natgillin/translations-raw huggingface dataset:
Hos småbørn var rødme og ømhed de mest almindeligt rapporterede forventelige lokale reaktioner, mens irritabilitet og usædvanlig gråd var de mest almindeligt rapporterede forventelige systemiske reaktioner.
In toddlers erythema and tenderness were the most commonly reported solicited local reactions; irritability and unusual crying were the most commonly reported solicited systemic reactions.
Der kunne detekteres et vist heterologt immunrespons mod A/H5N1/turkey/Turkey/05 (NIBRG23; clade 2.2) og A/H5N1/Indonesia (clade 2.1) efter både anden og tredje vaccination, hvilket tyder på, at clade 1-vaccine udviser krydsreaktivitet mod clade 2-stammer.
Some heterologous immune response against A/H5N1/turkey/Turkey/05 (NIBRG23; clade2.2) and A/H5N1/Indonesia (clade 2.1) was detectable both after the second and third vaccinations, indicating cross-reactivity of the clade 1 vaccine against clade 2 strains.
Præliminære data fra spontant indberettede hændelser og igangværende post-markedsføringsstudier (graviditetsregister og prospektivt, interventionsstudier) antyder ingen direkte eller indirekte skadevirkninger af vacciner adjuveret med MF59 med hensyn til graviditet, fertilitet, embryonal/føtal udvikling, fødsel eller udvikling efter fødslen.
Preliminary data from spontaneously reported events and ongoing post-marketing studies (pregnancy registry and prospective interventional study) do not suggest direct or indirect harmful effects on influenza vaccines adjuvanted with MF59 with respect to pregnancy, fertility, embryonic/foetal development, parturition, or post natal development.
Bivirkninger fra kliniske studier med voksne (18 år og derover).
Adverse reactions from clinical trials in adults (18 years old and above).
A/Vietnam/1194/2004 (H5N1)-lignende stamme (NIBRG-14)
A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14)
Hvis du får en af disse bivirkninger, skal du straks fortælle det til din læge eller på apoteket.
If any of these side effects occur, please tell your doctor or nurse immediately.
Blodplademangel, som kan medføre blødning eller blå mærker.
Low blood platelet count which can result in bleeding or bruising.
Neurologiske lidelser som encephalomyelitis (betændelse i centralnervesystemet) og en slags lammelse, som kaldes Guillain-Barrés syndrom.
Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome.
Vaccination beskyttede dyrene mod letal challenge med vira, der var homologe og heterologe med vaccinen.
Vaccination protected animals from lethal challenge with virus homologous and heterologous to the vaccine.
Vaccinen indeholder pr. 0,5 ml 9,75 mg squalen, 1,175 mg polysorbat og 1,175 mg sorbitantrioleat.
The vaccine contains per 0.5ml 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg
Smerte, hårdhed på injektionsstedet, rødme på injektionsstedet, hævelse på injektionsstedet eller smerte på injektionsstedet, muskelsmerter, hovedpine, svedtendens, træthed.
Pain, hardening of the skin at the injection site, injection site redness, injection site swelling, pain at the site of injection, aching muscles, headache, sweating, fatigue.
5.2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties Not applicable.
Data for sikkerhed i forbindelse med en boosterdosis af den nuværende Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticsformulering er begrænset til tre studier (V87P1, V87P2 og V87P1E1), som inkluderede 116 voksne og 56 ældre.
Data on safety of a booster dose of the current Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics formulation are limited to three trials (V87P1, V87P2 and V87P1E1) that included 116 adults and 56 elderly.
Denne indikation er baseret på immunogenicitetsdata fra raske forsøgspersoner fra 18 år og opefter efter administration af to doser af vaccinen indeholdende A/Vietnam/1194/2004 (H5N1)-lignende stamme (se pkt.
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/Vietnam/1194/2004 (H5N1)-like strain (see section 5.1).
GMR (95 % CI) dag 43 til dag 1 % SC (95 % CI) dag 43
GMR (95% CI) Day 43 to Day 1 % SC (95% CI) Day 43
Immunisering skal udføres ved intramuskulær injektion i m. deltoideus.
Method of administration Immunisation should be carried out by intramuscular injection into the deltoid muscle.
Oplysninger fra præ-kliniske studie
Information from non-clinical trials
Aktiv immunisering mod influenza A-H5N1-virus.
