natgillin/translations-raw huggingface dataset:
Det primære endpoint for effekt var CIN2+ associeret med HPV- 16 og/ eller HPV- 18.
The primary efficacy endpoint was CIN2+ associated with HPV-16 and/ or HPV-18.
De sekundære endpoint inkluderede 12- måneders persisterende infektion.
The secondary endpoints included 12-month persistent infection.
Cervikal intraepitelialneoplasi (CIN) grad 2 og 3 blev brugt i de kliniske forsøg som surrogatmarkør for cervix- cancer.
Cervical Intraepithelial Neoplasia (CIN) grade 2 and 3 was used in the clinical trials as a surrogate marker for cervical cancer.
4. 1 dækker moderate og svære cervikale celleforandringer (Cervical Intraepitelial Neoplasi (CIN) grad 2 og 3).
The term “ premalignant cervical lesions” in section 4.1 corresponds to high-grade Cervical Intraepithelial Neoplasia (CIN 2/ 3).
Forebyggende effekt mod HPV- 16/ 18- infektion i en population, som var naive for onkogene HPV - typer
Prophylactic efficacy against HPV-16/ 18 infection in a population naïve to oncogenic HPV types
I forsøg 001 blev kvinder (N = 1113) vaccineret og effekten undersøgt i op til måned 27.
Women (N=1,113) were vaccinated in study 001 and evaluated for efficacy up to month 27.
77 måneder) efter første dosis (middelopfølgning på 5, 9 år).
A subset of women (N=776) vaccinated in study 001 was followed in study 007 up to 6.4 years (approximately 77 months) after the first dose (mean follow-up of 5.9 years).
I forsøg 001 var der 5 tilfælde af 12 - måneders persisterende HPV- 16/ 18- infektion (4 HPV- 16; 1 HPV- 18) i kontrolgruppen og 1 tilfælde af HPV- 16 i vaccinegruppen.
There were five cases of 12-month persistent HPV-16/ 18 infection (4 HPV-16; 1 HPV-18) in the control group and one HPV-16 case in the vaccine group in study 001.
I forsøg 007 var effekten af Cervarix mod 12- måneders persisterende HPV- 16/ 18- infektion 100% (95% CI:
In study 007 the efficacy of Cervarix against 12-month persistent HPV-16/ 18 infection was 100% (95% CI:
80, 5- 100).
80.5; 100).
Der var 16 tilfælde af persisterende HPV- 16 - infektioner og 5 tilfælde af persisterende HPV- 18- infektioner, alle i kontrolgruppen.
There were sixteen cases of persistent HPV-16 infection, and five cases of persistent HPV-18 infection, all in the control group.
Forebyggende effekt hos kvinder, naive for HPV- 16 og/ eller HPV- 18.
Prophylactic efficacy in women naïve to HPV-16 and/ or HPV-18
I forsøg 008 blev de primære analyser af effekten udført på hele den vaccinerede kohorte (TVC- 1).
In study 008 the primary analyses of efficacy were conducted in the total vaccinated cohort (TVC-1).
Denne kohorte inkluderede kun kvinder, som var HPV DNA- negative og seronegative over for de relevante HPV- typer (HPV- 16 eller HPV- 18) ved inklusionen, og som havde fået mindst 1 dosis Cervarix eller kontrolvaccinen.
This cohort included only women who were HPV DNA negative and seronegative to the relevant HPV type (HPV-16 or HPV-18) at study entry and had received at least one dose of Cervarix or the control.
Kvinder med svære celleforandringer eller manglende cytologi (0, 5%) blev ekskluderet fra effektanalyserne.
Women with high-grade or missing cytology (0.5%) were excluded from the efficacy analysis.
I alt var 74, 0% af kvinderne ved inklusionen naive for både HPV- 16 og HPV- 18.
Overall, 74.0% of women enrolled were naïve to both HPV-16 and HPV-18 at study entry.
Effekten af Cervarix til forebyggelse af CIN2+ associeret med HPV- 16 og/ eller HPV- 18, undersøgt i op til 15 måneder efter sidste dosis af vaccine eller kontrol, og hyppigheden af 12- måneders persisterende infektion i TVC- 1- kohorten er angivet i tabellen nedenfor.
