FrancophonIA/ELRC3.0 huggingface dataset:
English: ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine as separate injections and at different body sites (see section 5.1).
Danish: ZOSTAVAX kan indgives parallelt med inaktiveret influenzavaccine som separate injektioner og på et andet sted på kroppen (se pkt.
English: Table 1: Adverse Reactions from Clinical Trial Experience and Post-Marketing Surveillance
Danish: Tabel 1: Bivirkninger rapporteret i kliniske studier og via overvågning efter markedsføring
English: However, post-marketing experience with varicella vaccines suggests that transmission of vaccine virus may occur rarely between vaccinees who develop a varicella-like rash and susceptible contacts [for example, varicella-zoster virus (VZV) susceptible infant grandchildren].
Danish: Erfaringer efter markedsføring af varicellavacciner viser dog, at spredning af vaccinevirus i sjældne tilfælde kan forekomme mellem vaccinerede, der udvikler et varicellalignende udslæt, og modtagelige kontaktindivider [f.eks. børnebørn (spædbørn) modtagelige for varicella-zoster-virus (VZV)].
English: The persistence of protection following vaccination has been evaluated through longer-term follow-up in Short-term Persistence Substudy (STPS) and Long-term Persistence Substudy (LTPS) and supports the continued benefit of ZOSTAVAX throughout the follow-up periods studied.
Danish: Varigheden af beskyttelsen efter vaccination er blevet undersøgt ved hjælp af langtidsopfølgning i de sekundære studier Short-term Persistence Substudy (STPS) og Long-term Persistence Substudy (LTPS), og resultaterne viste, at den gavnlige effekt af ZOSTAVAX varede ved i de undersøgte opfølgningsperioder.
English: † PHN was defined as zoster-associated pain rated as ≥3 (on a 0-10 scale), persisting or appearing more than 90 days after onset of zoster rash using Zoster Brief Pain Inventory (ZBPI).
Danish: † PHN blev defineret som zoster-relaterede smerter af sværhedsgraden ≥3 (på en skala fra 0-10), der fortsat var til stede, eller som debuterede, mere end 90 dage efter debut af zoster-udslættet (ved hjælp af Zoster Brief Pain Inventory (ZBPI)).
English: However, in-use stability has been demonstrated for 30 minutes when stored at 20 C - 25 C.
Danish: Vaccinens stabilitet ved brug er dog vist at være 30 minutter, når den opbevares ved 20 C - 25 C.
English: In the period from 90 days after rash onset to the end of follow-up, there was a 57% reduction in the severity-by-duration score (average scores of 347 for ZOSTAVAX and 805 for placebo; p=0.016).
Danish: I perioden fra 90 dage efter udslættets udbrud til afslutningen af followup var der en reduktion på 57 % i sværhedsgrad-efter-varighed-scoren (gennemsnitsscore 347 for ZOSTAVAX og 805 for placebo; p=0,016).
English: The solvent is a clear and colourless liquid.
Danish: Solvens er en klar og farveløs væske.
English: As with many vaccines, ZOSTAVAX may not completely protect all persons who are vaccinated.
Danish: Som med mange vacciner beskytter ZOSTAVAX muligvis ikke fuldstændigt alle personer, der vaccineres.
English: Patients who previously received immune suppressive therapy should be carefully evaluated for the reconstitution of the immune system prior to receiving Zostavax (see section 4.3).
Danish: Patienter, som tidligere har modtaget immunsuppressiv terapi, skal nøje evalueres for eventuel rekonstitution af immunsystemet før administration af Zostavax (se pkt.
English: Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Danish: Indehaver af markedsføringstilladelsen: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Frankrig
English: Transmission of vaccine virus from varicella vaccine recipients who do not develop a varicella-like rash has also been reported.
Danish: Spredning af vaccinevirus fra varicellavaccinerede, som ikke har udviklet varicellalignende udslæt, er også blevet rapporteret.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ZOSTAVAX in all the subsets of paediatric population (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ZOSTAVAX i alle undergrupper af den pædiatriske population (se pkt.