Active immunisation against H5N1 subtype of Influenza A virus.
Der gives en dosis på 0,5 ml.
One dose of 0.5 ml will be given.
Blod og lymfesystem Lymfadenopati.
Blood and lymphatic system disorders
Grupper på 6 fritter fik én dosis vaccine (dag 21) indeholdende 3,75 mikrogram antigen eller to doser vaccine (dag 0 og 21) indeholdende enten 1,0 eller 3,75 mikrogram antigen (A/Vietnam/1194/2004).
Groups of 6 ferrets received one dose of vaccine (day 21) containing 3.75 micrograms of antigen or two doses of vaccine (days 0 and 21) containing either 1.0 or 3.75 micrograms of antigen (A/Vietnam/1194/2004).
MN-resultater for de tre kliniske studier i ovenstående tabel viste en seroprotektionsrate og en serokonverteringsrate mod A/turkey/Turkey/05 i området fra henholdsvis 10 % (2-27) til 39 % (32-46) og 10 % (2-27) til 36 % (29-43).
MN results for the three clinical studies in the Table above revealed a seroprotection rate and seroconversion rate against A/turkey/Turkey/05 ranging from 10% (2-27) to 39% (32-46) and 10% (227) to 36% (29-43) respectively.
Tre uger efter den 2. vaccination (dag 43) havde alle aldersgrupper (dvs. 6-35 måneder, 3-8 år og 9-17 år) opnået høje antistofniveauer mod (A/Vietnam/1194/2004) evalueret med SRH- og HIassays, som vist i nedenstående tabel*.
nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below*.
Nervesystemet Neurologiske forstyrrelser, såsom encefalomyelitis og Guillain Barrés syndrom.
Neurological disorders, such as encephalomyelitis, and Guillain Barré syndrome.
Hovedpine, svimmelhed, døsighed, besvimelse.
Headache, dizziness, drowsiness, fainting.
Der blev udført et klinisk studier (Studie V87P1) med en H5N1-vaccine kombineret med MF59C.1adjuvans hos 312 raske voksne.
A clinical trial (Study V87P1) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 312 healthy adults.
29. november 2010
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29 November 2010
De prækliniske data opnået med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics og med sæsoninfluenzavaccine indeholdende MF59C.1-adjuvans viser ingen særlig risiko for mennesker ud fra konventionelle undersøgelser af toksicitet efter gentagne doser, lokal tolerance, kvindelig fertilitet og reproduktionstoksicitet og udvikling (til og med slutningen af amningsperioden).
Non-clinical data obtained with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
Almindelig: Blå mærker ved injektionsstedet, feber og kvalme, generel utilpashed og kulderystelser.
Common: Brusing of the skin at the injection site, fever and nausea, generally feeling unwell and shivering.
Der blev ikke rapporteret hyppigere bivirkninger, når en boosterdosis blev administreret 618 måneder efter den første dosis-serie.
No increase in reactions was reported when a booster dose is administered 6 months-18 months later after the initial dosing series.
En dosis på 0,5 ml indeholder: Aktive stoffer: Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase) dyrket i æg fra stammen:
STATEMENT OF ACTIVE SUBSTANCE One dose of 0.5 ml contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in eggs, of strain:
Data opnået fra voksne viste, at samtidig administration af adjuveret H5N1--vaccine og sæsonantigener (inaktiveret overflade, ikke adjuverede) ikke medførte nogen interferens for hverken sæsonstammer eller H5N1-stammer.
Data obtained in adults showed that co-administration of adjuvanted H5N1 vaccine and seasonal (inactivated surface, non-adjuvanted) antigens did not lead to any interference neither for seasonal strains nor for H5N1 strains.
Alle (100 %) dyr, der fik 2 doser Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, var beskyttet, og 94 % af de dyr, der fik en enkelt dosis Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, var beskyttet.
All (100%) animals receiving 2 doses of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics were protected, and 94% of animals receiving a single dose of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics were protected.
I et andet klinisk studier (Studie V87P13) blev der indrulleret 2693 voksne forsøgspersoner, som modtog to vaccinedoser indeholdende H5N1 (A/Vietnam/1194/2004; 7,5 µg HA/dosis adjuveret) med tre ugers mellemrum.