The efficacy of Cervarix in the prevention of CIN2+ associated with HPV-16 and/ or HPV-18 as assessed up to 15 months after the last dose of vaccine or control and the rates of 12-month persistent infection in the TVC-1 cohort are presented in the table below:
6 Forsøg 008
Study 008
(97, 9% CI) CIN2+ (primært endpoint)
(97.9% CI) CIN2+ (primary endpoint)
HPV- 16 og/ eller 18 * HPV- 16
HPV-16 and/ or 18* HPV-16
90, 4 (53, 4- 99, 3) 93, 3 (47, 0- 99, 9)
90.4 (53.4; 99.3) 93.3 (47.0; 99.9)
83, 3 (< 0, 0- 99, 9)
83.3 (< 0.0; 99.9)
12- måneders persisterende infektion (sekundære endpoint) HPV- 16 og/ eller 18 * HPV- 16 HPV- 18
12-month persistent infection (secondary endpoint) HPV-16 and/ or 18* HPV-16 HPV-18
75, 9 (47, 7- 90, 2) 79, 9 (48, 3- 93, 8) 66, 2 (< 0, 0- 94, 0)
75.9 (47.7; 90.2) 79.9 (48.3; 93.8) 66.2 (< 0.0; 94.0)
N = antal personer inkluderet i hver gruppe i TVC- 1- kohorten n = antal tilfælde * protokol- specificeret endpoint
N = number of subjects included in each group of TVC-1 cohort n = number of cases *protocol-specified endpoints
Alle endpoint har opnået statistisk signifikans for HPV- 16.
All endpoints reached statistical significance for HPV-16.
For HPV- 18 var forskellen mellem vaccine - og kontrolgruppen ikke statistisk signifikant for CIN2+ og 12- måneders persisterende infektion (TVC- 1 kohorte).
For HPV-18, the difference between the vaccine and control groups was not statistically significant for CIN2+ and 12 month persistent infection (TVC-1 cohort).
Der blev foretaget en præ- specificeret analyse (TVC- 2), som var identisk med TVC- 1- analysen, bortset fra at kvinder med abnorm cytologi ved studiets start ikke blev medtaget.
However, in a pre-specified analysis (TVC-2) that was identical to the
Her var endpoint (12- månders persisterende infektion for HPV- 18) statistisk signifikant med en vaccineeffekt på 89, 9% (97, 9% CI; 11, 3- 99, 9).
6 TVC-1 analysis except that it excluded women with abnormal cytology at study entry, the 12 month persistent infection endpoint for HPV-18 reached statistical significance with vaccine efficacy of 89.9% (97.9% CI:
Et tilfælde blev observeret i vaccinegruppen, mens der blev set 10 tilfælde i kontrolgruppen.
One case was observed in the vaccine group versus 10 cases in the control group.
Flere CIN2+ celleforandringer indeholdt flere onkogene typer (inklusive ikke- vaccine HPV- typer).
Several of the CIN2+ lesions contained multiple oncogenic types (including non-vaccine HPV types).
En supplerende analyse blev udført for at fastslå effekten af vaccine over for celleforandringer, som sandsynligvis var kausalt associeret med HPV- 16 og/ eller HPV- 18.
An additional analysis was conducted to determine vaccine efficacy against lesions likely to be causally associated with HPV-16 and/ or HPV-18.
På basis af tilstedeværelsen af HPV- typen i de cytologiske prøver, taget umiddelbart før påvisning af celleforandring, viser denne post- hoc analyse (klinisk tillægsanalyse) en kausal sammenhæng mellem en HPV- type og celleforandringen.
This post-hoc analysis (clinical case assignment) assigned causal association of an HPV type with the lesion based on the presence of the HPV type in cytology samples prior to detection of the lesion.
På basis af denne tillægsanalyse, ekskluderedes 3 CIN2+ tilfælde (2 i vaccinegruppen og 1 i kontrolgruppen), hvor det blev vurderet, at der ikke var kausal sammenhæng med HPV- 16 eller HPV- 18- infektioner, opstået under forsøget.
Based on this case assignment, the analysis excluded 3 CIN2+ cases (2 in the vaccine group and 1 in the control group) which were not considered to be causally associated with HPV-16 or HPV-18 infections acquired during the trial.
