natgillin/translations-raw huggingface dataset:
In a third clinical trial (V87P11) 194 adult subjects were enrolled and received two doses of AFLUNOV (A/turkey/Turkey/1/2005) administered three weeks apart.
U treće kliničko ispitivanje (V87P11) uključene su 194 odrasle osobe koje su primile dvije doze cjepiva AFLUNOV (A/turkey/Turkey/1/2005) u razmaku od tri tjedna.
MN results against homologous A/turkey/Turkey/1/2005 indicate a seroconversion rate of 66.67% in healthy adults, and ranging from 33.57% to 54.14% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 24.39% to 29.03% in healthy elderly subjects, and from 31.65% to 39.42% in elderly subjects with immunosuppressive or underlying medical conditions.
Rezultati za MN protiv homolognog virusa podtipa A/turkey/Turkey/1/2005 ukazuju na stopu serokonverzije od 66,67% u zdravih odraslih, i kreće se od 33,57% do 54,14% u odraslih s imunosupresijom odnosno postojećim medicinskim stanjem; stope serokonverzije kretale su se od 24,39% do 29,03% u zdravih starijih ispitanika i od 31,65% do 39,42% u starijih ispitanika s imunosupresijom ili postojećim medicinskim stanjem.
Toddlers (6-<36 months)
Mala djeca (6-<36 mjeseci)
Common (≥1/100 to <1/10)
Često (≥1/100 i
There are no data on co-administration of AFLUNOV with vaccines other than non-adjuvanted seasonal influenza vaccines.
Nema podataka o istodobnoj primjeni cjepiva AFLUNOV s drugim cjepivima osim neadjuvantiranih sezonskih cjepiva protiv influence.
To be administered intramuscularly into the deltoid muscle.
Primjenjuje se intramuskularno u deltoidni mišić.
These side effects may occur with AFLUNOV.
Te se nuspojave mogu pojaviti s cjepivom AFLUNOV.
In addition, duration a pandemic, resources needed for an in-depth evaluation of PSURs in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
tijekom pandemije, resursi potrebni za dubinsku procjenu PSUR-eva u formatu definiranom u Svesku 9a Pravilnika koji uređuje lijekove u Europskoj
Rare (affects 1 to 10 users in 10.000):
Rijetko (javlja se u 1 do 10 na 10 000 korisnika):
- Active Substance: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Djelatna tvar: Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)* soja:
• Sweating
• Drhtanje • Znojenje
MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
Rezultati MN analiza na virus A/Vietnam/1194/2004 upućuju na stopu seroprotekcije od 99% (95%CI: 94-100), stopu serokonverzije u rasponu od 97% (95%CI: 91-99) do 99% (95%CI: 96-100) i omjer srednje geometrijske vrijednosti (GMR) u rasponu od 29 (95%CI: 25-35) do 50 (95%CI: 44-58).
Blood and lymphatic system disorders Lymphadenopathy.
Poremećaji krvi i limfnog sustava
Method of administration Immunisation should be carried out by intramuscular injection into the deltoid muscle.
Imunizacija se provodi intramuskularnom injekcijom u deltoidni mišić.
In this trial no vaccine related SAEs were observed.
U ovom ispitivanju nisu zabilježeni ozbiljni štetni događaji povezani s cjepivom.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1 and to residues (eggs and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide).
Potreban je oprez pri primjeni cjepiva u osoba s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, na bilo koju od pomoćnih tvari navedenih u dijelu 6.1 i na tvari u tragovima (jaja i pileće proteine, ovalbumin, kanamicin, neomicinsulfat, formaldehid i cetiltrimetilamonijev bromid).
AFLUNOV(A/Vietnam/1194/2004) and an AFLUNOV-like H5N1 vaccine (A/turkey/Turkey/1/2005-like) were tested.
Testirano je AFLUNOV (A/Vietnam/1194/2004) i H5N1-slično cjepivo AFLUNOV (A/turkey/Turkey/1/2005-sličan soj).
Periodic Safety Update Reports (PSURs)
Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama
In phase III clinical trial (V87P13) 2693 adult subjects were enrolled and 2566 received two doses of AFLUNOV (A/Vietnam/1194/2004) administered three weeks apart.