English: Common (≥1/100 to <1/10);
Danish: Almindelig (≥1/100 til <1/10);
English: Varicella, Herpes zoster (vaccine strain)
Danish: Varicella, herpes zoster (vaccinestamme)
English: However in a US effectiveness cohort study of 35,025 adults ≥ 60 years old, no increased risk of herpes zoster was observed in individuals who received ZOSTAVAX and 23-valent pneumococcal polysaccharide vaccine concomitantly (n=16,532) as compared to individuals receiving ZOSTAVAX one month to one year after 23-valent pneumococcal polysaccharide vaccine (n=18,493) in routine practice.
Danish: I et amerikansk kohortestudie af effektivitet med 35.025 voksne i alderen ≥ 60 år blev der imidlertid ikke observeret øget risiko for herpes zoster hos personer, der fik ZOSTAVAX og en 23-valent pneumokokpolysaccharidvaccine samtidigt (n=16.532), sammenlignet med personer, der fik ZOSTAVAX en måned til et år efter en 23-valent pneumokokpolysaccharidvaccine (n=18.493) i rutinemæssig praksis.
English: The VZV-specific immune responses following Doses 1 and 2 were similar (see section 4.3).
Danish: De VZV-specifikke immunresponser efter dosis 1 og 2 var sammenlignelige (se pkt.
English: • Very rare (may affect up to 1 in 10,000 people): Varicella (chicken pox); shingles; damage of retina caused by inflammation resulting in changes in sight (in patients under immunosuppressive therapy).
Danish: • Meget sjældne (kan forekomme hos op til 1 ud af 10.000 personer): skoldkopper (varicella), helvedesild og beskadigelse af retina forårsaget af inflammation med efterfølgende synsmæssige forandringer (hos patienter, som modtager immunsuppressiv terapi).
English: VZV-specific immune responses were generally similar in subjects 50 to 59 compared to subjects ≥60 years of age.
Danish: De VZVspecifikke immunresponser var generelt ens hos forsøgspersoner fra 50 til 59 år sammenlignet med forsøgspersoner ≥60 år.
English: Number of PHN cases
Danish: Antal PHNtilfælde
English: For precautions to be taken before handling or administering the medicinal product see section 6.6.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet, se pkt.
English: For instructions on reconstitution of the medicinal product before administration see section 6.6.
Danish: For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: Long-term effectiveness study in individuals 50 years of age or older In a large-scale ongoing US prospective observational cohort study of the long-term effectiveness of ZOSTAVAX, individuals 50 years of age or older at the time of vaccination are being followed for the occurrence of HZ and PHN using validated endpoints.
Danish: Langtidseffektivitetstudie hos personer på 50 år eller derover I et omfattende igangværende amerikansk prospektivt observationskohortestudie af langtidseffektiviteten af ZOSTAVAX følges personer, som var 50 år eller derover på vaccinationstidspunktet, for forekomst af HZ og PHN ved hjælp af validerede endepunkter.
English: No studies on the effects on the ability to drive or use machines have been performed.
Danish: Der er ikke foretaget studier af indflydelsen på evnen til at føre bil eller betjene maskiner.
English: The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Danish: Inden administrationen skal den rekonstituerede vaccine undersøges visuelt for fremmede partikler og/eller usædvanligt udseende.
English: The protective clinical efficacy of ZOSTAVAX was demonstrated in two large, randomised, placebo controlled clinical trials where subjects received ZOSTAVAX subcutaneously (see Tables 2 and 3).
Danish: Den beskyttende kliniske effekt af ZOSTAVAX blev påvist i to store randomiserede placebokontrollerede kliniske studier, hvor forsøgsdeltagerne fik ZOSTAVAX subkutant (se Tabel 2 og 3).
English: It may lead to severe and long-lasting pain and scarring.
Danish: Helvedesild kan medføre svære og langvarige smerter samt ardannelser.
English: ZOSTAVAX with solvent for reconstitution supplied in a pre-filled syringe: If two needles are provided, separate needles should be used for the reconstitution and administration of the vaccine.