På basis af denne analyse var der ingen hændelser i vaccinegruppen og 20 hændelser i kontrolgruppen (effekt 100%; 97, 9% CI; 74, 2 - 100).
74.2; 100).
Forebyggende effekt hos kvinder med eksisterende eller tidligere infektion.
Prophylactic efficacy in women with current or prior infection
Der var ikke evidens for beskyttelse mod sygdom forårsaget af de HPV- typer, som personer var HPV DNA- positive over for ved inklusionen.
There was no evidence of protection from disease caused by the HPV types for which subjects were HPV DNA positive at study entry.
Dog blev de personer, som forud for vaccination allerede havde en infektion med en vaccinerelateret HPV- type, beskyttet mod kliniske sygdomme forårsaget af de øvrige HPV- typer.
However, individuals already infected with one of the vaccine- related HPV types prior to vaccination were protected from clinical disease caused by the remaining HPV type.
26% af kvinderne evidens for, at de havde eller tidligere havde haft en infektion.
In study 008, approximately 26% of women had evidence of current and/ or prior infection.
Tyve procent af kvinderne havde haft en tidligere infektion (dvs.
Twenty percent of women had evidence of prior infection (i. e.
HPV- 16 og/ eller HPV- 18 seropositive).
HPV-16 and/ or HPV-18 seropositive).
Syv procent af kvinderne var inficeret på vaccinationstidspunktet (dvs.
Seven percent of women were infected at time of vaccination (i. e.
HPV- 16 og/ eller HPV- 18 DNA- positive) af hvilke kun 0, 5% var DNA positive for begge typer.
HPV-16 and/ or HPV-18 DNA positive) of which only 0.5% were DNA positive for both types.
Der er ikke for HPV- vacciner fastsat en minimumgrænse for antistofniveauet associeret med beskyttelse mod CIN grad 2 eller 3, eller persisterende infektion med vaccinerelaterede HPV- typer.
No minimal antibody level associated with protection against CIN of grade 2 or 3 or against persistent infection associated with vaccine HPV types has been identified for HPV vaccines.
Antistofrespons mod HPV- 16 og HPV- 18 blev målt ved hjælp af en type- specifik ELISA, som viste korrelation til pseudovirion- baseret neutraliseringsbestemmelse.
The antibody response to HPV-16 and HPV-18 was measured using a type-specific ELISA which was shown to correlate with the pseudovirion-based neutralisation assay.
Immunogeniciteten induceret efter 3 doser af Cervarix er vurderet hos 5303 kvinder i alderen fra 10 til 55 år.
The immunogenicity induced by three doses of Cervarix has been evaluated in 5,303 female subjects from 10 to 55 years of age.
7 I kliniske forsøg havde 99, 9% af initialt seronegative personer serokonverteret for både HPV type 16 og 18 1 måned efter 3. dosis.
In clinical trials, 99.9% of initially seronegative subjects had seroconverted to both HPV types 16 and 18 one month after the third dose.
Vaccine- induceret IgG geometrisk middeltiter (GMT) var markant højere end titerne observeret hos kvinder, som selv havde bekæmpet en tidligere HPV- infektion (naturlig infektion).
Vaccine-induced IgG Geometric Mean Titres (GMT) were well above titres observed in women previously infected but who cleared HPV infection (natural infection).
I forsøg 001/ 007, som inkluderede kvinder i alderen fra 15 til 25 år på vaccinationstidspunktet, blev immunresponset vurderet over for HPV- 16 og HPV- 18 i op til 76 måneder efter 1. dosis.
Study 001/ 007, which included women from 15 to 25 years of age at the time of vaccination, evaluated the immune response against HPV-16 and HPV-18 up to 76 months post dose 1.
Vaccine- induceret IgG geometrisk middeltiter (GMT) for både HPV- 16 og HPV- 18 var højest efter måned 7, hvorefter det faldt til et plateau fra måned 18 til slutningen af opfølgningen (måned 76).
Vaccine-induced IgG Geometric Mean Titres (GMT) for both HPV-16 and HPV-18 peaked at month 7 and then declined to reach a plateau from month 18 up to the end of the follow-up (month 76).