U kliničko ispitivanju faze III (V87P13) uključene su 2693 odrasle osobe od kojih je 2566 primilo dvije doze cjepiva AFLUNOV (A/Vietnam/1194/2004) primijenjene u razmaku od tri tjedna.
• Brusing of the skin at the injection site
• Otvrdnuće kože na mjestu injekcije
Adults (19- 60 years)a
Odrasli (19-60 godina) a
In Study V87P11 MN results against homologous A/turkey/Turkey/1/2005) indicate a seroprotection and seroconversion rate of 85% (79-90) and 93% (89-96), respectively.
Rezultati MN analize u Studiji V87P11 na homologni virus A/turkey/Turkey/1/2005 upućuju na stopu seroprotekcije i serokonverzije od 85% (79-90), odnosno 93% (89-96).
Very common (affects more than 1 user in 10):
Vrlo često (javlja se u više od 1 na 10 korisnika):
Elderly (>61 years)
Starije osobe (≥61 godina)
Common (affects 1 to 10 users in 100):
Često (javlja se u 1 do 10 na 100 korisnika):
Vaccination protected animals from lethal challenge even when HI antibody titres were low or undetectable.
Cijepljenje je zaštitilo životinje od letalnog ishoda čak i kad su titri protutijela
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB) (see section 6.
• ako ste imali bilo koju alergijsku reakciju osim nagle, po život opasne alergijske reakcije na bilo koji sastojak cjepiva, na jaja i pileće bjelančevine, ovalbumin, formaldehid, kanamicin i neomicinsulfat (antibiotici) ili cetiltrimetilamonijev bromid (CTAB) (pogledajte dio 6. za dodatne informacije);
Medical Conditions N=143
Medicinsko stanje N=143
MN results for A/Vietnam/1194/2004 revealed a seroprotection rate of 10% (6-16) in adults (18-60 years) and 6% (3-11) in elderly (>61 years); a seroconversion rate of 19% (13-25) in adults and 7% (4-13) in elderly and finally a GMR of 1.86 (1.63-2.12) in adults and 1.33 (1.17-1.51) in elderly.
Rezultati MN analize za virus A/Vietnam/1194/2004 pokazali su stopu seroprotekcije od 10% (6-16) u odraslih osoba (18-60 godina) i 6% (3-11) u starijih osoba (≥61 godina): stopu serokonverzije od 19% (13-25) u odraslih osoba i 7% (4-13) u starijih osoba te omjer srednje geometrijske vrijednosti (GMR) od 1,86 (1,63-2,12) u odraslih osoba i 1,33 (1,17-1,51) u starijih osoba.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač: Nositelj odobrenja za stavljanje lijeka u promet
Cross-reactive immune response elicited by A/turkey/Turkey/1/2005 against A/Indonesia/5/2005 and A/Vietnam/1194/2004
Križno reaktivan imunološki odgovor izazvan virusom A/turkey/Turkey/1/2005 na viruse A/Indonesia/5/2005 i A/Vietnam/1194/2004
HI Seroprotection rate (95%CI)°
HI Stopa seroprotekcije (95%CI)°
** Seroconversion was defined as an SRH area ≥25 mm2 for subjects who were seronegative at baseline (Day 1 SRH area ≤4 mm2) or a significant (at least 50%) increase in SRH area for subjects who were seropositive at baseline (Day 1 SRH area >4 mm2) *** geometric mean ratios (GMRs) of SRH
** Serokonverzija je definirana kao SRH površina ≥25 mm2 u ispitanika koji su bili seronegativni na početku ispitivanja (SRH površina 1. dana ≤4 mm2) ili značajni (najmanje 50%-tni) porast SRH površine za ispitnike koji su bili seropozitivni na početku ispitivanja (površina SRH 1. dana >4 mm2) *** GMR vrijednosti SRH ° izmjereno HI analizom ≥40 °° GMR vrijednosti HI-a
In children and adolescents, pain was the most frequently reported solicited local reaction, and fatigue and headache were the most commonly reported solicited systemic reactions.
dok su umor i glavobolja bili najčešće prijavljene izazvane sistemske reakcije.