Danish: ZOSTAVAX med solvens til rekonstitution leveret i forfyldt injektionssprøjte Hvis der medfølger 2 kanyler, bør der anvendes separate nåle til rekonstituering og indgivelse af vaccinen.
English: Your doctor will decide if ZOSTAVAX should be given.
Danish: Lægen vil afgøre, om De kan vaccineres med ZOSTAVAX.
English: Across all other clinical trials, the Oka/Merck strain was identified by PCR analysis from the lesion specimens of only two subjects who reported varicella-like rashes (onset on Day 8 and 17).
Danish: I alle andre kliniske studier taget under ét blev Oka/Merck-stammen kun påvist (ved hjælp af PCR-analyse) i prøver fra læsioner hos to forsøgspersoner, der rapporterede varicella-lignende udslæt (debut på Dag 8 og 17).
English: • if you are pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see
Danish: • hvis De er gravid (graviditet skal endvidere undgås 1 måned efter vaccination, se Graviditet og amning).
English: Over the 6-month (acute and chronic) follow-up period, there was a 22% reduction (p =0.008) in the severity-by-duration score and a 52% (95% CI: [7 to 74%]) reduction (from 6.2% to 3.5%) in the risk of having zoster with severe and long-lasting pain (severity-by-duration score of >600).
Danish: Inden for den 6 måneders (akutte og kroniske) followup-periode var der en 22 % reduktion (p =0,008) i sværhedsgradefter-varighed-scoren og en 52 % (95 % CI [7 til 74 %]) reduktion (fra 6,2 % til 3,5 %) i risikoen for at få zoster med svære og langvarige smerter (sværhedsgrad-efter-varighed-score på >600).
English: ZOSTAVAX powder for injection SC/IM
Danish: ZOSTAVAX pulver til injektionsvæske S.C./I.M.
English: What ZOSTAVAX contains
Danish: ZOSTAVAX indeholder
English: No subjects reported varicella-like or herpes zoster-like rashes.
Danish: Ingen forsøgspersoner rapporterede varicella-lignende eller herpes zoster-lignende udslæt.
English: It is recommended that the vaccine be administered immediately after reconstitution to minimise loss of potency.
Danish: Det anbefales, at vaccinen gives straks efter rekonstitution for ikke at miste styrke.
English: In SPS and ZEST, the number of subjects who reported herpes zoster/herpes zoster-like rashes was less than 0.2% for ZOSTAVAX and placebo groups, with no significant difference observed between the two groups.
Danish: I SPS og ZEST var antallet af forsøgspersoner, der rapporterede herpes zoster/herpes zoster-lignende udslæt, under 0,2 % i både ZOSTAVAX-gruppen og placebogruppen, og der var ingen signifikant forskel mellem de to grupper.
English: The majority of rashes have been rated as mild to moderate; no complications from rash have been observed in the clinical setting.
Danish: De fleste udslæt blev beskrevet som milde til moderate, og der blev ikke set kliniske komplikationer til udslættene.
English: In ZEST, the overall incidence of vaccine-related injection site adverse reactions were 63.9% for ZOSTAVAX and 14.4% for placebo in subjects 50 to 59 years of age.
Danish: I ZEST var den samlede incidens af vaccine-relaterede bivirkninger på injektionsstedet 63,9 % for ZOSTAVAX og 14,4 % for placebo hos forsøgspersoner i alderen 50 til 59 år.
English: In a clinical study, adults 60 years of age or older received a second dose of ZOSTAVAX 42 days following the initial dose (see section 5.1).
Danish: I et klinisk studie fik voksne på 60 år eller derover endnu en dosis ZOSTAVAX 42 dage efter den første dosis (se pkt.
English: Subjects with severe thrombocytopenia or any other coagulation disorder were excluded.
Danish: Patienter med svær trombocytopeni eller andre koagulationssygdomme blev ekskluderet.
English: In the event of either being observed, discard the vaccine.
Danish: Hvis noget af dette forekommer, skal vaccinen kasseres.
English: Shingles is caused by the same virus that causes chickenpox.
Danish: Helvedesild skyldes den samme virus, som forårsager skoldkopper.