Ved slutningen af opfølgningsperioden var GMT for både HPV- 16 og HPV- 18 stadig mindst 11 gange højere end titerene observeret hos de kvinder, som selv havde bekæmpet en tidligere HPV- infektion, og > 98% af kvinderne var stadig seropositive over for begge antigener.
At the end of the follow-up period, GMTs for both HPV-16 and HPV-18 were still at least 11-fold higher than titres observed in women previously infected but who cleared HPV infection and > 98% of the women were still seropositive for both antigens.
I forsøg 008 var immunogeniciteten ved måned 7 i overensstemmelse med responset observeret i forsøg 001.
In study 008, immunogenicity at month 7 was similar to the response observed in study 001.
I et andet klinisk forsøg (forsøg 014) med kvinder i alderen fra 15 til 55 år, serokonverterede alle personer for både HPV type 16 og 18 efter 3. dosis (ved måned 7).
In another clinical trial (study 014) performed in women aged 15 to 55 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7).
Sammenkobling af effekten af Cervarix hos yngre voksne kvinder og piger.
7 Bridging the efficacy of Cervarix from young adult women to adolescents
I to kliniske forsøg med piger og unge i alderen fra 10 til 14 år serokonverterede alle personer for både HPV- type 16 og 18 efter den 3. dosis (ved måned 7), og GMT var mindst 2 gange højere i forhold til kvinder i alderen fra 15 til 25 år.
In two clinical trials performed in girls and adolescents aged 10 to 14 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7) with GMTs at least 2-fold higher as compared to women aged 15 to 25 years.
På basis af disse immunogenicitetsdata konkluderes det, at Cervarix har effekt hos aldersgruppen fra 10 til 14 år.
On the basis of these immunogenicity data, the efficacy of Cervarix is inferred from 10 to 14 years of age.
Det er ikke nødvendigt med vurdering af de farmakokinetiske egenskaber for vacciner.
Evaluation of pharmacokinetic properties is not required for vaccines.
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter akut og gentagne doser, lokal tolerance, fertilitet, samt for embryo - / foster - og postnatal- toksicitet (til og med afslutningen af ammeperioden).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, fertility, embryo-foetal and postnatal toxicity (up to the end of the lactation period).
Sorologiske data fra rotter tyder på, at anti- HPV- 16 og anti- HPV- 18 antistoffer overføres via modermælk i ammeperioden.
Serological data suggest a transfer of anti-HPV-16 and anti-HPV-18 antibodies via the milk during the lactation period in rats.
Natriumchlorid (NaCl) Natriumdihydrogenphosphat dihydrat (NaH2PO4 2 H2O) Vand til injektionsvæsker
Sodium chloride (NaCl) Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) Water for injections
2
For adjuvants, see section 2.
0, 5 ml suspension i hætteglas (type I- glas) med prop til 1 dosis og (butylgummi) i pakningsstørrelser på 1, 10 og 100.
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in pack sizes of 1, 10 and 100.
Der kan forekomme et fint hvidt bundfald med et klart, farveløst væskelag på overfladen ved opbevaring af hætteglasset.
8 A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial.
Indholdet af hætteglasset skal forud for administration inspiceres visuelt både før og efter omrystningen for fremmede partikler og/ eller ændringer i det fysiske udseende.
The content of the vial should be inspected visually both before and after shaking for any foreign particulate matter and/ or abnormal physical appearance prior to administration.
Ikke anvendte vaccine samt affald herfra, bør bortskaffes i overensstemmelse med lokale retningslinjer.
Any unused product or waste material should be disposed of in accordance with local requirements.
Rue de l’ Institut 89 B1330 Rixensart, Belgien
Rue de l'Institut 89 B-1330 Rixensart, Belgium
20. september 2007
20 September 2007.
Vaccine mod human papillomvirus [type 16, 18] (rekombinant, adjuveret, adsorberet).