In another clinical trial (Study V87P13) 2693 adult subjects were enrolled and received two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) administered three weeks apart.
En mindre infektion, såsom en forkølelse, er normalt ikke nogen hindring, men din læge eller sygeplejerske afgør, om du alligevel kan vaccineres med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
A minor infection such as a cold should not be a problem, but your doctor or nurse should advise whether you could still be vaccinated with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated,
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX
Forekomsten af bivirkninger er blevet evalueret i seks kliniske studier omfattende ca. 4000 voksne og ældre, der modtog Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (mindst 7,5 µg HA, adjuveret).
The incidence of adverse reactions has been evaluated in six clinical trials involving approximately 4,000 adults and elderly receiving (Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics at least 7.5 µg HA, adjuvanted).
Seroprotektionsrate (95 % CI) * Serokonverteringsrate (95 % CI)* Serokonverteringsfaktor (95 % CI)**
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Bivirkningsovervågning efter markedsføring
Post-marketing surveillance
Neurologiske lidelser såsom neuralgi, paræstesi, kramper og neuritis.
Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Hud og subkutane væv Generaliserede hudreaktioner inklusive pruritus, urticaria eller uspecifikt udslæt; angioødem.
Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Da 2 doser anbefales, skal det bemærkes, at der ikke foreligger data om sikkerhed, immunogenicitet og virkning, der understøtter muligheden for at erstatte Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics med andre monovalente H5N1-vacciner.
Since a second dose is recommended, it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics with other H5N1 monovalent vaccines.
Knogler, led, muskler og bindevæv Muskelsvaghed, smerter i ekstremiteter.
Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
De foreliggende data mellem 6 månader og 18 år er beskrevet i pkt.
Currently available data in subjects aged 6 months to 18 years of age are described in section 5.1 but no recommendation on a posology can be made.
Knogler, led, muskler og bindevæv Meget almindelig: myalgi Almindelig: artralgi
Muscoskeletal, connective tissue and bone disorders Very common: myalgia
Der blev udført et klinisk studie (Studie V87P6), hvor en kombination af H5N1-vaccinen og MF59C.1-adjuvans blev givet til 471 børn i alderen 6 måneder til 17 år.
A clinical trial (Study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 471 children from 6 months to 17 years of age.
Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase)* fra stammen:
QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics er blevet evalueret hos raske voksne (18-60 år) og raske ældre (over 60 år) efter et dag 1 - dag 22 primært vaccinationsprogram samt boostervaccination (se pkt.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics has been evaluated in healthy adults (18-60 years of age) and healthy elderly (over 60 years of age) following a 1, 22 day primary vaccination schedule, and booster vaccination (see sections 4.8 and 5.1).
Samtidig administration var ikke hyppigere forbundet med lokale eller systemiske reaktioner sammenlignet med administration af Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics alene.
Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics alone.
Følgende utilsigtede hændelser er indberettet fra overvågning efter markedsføring af Focetria H1N1v (godkendt til brug fra alderen 6 måneder og med en sammensætning, der ligner Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticss):
The following additional adverse events were reported from post-marketing surveillance with Focetria H1N1v (licensed for use from 6 months of age and with a composition that is similar to Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics):
Seroprotektionsrate*, serokonverteringsrate* og serokonverteringsfaktor** for anti-HA antistof mod H5N1 A/Vietnam/1194/2004 hos forsøgspersoner på over 60 år (et begrænset antal forsøgspersoner var over 70 år) målt ved SRH-assay vurderet i to kliniske forsøg studier var som følger:
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in subjects aged over 60 (limited number of subjects were above 70 years of age) measured by SRH assay assessed in two clinical studies were as follows:
I tilfælde af en officielt erklæret influenzapandemi forårsaget af A/H5N1-virus kan personer, der tidligere er vaccineret med en eller to doser Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics indeholdende HA-antigen udvundet af en anden clade af den samme influenza-undertype som influenzapandemi-stammen, modtage en enkelt dosis Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics i stedet for de to doser, der kræves til hidtil uvaccinerede personer (se pkt.
In the event of an officially declared influenza pandemic due to A/H5N1 virus, persons previously vaccinated with one or two doses of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics that contained HA antigen derived from a different clade of the same influenza subtype as the influenza pandemic strain may receive a single dose of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics instead of two doses that are required in previously unvaccinated individuals (see section 5.1).