English: Within ZEST, immune responses to vaccination were evaluated in a random 10% subcohort (n=1,136 for ZOSTAVAX and n=1,133 for placebo) of the subjects enrolled in the ZEST.
Danish: I ZEST blev immunresponset på vaccinationen evalueret i en vilkårlig underkohorte på 10% (n=1.136 for ZOSTAVAX og n=1.133 for placebo) af forsøgspersonerne i ZEST-studiet.
English: ZOSTAVAX should not be given to pregnant women.
Danish: ZOSTAVAX bør ikke gives til gravide.
English: In clinical trials with ZOSTAVAX, transmission of the vaccine virus has not been reported.
Danish: I kliniske studier af ZOSTAVAX blev der ikke rapporteret om spredning af vaccinevirus.
English: Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic/anaphylactoid reaction following the administration of the vaccine, as there is a possibility of hypersensitivity reactions, not only to the active substances, but also to the excipients and trace residuals (e.g. neomycin) present in the vaccine (see sections 4.3, 4.8 and 6.1).
Danish: Passende medicinsk behandling samt overvågning skal altid være lettilgængelig for de sjældne tilfælde af en anafylaktisk/anafylaktoid reaktion efter indgivelse af vaccinen, da der kan forekomme overfølsomhedsreaktioner, ikke blot over for de aktive stoffer, men også over for hjælpestoffer og reststoffer (f.eks. neomycin) i vaccinen (se pkt.
English: After reconstitution, the vaccine should be used immediately.
Danish: Vaccinen skal anvendes umiddelbart efter rekonstitution.
English: Prevention of HZ cases with severe pain in the entire SPS study population ZOSTAVAX reduced the incidence of zoster with severe and long-lasting pain (severity-by-duration score >600) by 73% (95% CI: [46 to 87%]) compared with placebo (11 vs. 40 cases, respectively).
Danish: Forebyggelse af HZ-tilfælde med svære smerter i den samlede SPS-studiepopulation ZOSTAVAX reducerede incidensen af herpes zoster med svære og langvarige smerter (sværhedsgradefter-varighed-score >600) med 73 % (95 % CI: [46-87 %]) sammenlignet med placebo (henholdsvis 11 versus 40 tilfælde).
English: § Age-adjusted estimate based on the age strata (60-69 and ≥70 years of age) at randomisation.
Danish: § Aldersjusteret estimat baseret på de aldersstrata (60-69 år og ≥ 70 år), der blev brugt ved randomiseringen.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines or vaccines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis De bruger anden medicin (eller vacciner) eller har gjort det for nylig.
English: ZOSTAVAX is used to vaccinate individuals 50 years of age or older.
Danish: ZOSTAVAX anvendes til vaccination af personer i alderen 50 år og derover.
English: * The table is based on the Modified Intent-To-Treat (MITT) population that included all subjects randomised in the study who were followed for at least 30 days post-vaccination and did not develop an evaluable case of zoster within the first 30 days post-vaccination.
Danish: * Tabellen er baseret på den modificerede intent-to-treat (ITT) population, der omfattede alle randomiserede forsøgspersoner i studiet, som blev kontrolleret i mindst 30 dage efter vaccination, og som ikke fik et evaluerbart zoster-tilfælde inden for de første 30 dage efter vaccination.
English: 1, Oka/Merck strain, (live, attenuated) not less than 19,400 PFU produced in human diploid (MRC-5) cells PFU = Plaque-forming units
Danish: 1, Oka/Merck-stamme, (levende, attenueret) ikke under 19.400 PFU produceret i humane diploide (MRC-5) celler PFU = Plaqueformende enheder
English: In SPS, the overall incidence of vaccine-related injection-site adverse reactions were 48% for ZOSTAVAX and 17% for placebo in subjects 60 years of age and older.
Danish: I SPS var den samlede incidens af vaccine-relaterede bivirkninger på injektionsstedet 48 % for ZOSTAVAX og 17 % for placebo hos forsøgspersoner på 60 år og derover.
English: See sections 4.8 and 5.1.
Danish: 4.8 og 5.1.