Cervarix suspension for injection, multidose Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Human papillomvirus1 type 16 L1- protein2, 3, 4 Human papillomvirus1 type 18 L1- protein2, 3, 4 1 Human papillomvirus = HPV 2 adjuveret med AS04 indeholdende:
Human Papillomavirus1 type 16 L1 protein2,3,4 Human Papillomavirus1 type 18 L1 protein2,3,4 1 Human Papillomavirus = HPV 2 adjuvanted by AS04 containing:
L1 protein i form af ikke- smitsom viruslignende partikel (VLP) produceret ved hjælp af rekombinant DNA- teknologi med brug af et Baculovirus- system, som anvender Hi- 5- Rix4446- celler fra Trichoplusia ni.
L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni.
6. 5 for antal doser pr. hætteglas.
See section 6.5 for the number of doses per vial.
Indikationen er baseret på påvisningen af effekt hos kvinder i alderen fra 15 til 25 år efter vaccination med Cervarix og på påvisning af vaccinens immunogenicitet hos piger og kvinder i alderen fra 10 til 25 år.
The indication is based on the demonstration of efficacy in women aged 15-25 years following vaccination with Cervarix and on the immunogenicity of the vaccine in girls and women aged 10-25 years.
11 4. 2 Dosering og indgivelsesmåde
4.2 Posology and method of administration
5. 1).
10 The need for a booster dose has not been established (see section 5.1).
4. 4).
It is recommended that subjects who receive a first dose of Cervarix complete the 3-dose vaccination course with Cervarix (see section 4.4).
12 Der findes ingen sikkerheds -, immunogenicitets - eller effektdata, der støtter udskiftning af Cervarix med andre HPV- vacciner i løbet af et vaccinationsprogram.
There are no safety, immunogenicity or efficacy data to support interchangeability of Cervarix with other HPV vaccines.
I samtlige kliniske undersøgelser blev personer, som havde modtaget immunoglubulin eller blodprodukter i 3 måneder forud for den første vaccinedosis, udelukket.
11 In all clinical trials individuals who had received immunoglobulin or blood products within 3 months prior to the first vaccine dose were excluded.
13 Bivirkninger, som ansås for at have en mulig sammenhæng med vaccinationen, er kategoriseret ud fra hyppighed.
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
Hyppigheden er rapporteret som:
12 Frequencies are reported as:
Meget almindelig (≥ 1/ 10) Almindelig (≥ 1/ 100 til < 1/ 10) Ikke almindelig (≥ 1/ 1000 til < 1/ 100)
Very common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100)
14 Kliniske forsøg
Clinical studies
Fase II- forsøget (forsøg 001/ 007) inkluderede kun kvinder, som:
The phase II trial (study 001/ 007) enrolled only women who:
15 Forsøg 008
Study 008
(97, 9% CI) CIN2+ (primært endpoint)
CIN2+ (primary endpoint)
12- måneders persisterende infektion (sekundære endpoint) HPV- 16 og/ eller 18 * HPV- 16 HPV- 18
12-month persistent infection (secondary endpoint)
3386 11 3437 2945 7 3143 4
HPV-16 and/ or 18* HPV-16 HPV-18
Alle endpoint har opnået statistisk signifikans for HPV- 16.
14 All endpoints reached statistical significance for HPV-16.
Her var endpoint (12- månders persisterende infektion for HPV- 18) statistisk signifikant med en vaccineeffekt på 89, 9% (97, 9% CI; 11, 3- 99, 9).
However, in a pre-specified analysis (TVC-2) that was identical to the TVC-1 analysis except that it excluded women with abnormal cytology at study entry, the 12 month persistent infection endpoint for HPV-18 reached statistical significance with vaccine efficacy of 89.9% (97.9% CI:
16 I kliniske forsøg havde 99, 9% af initialt seronegative personer serokonverteret for både HPV type 16 og 18 1 måned efter 3. dosis.
In clinical trials, 99.9% of initially seronegative subjects had seroconverted to both HPV types 16 and 18 one month after the third dose.
I et andet klinisk forsøg (forsøg 014) med kvinder i alderen fra 15 til 55 år, serokonverterede alle personer for både HPV type 16 og 18 efter 3. dosis (ved måned 7).
The GMTs were,
GMT var imidlertid lavere hos kvinder over 25 år.
15 however, lower in women above 25 years.
Sammenkobling af effekten af Cervarix hos yngre voksne kvinder og piger.