V87P11 Elderly (>61-89 years)a N=142
V87P11 Starije osobe (6189 godina) a N=142
Adults (20- 60 years)a
Odrasli (20-60 godina) a
Seroconversion rates against homologous A/turkey/Turkey/1/2005 ranged from 37.50% to 43.10% in healthy adults, and from 19.18% to 26.47% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 21.43% to 30.65% in healthy elderly subjects, and from 24.49% to 27.86% in elderly subjects with immunosuppressive or underlying medical conditions.
Stope serokonverzije protiv homolognog virusa podtipa A/turkey/Turkey/1/2005 kretale su se od 37,50% do 43,10% u zdravih odraslih, i od 19,18% do 26,47% u odraslih s postojećom imunosupresijom ili medicinskim stanjem; stope serokonverzije su se kretale od 21,43% do 30,65% u zdravih odraslih ispitanika, i od 24,49% do 27,86% u starijih ispitanika s imunosupresijom ili postojećim medicinskim stanjem.
MN results for A/Indonesia/5/2005 revealed a seroprotection rate of 38% (31-45) in adults (18-60 years) and 14% (8-20) in elderly (>61 years); a seroconversion rate of 58% (50-65) in adults and 30% (23-38) in elderly and finally a GMR of 4.67 (3.95-5.56) in adults and 2.19 (1.86-2.58) in elderly.
Rezultati MN analize za virus A/Indonesia/5/2005 pokazali su stopu seroprotekcije od 38% (31-45) u odraslih osoba (18-60 godina) i 14% (8-20) u starijih osoba (≥61 godina): stopa serokonverzije od 58% (50-65) u odraslih osoba i 30% (23-38) u starijih osoba te omjer srednje geometrijske vrijednosti (GMR) od 4,67 (3,95-5,56) u odraslih osoba i 2,19 (1,86-2,58) u starijih osoba.
Efficacy against challenge with virus homologous and heterologous to vaccine strains was evaluated in the ferret model.
Djelotvornost je procijenjena na modelu tvorova pokusom s virusom koji je homologan i heterologan sojevima cjepiva.
Post-marketing surveillance No post-marketing surveillance data are available following AFLUNOV administration.
Nema dostupnih podataka o praćenju nakon stavljanja gotovog lijeka u promet nakon primjene cjepiva AFLUNOV.
and a type of paralysis known as Guillain-Barré Syndrome.
• Neurološki poremećaji kao što su encefalomijelitis (upala središnjeg živčanog sustava) i vrsta paralize koja se naziva Guillain-Barréov sindrom
MN results against homologous A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69), respectively.
Rezultati MN analize na homologni virus A/Vietnam/1194/2004 upućuju na stopu seroprotekcije i serokonverzije u rasponu od 57% (50-64) do 79% (68-87), odnosno od 55% (48-62) do 58% (47-69).
a actual age range of population enrolled * Seroprotection: SRH area≥25 mm2
a trenutni raspon dobi populacije uključene u ispitivanje * mjereno SRH analizom seroprotekcije: SRH površina ≥25 mm2, serokonverzija: SRH površina ≥25 mm2
The vaccine will be injected into the muscles of the upper arm (deltoid muscle).
Cjepivo se injicira u mišiće nadlaktice (deltoidni mišić).
• Urticaria (hives).
• Koprivnjača (urtikarija)
Nervous system disorders
Poremećaji živčanog sustava glavobolja konvulzije
Seroconversion rate (95%CI)°
Stopa serokonverzije (95%CI)°
MicroNeutralisation (MN) results against homologous 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.
Rezultati mikroneutralizacije (MN) na homologni virus A/Vietnam/1194/2004 upućuju na stopu seroprotekcije i serokonverzije u rasponu od 67% (60-74) do 85% (78-90), odnosno od 65% (58-72) do 83% (77-89).
AFLUNOV may contain trace residues of egg and chicken proteins, ovalbumin, kanamycin, neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide which are used during the manufacturing process (see section 4.3).
neomicinsulfata, formaldehida i cetiltrimetilamonijeva bromida koji se upotrebljavaju tijekom postupka proizvodnje (vidjeti dio 4.3).