English: Table 7: VE† of ZOSTAVAX against postherpetic neuralgia (PHN) over the study period and on average over 3 and 5 years, by age at vaccination.
Danish: Tabel 7: VE† af ZOSTAVAX mod postherpetisk neuralgi (PHN) i studieperioden og gennemsnitligt i løbet af 3 og 5 år, ud fra alder på vaccinationstidspunktet.
English: ZOSTAVAX is available in packs of 1, 10 or 20 with or without needles.
Danish: ZOSTAVAX fås i pakninger af 1, 10 eller 20 stk. med eller uden kanyler.
English: If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be given under the skin.
Danish: Hvis De har en sygdom, der vedrører blodets evne til at størkne, eller hvis De har for få blodplader i blodet, bliver indsprøjtningen givet under huden.
English: Herpes zoster/herpes zoster-like rashes and Varicella/varicella-like rashes in clinical trials In clinical trials the number of herpes zoster/herpes zoster-like rashes within the 42-day postvaccination was low in both ZOSTAVAX and placebo groups.
Danish: Herpes zoster/herpes zoster-lignende udslæt og varicella/varicella-lignende udslæt i kliniske studier I kliniske studier var antallet af herpes zoster/herpes zoster-lignende udslæt inden for 42 dage efter vaccination lav i både ZOSTAVAX-gruppen og placebogruppen.
English: Table 1 presents vaccine-related injection-site and systemic adverse reactions reported at a significantly greater incidence in the vaccine group versus the placebo group within 42 days postvaccination in the ZOSTAVAX Efficacy and Safety trial (ZEST) study and in the Adverse Event Monitoring Substudy of Shingles Prevention Study (SPS).
Danish: Tabel 1 viser vaccinerelaterede systemiske og injektionsstedforbundne bivirkninger, som blev rapporteret langt hyppigere i vaccinegruppen sammenlignet med placebogruppen inden for 42 dage efter vaccination i ZOSTAVAX Efficacy and Safety Trial (ZEST-studiet) og i et sekundært studie af bivirkninger i Shingles Prevention Study (SPS-studiet).
English: Clinical trials experience.
Danish: Rapporteret i kliniske studier.
English: • Common (may affect up to 1 in 10 people): Warmth, bruising, hard lump, and rash at the injection site*; headache*; pain in the arm or leg*; joint pain, muscle pain; fever; rash
Danish: • Almindelige (kan forekomme hos op til 1 ud af 10 personer): varmefornemmelse, blå mærker, en hård knude og udslæt på injektionsstedet*, hovedpine*, smerter i arme eller ben*, ledsmerter, muskelsmerter, feber, udslæt.
English: • Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukaemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/AIDS (see sections 4.4, 4.8 and 5.1); cellular immune deficiencies.
Danish: • Primære og erhvervede immundefektsygdomme som følge af tilstande såsom: akut og kronisk leukæmi, lymfomer, andre sygdomme, som påvirker knoglemarven eller lymfesystemet, immunsuppression pga. HIV/AIDS (se pkt.
English: Individuals should receive a single dose (0.65 mL).
Danish: Vaccinationen skal gives i en enkelt dosis (0,65 ml).
English: Reduction of zoster pain severity-by-duration in vaccinated individuals who developed zoster With regard to the acute pain (pain between 0-30 days) there was no statistically significant difference between the vaccine group and the placebo group.
Danish: For så vidt angår akutte smerter (smerter mellem 0-30 dage), var der ingen statistisk signifikant forskel mellem vaccinegruppen og placebogruppen.
English: One pack of ZOSTAVAX contains a vial and a pre-filled syringe with or without attached needles.
Danish: En pakning med ZOSTAVAX indeholder et hætteglas og en forfyldt injektionssprøjte med eller uden påmonteret kanyle.
English: MedDRA System Organ Class
Danish: Systemorganklasse
English: VE estimates by age at vaccination and average VE estimates over the first 3 and 5 years postvaccination are shown below (see Table 6).
Danish: VE-estimater ud fra alder på vaccinationstidspunktet og gennemsnitlige VE-estimater i løbet af de første 3 og 5 år efter vaccination er vist nedenfor (se tabel 6).
