CI:
27, 7, 53, 5) ved undersøgelsens afslutning.
27.7, 53.5) at end of study.
I ITT- populationen var den tilsvarende reduktion 23, 9% (95% CI:
In the ITT population the corresponding reduction was 23.9% (95% CI:
Gardasil’ s effekt over for CIN (af enhver grad) og CIN 2/ 3 eller AIS forårsaget af 10 ikke- vaccine - HPV- typer (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59), der er strukturelt relateret til HPV 16 eller HPV 18, blev evalueret i den kombinerede fase III effektdatabase (N = 17. 599) efter en middelopfølgningstid på 3, 7 år (ved undersøgelsens afslutning).
Cross-protective efficacy The efficacy of Gardasil against CIN (any grade) and CIN 2/ 3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Effekt over for sygdoms- endpoints forårsaget af forud specificerede kombinationer af ikke- vaccine- HPV- typer blev målt.
Efficacy against disease endpoints caused by pre-specified combinations of non-vaccine HPV types was measured.
Undersøgelserne var ikke gearet til at vurdere effekten over for sygdom forårsaget af individuelle HPV- typer.
The studies were not powered to assess efficacy against disease caused by individual HPV types.
Den primære analyse blev udført på type- specifikke populationer, hvor det var et krav, at kvinder var negative for den type, der blev analyseret for, men kunne være positive for andre HPV- typer (96% af den samlede population).
The primary analysis was done in type-specific populations that required women to be negative for the type being analyzed, but who could be positive for other HPV types (96% of the overall population).
Den primære tidspunktsanalyse efter 3 år nåede ikke statistisk signifikans for alle på forhånd specificerede endpoints.
The primary time point analysis after 3 years did not reach statistical significance for all pre-specified endpoints.
De endelige resultater ved undersøgelsens afslutning for den kombinerede incidens af CIN 2/ 3 eller AIS i denne population efter en middelopfølgningstid på 3, 7 år er vist i tabel 3.
The final end-of-study results for the combined incidence of CIN 2/ 3 or AIS in this population after a median follow-up of 3.7 years are shown in Table 3.
For de kombinerede endpoints blev der påvist en statistisk signifikant effekt over for sygdom over for HPV- typer, der phylogenetisk er relateret til HPV 16 (primært HPV 31), mens der ikke sås nogen statistisk signifikant effekt for så vidt angår HPV- typer, der phylogenetisk er relateret til HPV 18 (herunder HPV 45).
For composite endpoints, statistically significant efficacy against disease was demonstrated against HPV types phylogenetically related to HPV 16 (primarily HPV 31) whereas no statistically significant efficacy was observed for HPV types phylogenetically related to HPV 18 (including HPV 45).
For de 10 individuelle HPV- typer blev der kun nået statistisk signifikans for HPV 31.
For the 10 individual HPV types, statistical significance was only reached for HPV 31.
9 Tabel 3:
9 Table 3:
Resultater for CIN 2/ 3 eller AIS hos type- Specifikke HPV- naive forsøgspersoner † (resultater ved undersøgelsens afslutning) Naive over for ≥ 1 HPV- type
Results for CIN 2/ 3 or AIS in Type-Specific HPV-Naïve Subjects † (end of study results) Naïve to ≥ 1 HPV Type
Kombineret endpoint
Composite Endpoint
12, 1; 63, 9
12.1, 63.9
(HPV 31/ 33/ 45/ 52/ 58) § 10 ikke- vaccine- HPV- typer║ HPV- 16- relaterede typer (A9 arter)
(HPV 31/ 33/ 45/ 52/ 58) § 10 non-vaccine HPV Types ║
111 162 111
111
150 211 157
157
25, 8% 23, 0% 29, 1%
9.1, 44.9
4, 6; 42, 5 5, 1; 37, 7 9, 1; 44, 9
HPV HPV HPV HPV HPV
HPV 31 HPV 33 HPV 35 HPV 52 HPV 58 HPV- 18- relaterede typer (A7 arter)
31 33 35 52 58
26, 2; 74, 1 † < 0; 52, 1 † < 0; 61, 9 † < 0; 44, 2 † < 0; 61, 0 † < 0; 53, 9
26.2, 74.1† < 0, 52.1† < 0, 61.9 † < 0, 44.2† < 0, 61.0†
HPV 39 HPV 45 HPV 59 A5 arter (HPV 51) A6 arter (HPV 56) †
HPV-18 related types (A7 species)
< 0; 69, 5 † < 0; 60, 7 † < 0; 76, 8 † < 0; 48, 5 † < 0; 32, 5 †
< 0, 69.5† < 0, 60.7† < 0, 76.8†
Undersøgelserne var ikke gearet til at vurdere effekt over for sygdom forårsaget af individuelle HPV- typer. ‡ Effekt var baseret på reduktioner af HPV 31- relateret CIN 2/ 3 eller AIS § Effekt var baseret på reduktioner af HPV 31 -, 33 -, 52 - og 58- relateret CIN 2/ 3 eller AIS ║ Herunder analyse- identificerede ikke- vaccine- HPV- typer 31, 33, 35, 39, 45, 51, 52, 56, 58 og 59.
The studies were not powered to assess efficacy against disease caused by individual HPV types. ‡ Efficacy was based on reductions in HPV 31-related CIN 2/ 3 or AIS § Efficacy was based on reductions in HPV 31-, 33-, 52-, and 58-related CIN 2/ 3 or AIS ║ Includes assay-identified non-vaccine HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59.
For HPV- vacciner er der ikke blevet identificeret et minimalt antistofniveau, som er associeret med beskyttelse.
No minimum antibody level associated with protection has been identified for HPV vaccines.