Cross-reactive immune response elicited by A/Vietnam/1194/2004 against A/turkey/Turkey/1/2005 and A/Indonesia/5/2005
Križno reaktivan imunološki odgovor izazvan virusom A/Vietnam/1194/2004 na viruse A/turkey/Turkey/1/2005 i A/Indonesia/5/2005
Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Poremećaji živčanog sustava Glavobolja, omaglica, somnolencija, sinkopa, neurološki poremećaji poput neuralgije, parestezije,
In Study V87P11, MN results against homologous A/turkey/Turkey/1/2005 indicate a seroprotection and seroconversion rate of 68% (59-75) and 81% (74-87), respectively.
Rezultati MN analize u Studiji V87P11 na homologni virus A/turkey/Turkey/1/2005 upućuju na stopu seroprotekcije i serokonverzije od 68% (59-75) odnosno 81% (74-87).
Elderly (61-84 years)a
Starije osobe (61-84 godine) a
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOG II. A. PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=182
Studija V87P11 A/turkey/Turkey/1/2005 21 dan nakon 2. doze N=182
Elderly (61-79 years)a
Starije osobe (61-79 godina) a
Study V87P3 21 days after 2nd dose N=30
Studija V87P3 21 dan nakon 2. doze N=30
• Shivering
• Trnci
Study V87P1 Elderly booster after 2nd dose
Studija V87P1 starije osobe booster nakon 2. doze
Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=132c
Studija V87P11 A/turkey/Turkey/1/2005 21 dan nakon 2. doze N=132c
Urticaria
Kašalj
Study V87P13 21 days after 2nd dose N=197
Studija V87P13 21 dan nakon 2. doze N=197
Study V87P2 Adults booster after 2nd dose
Studija V87P2 odrasli booster nakon 2. doze
% SC (95% CI) Day 43
% seroprotekcije (95% CI) 43. dan
The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows:
Stopa seroprotekcije*, stopa serokonverzije** i čimbenik serokonverzije*** za anti-HA protutijela na virus H5N1 A/Vietnam/1194/2004 izmjereni SRH analizama bili su sljedeći:
Limited data were obtained from women who became pregnant during the course of clinical trials with AFLUNOV or similar pandemic H1N1v vaccines adjuvanted with MF59C.1.
AFLUNOV ili sličnim pandemijskim H1N1v cjepivima adjuvantiranim s MF59C.1.
Geometric Mean Area (95%CI)* Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Srednja geometrijska vrijednost površine (95% CI)* Stopa seroprotekcije (95% CI)* Stopa serokonverzije (95% CI)* Faktor serokonverzije (95% CI)**
The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 and to H5N1 A/turkey/Turkey/1/2005 in the adults measured by SRH assay was as follows:
Stopa seroprotekcije*, stopa serokonverzije** i čimbenik serokonverzije*** za anti-HA protutijela na virus H5N1 A/Vietnam/1194/2004 i na virus H5N1 A/turkey/Turkey/1/2005 u odraslih osoba izmjereni SRH analizom bili su sljedeći:
AFLUNOV suspension for injection in pre-filled syringe.
AFLUNOV suspenzija za injekciju u napunjenoj štrcaljki.
Elderly (61-91 years)a
Starije osobe (61-91 godina) a
Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/turkey/Turkey/1/2005 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
Stopa seroprotekcije*, stopa serokonverzije** i čimbenik serokonverzije*** za anti-HA protutijela na virus H5N1 A/turkey/Turkey/1/2005 nakon 2. doze u odraslih osoba u dobi od 18 do 60 godina, izmjereni SRH i HI analizama bili su sljedeći:
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide) of this vaccine.
Anamneza anafilaktičke (tj. po život opasne) reakcije na bilo koji sastojak ovog cjepiva ili na ostatne tvari koje se u cjepivu nalaze u tragovima (jaja i pileće proteine, ovalbumin, kanamicin, neomicinsulfat, formaldehid i cetiltrimetilamonijev bromid.