English: Table 6: VE† of ZOSTAVAX against HZ over the study period and on average over 3 and 5 years, by age at vaccination.
Danish: Tabel 6: VE† af ZOSTAVAX mod HZ i studieperioden og gennemsnitligt i løbet af 3 og 5 år, ud fra alder på vaccinationstidspunktet.
English: VE estimates by age at vaccination and average VE estimates over the first 3 and 5 years postvaccination are shown below (see Table 7).
Danish: VE-estimater ud fra alder på vaccinationstidspunktet og gennemsnitlige VE-estimater i løbet af de første 3 og 5 år efter vaccination er vist nedenfor (se tabel 7).
English: Based on limited data from 2 clinical trials that enrolled VZV-seronegative or low seropositive subjects (30 years of age or older) receiving live attenuated zoster vaccine, injection site and systemic adverse experiences were generally similar to those reported by other subjects who received ZOSTAVAX in clinical trials, with 2 of the 27 subjects reporting fever.
Danish: På grundlag af begrænsede data fra 2 kliniske studier med VZV-seronegative eller lavt seropositive forsøgspersoner (på 30 år eller derover), som fik levende, svækket zoster-vaccine, blev der set reaktioner på injektionsstedet og systemiske bivirkninger, der alt i alt svarede til dem, der blev rapporteret af andre forsøgspersoner, som fik ZOSTAVAX i kliniske studier, med 2 ud af 27 forsøgspersoner der rapporterede feber.
English: ‡ Age strata at randomisation were 60-69 and ≥70 years of age.
Danish: † Aldersstrata ved randomiseringen var 60-69 år og ≥ 70 år.
English: Of the 295 ZOSTAVAX recipients, one case of serious vaccine related maculo-papular rash was reported on Day 4 following Dose 1 of ZOSTAVAX (see section 4.3).
Danish: Ud af de 295 ZOSTAVAX-vaccinerede forsøgspersoner blev der rapporteret ét tilfælde af alvorligt vaccine-relateret makulopapuløst udslæt på Dag 4 efter Dosis 1 af ZOSTAVAX (se pkt.
English: Inject the vaccine.
Danish: Injicer vaccinen.
English: However, among vaccinated individuals who developed PHN, ZOSTAVAX significantly reduced PHN-associated (chronic) pain compared with placebo.
Danish: Blandt vaccinerede patienter, som udviklede PHN, reducerede ZOSTAVAX dog PHN-associerede (kroniske) smerter signifikant i forhold til placebo.
English: Reconstitution instructions
Danish: Rekonstitutionsanvisninger
English: Overall, among vaccinated individuals who developed zoster, ZOSTAVAX significantly reduced overall acute and chronic zoster-associated pain compared with placebo.
Danish: Blandt vaccinerede patienter, som udviklede herpes zoster, medførte ZOSTAVAX alt i alt en signifikant reduktion af de generelle akutte og kroniske zosterassocierede smerter i forhold til placebo.
English: Solvent for ZOSTAVAX
Danish: Solvens til ZOSTAVAX
English: It is unknown whether VZV is secreted in human milk.
Danish: Det vides ikke, om VZV udskilles i modermælken.
English: ZOSTAVAX is not recommended to be administered to pregnant women.
Danish: ZOSTAVAX anbefales ikke til gravide kvinder.
English: ZOSTAVAX is indicated for prevention of herpes zoster (“zoster” or shingles) and herpes zoster-related post-herpetic neuralgia (PHN).
Danish: ZOSTAVAX er indiceret til forebyggelse af herpes zoster (“zoster” eller helvedesild) og herpes zosterrelateret postherpetisk neuralgi (PHN).
English: 60 years of age and older
Danish: 80+ år
English: Injection site urticaria
Danish: Urticaria på injektionsstedet
English: The VZV-specific immune responses to vaccine 6 weeks post-vaccination was comparable in the booster dose and first dose group.
Danish: De VZV-specifikke immunresponser på vaccinen 6 uger efter vaccination var sammenlignelige i gruppen, der fik boosterdosen, og gruppen, der fik den første dosis.