Bridging the efficacy of Cervarix from young adult women to adolescents
17 6. 2 Uforligeligheder
6.2 Incompatibilities
Hvis den ikke anvendes straks, skal vaccinen opbevares i køleskab (2 °C – 8 °C).
If not used immediately, the vaccine should be stored in a refrigerator (2°C – 8°C).
6. 3.
For storage after first opening, see section 6.3.
1 ml suspension i hætteglas (type I- glas) til 2 doser og med en prop (butylgummi) i pakningsstørrelser på 1, 10 og 100.
16 1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl) in pack sizes of 1, 10 and 100.
Når en flerdosisbeholder anvendes, skal hver dosis (0, 5 ml) udtages med en steril kanyle og injektionssprøjte; der skal tages forholdsregler for at undgå kontaminering.
When using a multidose vial, each 0.5 ml dose should be withdrawn using a sterile needle and syringe; precautions should be taken to avoid contamination of the contents.
Human papillomvirusvaccine [type 16, 18] (rekombinant, adjuveret, adsorberet).
Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix er en vaccine til forebyggelse af premaligne cervikale celleforandringer (Cervical Intraepitelial Neoplasi (CIN) grad 2 og 3) og cervix- cancer, der er kausalt relateret til humant papillomvirus (HPV) af typerne 16 og 18.
Cervarix is a vaccine for the prevention of premalignant cervical lesions and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18 (see section 5.1).
5. 1 for information om evidens for effekten af Cervarix til forbyggelse af premaligne cervikale celleforandringer associeret med HPV- 16 og/ eller HPV- 18.
See section 5.1 for information on the evidence that supports the efficacy of Cervarix in prevention of premalignant cervical lesions associated with HPV-16 and/ or HPV-18.
4. 4).
18 It is recommended that subjects who receive a first dose of Cervarix complete the 3-dose vaccination course with Cervarix (see section 4.4).
21 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
Anvendelse sammen med andre vacciner
19 Use with other vaccines
22 Hyppigheden er rapporteret som:
Frequencies are reported as:
Meget almindelig (≥ 1/ 10) Almindelig (≥ 1/ 100 til < 1/ 10) Ikke almindelig (≥ 1/ 1000 til < 1/ 100)
20 Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100)
Meget almindelige: reaktioner på administrationsstedet, herunder smerte, rødme og hævelse, samt træthed Almindelig: feber (≥38°C) Ikke almindelige: andre reaktioner på administrationsstedet såsom induration, lokal paræstesi
Very common: injection site reactions including pain, redness, swelling; fatigue Common: fever (≥ 38°C) Uncommon: other injection site reactions such as induration, local paraesthesia
23 Fase II- forsøget (forsøg 001/ 007) inkluderede kun kvinder, som:
The phase II trial (study 001/ 007) enrolled only women who:
I forsøg 007 var effekten af Cervarix mod 12- måneders persisterende HPV- 16/ 18- infektion 100% (95% CI; 80, 5- 100).
80.5; 100).
24 Forsøg 008
Study 008
Her var endpoint (12- månders persisterende infektion for HPV- 18) statistisk signifikant med en vaccineeffekt på 89, 9% (97, 9% CI; 11, 3- 99, 9).
22 TVC-1 analysis except that it excluded women with abnormal cytology at study entry, the 12 month persistent infection endpoint for HPV-18 reached statistical significance with vaccine efficacy of 89.9% (97.9% CI:
På basis af denne analyse var der ingen hændelser i vaccinegruppen og 20 hændelser i kontrolgruppen (effekt 100%; 97, 9% CI; 74, 2 - 100),
74.2; 100).
25 I kliniske forsøg havde 99, 9% af initialt seronegative personer serokonverteret for både HPV type 16 og 18 1 måned efter 3. dosis.
In clinical trials, 99.9% of initially seronegative subjects had seroconverted to both HPV types 16 and 18 one month after the third dose.
I forsøg 001/ 007, som inkluderede kvinder i alderen fra 15 til 25 år på vaccinationstidspunktet, blev immunresponset vurderet over for HPV- 16 og HPV- 18 i op til 64 måneder efter 1. dosis.
Study 001/ 007, which included women from 15 to 25 years of age at the time of vaccination, evaluated the immune response against HPV-16 and HPV-18 up to 76 months post dose 1.