Study V87P1 Adults booster after 2nd dose
Studija V87P1 odrasli booster nakon 2. doze
Breast-feeding
Limfadenopatija
Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/ Indonesia/5/2005 and A/Vietnam/1194/2004 after the 2nd dose in adults (18-60 years) and elderly (> 61years), measured by SRH and HI assays were as follows: Anti-HA antibody
Stopa seroprotekcije*, stopa serokonverzije** i čimbenik serokonverzije*** za anti-HA protutijela na viruse H5N1 A/ Indonesia/5/2005 i A/Vietnam/1194/2004 nakon 2. doze u odraslih osoba (18-60 godina) i starijih osoba (≥61 godina), izmjereni SRH i HI analizama bili su sljedeći:
Cardiac disorders Palpitation, tachycardia.
Palpitacije, tahikardija
% SP (95% CI) Day 43 GMR Day 43 to Day 1 % SC (95% CI)Day 43
% seroprotekcije (95% CI) 43. dan Omjer srednje geometrijske vrijednosti (GMR) 43. dan do 1. dan
Injection site swelling, Injection site pain, Injection site induration, Injection site redness, Fatigue
otvrdnuće na mjestu injekcije, crvenilo na mjestu injekcije, umor ekhimoza na mjestu injekcije,
assays) and reduced seroprotection rates in adults and elderly (≥ 61 years old) subjects with underlying medical or immunosuppressive conditions, suggest that AFLUNOV may not elicit the same level of protection against A/H5N1 strain as compared to healthy adults (see section 4.4).
U oba ispitivanja, V87_25 i V87_26, niže razine protutijela (izmjerenih analizom HI, SRH i MN) i smanjene stope seroprotekcije u odraslih i starijih ispitanika (≥61 godina) s postojećim medicinskim stanjem ili stanjem imunosupresije, upućuju na to da cjepivo AFLUNOV ne mora izazvati jednaku razinu zaštite protiv soja virusa A/H5N1 kao u zdravih odraslih (vidjeti dio 4.4).
(A/Vietnam/1194/2004) dose, all vaccine schedule groups after 3 weeks from the 2nd vaccination achieved high levels of antibodies as evaluated with SRH.
Tri tjedna nakon 2. cijepljenja su u svim skupinama, određenim prema rasporedu cijepljenja, postignute visoke razine antitijela kako je procijenjeno s SRH.
The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 (A/Vietnam/1194/2004 and to A/ turkey/Turkey/1/2005) in subjects aged 61 years and older (limited number of subjects were above 70 years of age; n=123) measured by SRH assay assessed in three clinical studies were as follows:
Stopa seroprotekcije*, stopa serokonverzije** i čimbenik serokonverzije*** za anti-HA protutijela na virus H5N1 (A/Vietnam/1194/2004 i na virus A/turkey/Turkey/1/2005) u ispitanika u dobi od 61 godinu i starijih (ograničen broj ispitanika bio je stariji od 70 godina; N=123) izmjereni SRH
Fainting can occur following, or even before, any needle injection.
Nakon, ili čak i prije bilo kojeg uboda iglom može se javiti nesvjestica.
• Fever and nausea
• Vrućica i mučnina • Opće loše osjećanje
Vascular disorders Vasculitis with transient renal involvement.
Krvožilni poremećaji Vaskulitis s prolaznom zahvaćenošću bubrega
GMR (95% CI) Day 43 to Day 1
Omjer srednje geometrijske vrijednosti (GMR) (95% CI) 43. dan do 1. dan
There is no information on administration of AFLUNOV with noninfluenza vaccines.
Nema podataka o primjeni cjepiva AFLUNOV s cjepivima koja nisu cjepiva protiv gripe.
• Pain at the site of injection
• Bol na mjestu injekcije
• Nausea
• Svrbež
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of AFLUNOV (listed in section 6) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB).
AFLUNOV (navedeni u dijelu 6) ili na bilo koju tvar koja može biti prisutna u tragovima kako slijedi: jaje i pileće bjelančevine, ovalbumin, formaldehid, kanamicin i neomicinsulfat (antibiotici) ili cetiltrimetilamonijev bromid (CTAB).