Det anslås, at mere end 90.000 kvinder er blevet vaccineret under graviditeten med H1N1v-vaccinen Focetria, som indeholder samme mængde adjuvans MF59C.1 som Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
It is estimated that more than 90,000 women have been vaccinated during pregnancy with H1N1v vaccine Focetria which contains the same amount of adjuvant MF59C.1 as. Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics However information on outcomes is currently limited.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, indeholdende HA fra A/Vietnam/1194/2004 (homolog med challenge-stammen), og en Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnosticslignende H5N1 vaccine, indeholdende hæmagglutinin fra A/turkey/Turkey/1/2005-lignende (heterolog med challenge-stammen) blev testet.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics containing HA from A/Vietnam/1194/2004 (homologous to the challenge strain) and an Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics -like H5N1 vaccine, containing hemagglutinin from the A/turkey/Turkey/1/2005-like (heterologous to the challenge strain) were tested.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics er en vaccine til brug hos voksne (fra 18 til 60 år) og ældre (over 60 år).
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults (from 18 to 60 years old).
En enkelt vaccination med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) fremkaldte et højt og hurtigt serologisk respons hos forsøgspersoner, der var blevet primet 6-8 år tidligere med to doser af en anden H5N-surrogatvaccine med samme formulering som Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics men ved anvendelse af stammen H5N3.
A single vaccination with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) induced high and rapid serological response in subjects primed 6-8 years previously with two doses of a different surrogate H5N vaccine, having same formulation as Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics but using the strain H5N3.
Seroprotektionsrate (95 % CI)* Serokonverteringsrate (95 % CI)* Serokonverteringsfaktor (95 % CI)** * målt ved SRH-assay ≥ 25 mm ** geometriske middelratioer af SRH
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)** * measured by SRH assay ≥ 25 mm2
En tredje (booster-) dosis Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics blev administreret 6 måneder og derefter efter den primære vaccination.
A third (booster) dose of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics was administered 6 months onwards after the primary vaccination.
Der blev administreret to doser Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics med tre ugers mellemrum samt en tredje dosis 12 måneder efter den første dosis.
Two doses of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics were administered three weeks apart and a third dose 12 months following the first dose.
De potentielle fordele for moderen og risici for barnet skal overvejes, før Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics administreres under amning
The potential benefits to the mother and risks to the infant should be considered before administering Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics during breast-feeding.
MN-resultater mod A/Vietnam/1194/2004 tyder på en seroprotektions- og serokonverteringsrate i området fra henholdsvis 67 % (60-74) til 85 % (78-90) og 65 % (58-72) til 83 % (77-89).
MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively.
FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION
Sjælden: Kramper, hævede øjne, anafylaktisk shock.
Rare: Convulsions, eye swelling and anaphylaxis.
Immunresponset var lavere i gruppen, der fik den 2. dosis efter 1 uge og højere i grupper med længere intervaller i programmet.
week later and higher in the groups with longer interval schedules.
Som med alle vacciner er det ikke sikkert, at Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics beskytter alle vaccinerede personer fuldstændigt.
As with all vaccines, Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics may not fully protect all persons who are vaccinated.
MN-resultater mod A/Vietnam/1194/2004 tyder på en seroprotektions- og serokonverteringsrate i området fra henholdsvis 57 % (50-64) til 79 % (68-87) og 55 % (48-62) til 58 % (47-69).
MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from of 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69) respectively.
Mave-tarm-kanalen Almindelig: kvalme
Gastrointestinal disorders Common: nausea
I et klinisk fase 2-studie (Studie V87P3) fik voksne forsøgspersoner på 18-65 år, som var primet 6-8 år tidligere med 2 doser MF59-adjuveret H5N3-vaccine /A/Duck/Singapore/97, 2 boosterdoser Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
In a phase 2 clinical trial (Study V87P3) adult subjects aged 18-65 years primed 6-8 years previously with 2 doses of MF59-adjuvanted H5N3 vaccine /A/Duck/Singapore/97 were administered 2 booster doses of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics SRH results after the first dose, that mimic prepandemic priming plus single heterologous booster dose, met all CHMP criteria.
Dette punkt beskriver den kliniske erfaring med Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics efter administration af to doser samt en booster.
This section describes the clinical experience with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics following a two-dose administration and booster.