Anti-HA antibody Study V87P12 21 days after 2nd dose N=60
Studija V87P12 21 dan nakon 2. doze N=60
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor (95%CI)*** a Ages 62-88 years; b Ages 61-68 years; c Ages 61-89 years * Seroprotection: SRH area ≥ 25 mm2
a dob 62-88 godina; b dob 61-68 godina; c dob 61-89 godina * Seroprotekcija: SRH površina ≥25 mm2 ** Serokonverzija je definirana kao SRH površina ≥25 mm2 u ispitanika koji su bili seronegativni na početku ispitivanja (SRH površina 1. dana ≤4 mm2) ili značajni (najmanje 50%-tni) porast
** geometric mean ratios of SRH
dana >4 mm2) *** omjeri srednje geometrijske vrijednosti (GMR, engl. geometric mean ratios) SRH-a
Baseline Serostatus
Početni serostatus
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor (95%CI)***
Stopa seroprotekcije (95%CI)* Stopa serokonverzije (95%CI)**
Skin and subcutaneous tissue disorders Erythema multiforme.
Poremećaji kože i potkožnog tkiva znojenje urtikarija oticanje oka
Reporting of side effects
Pomoćne tvari s pomoćnim učinkom
Study V87P1 A/Vietnam/1194/2004 21 days after 2nd dose N=84a
Studija V87P1 A/Vietnam/1194/200421 dan nakon 2. doze N=84a
Healthy
Zdravi
Geometric mean area*, seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/turkey/Turkey/1/2005 measured by SRH assays 21 days after the 2nd dose were as follows:
Srednja geometrijska vrijednost površine*, stope seroprotekcije*, stope serokonverzije* i faktora serokonverzije** za anti-HA protutijelo na H5N1 A/turkey/Turkey/1/2005 mjerenom analizom SRH
Study V87P1 A/Vietnam/1194/2004 21 days after 2nd dose N=149
Studija V87P1 A/Vietnam/1194/2004 21 dan nakon 2. doze N=149
In trial V87_25 and V87_26, 96 and 67 subjects, respectively, were over the age of 70 years.
U ispitivanju V87_25 bilo je 96 ispitanika starijih od 70 godina, dok ih je u ispitivanju V87_26 bilo 67. U oba ispitivanja su analize HI, SRH i MN nakon prve kao i nakon druge primijenjene doze pokazale imunogenost cjepiva AFLUNOV.
A clinical trial (V87P6) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 471 children from 6 months to 17 years of age.
(A/Vietnam/1194/2004) u 471 djeteta dobi od 6 mjeseci do 17 godina.
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=210b
Studija V87P13 A/Vietnam/1194/2004 21 dan nakon 2. doze N=210b
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=128
Studija V87P13 A/Vietnam/1194/2004 21 dan nakon 2. doze N=128
Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Slabost mišića, bol u udovima
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=66
Studija V87P13 A/Vietnam/1194/2004 21 dan nakon 2. doze N=66
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=69
Studija V87P13 A/Vietnam/1194/2004 21 dan nakon 2. doze N=69
** Seroconversion was defined as an SRH area ≥25 mm2 for subjects who were seronegative at baseline (Day 1 SRH area ≤4 mm2) or a significant (at least 50%) increase in SRH area for subjects who were seropositive at baseline (Day 1 SRH area >4 mm2) *** GMRs of SRH
(95%CI)°° * Seroprotekcija: SRH površina ≥25 mm2 ** Serokonverzija je definirana kao SRH površina ≥25 mm2 u ispitanika koji su bili seronegativni na početku ispitivanja (SRH površina 1. dana ≤4 mm2) ili značajni (najmanje 50%-tni) porast
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=143
Studija V87P13 A/Vietnam/1194/2004 21 dan nakon 2. doze N=143
Influenza like illness
Zaštita od influence
Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=197
Studija V87P13 A/Vietnam/1194/2004 21 dan nakon 2. doze N=197
• Headache
• Glavobolja • Umor
Respiratory disorders Cough.
Čimbenik serokonverzije
• Eye swelling
• Oticanje oka