Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects
31. prosince 2013 aktualizováno: Novartis
A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of an H5N1-vaccine and a Seasonal Influenza Vaccine in Adult Subjects
This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
405
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Bogotà, Kolumbie
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 40 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Healthy subjects
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Concomitant alone
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382.
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Experimentální: Concomitant +Mixed
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
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Experimentální: Concomitant +MF59-eH5N1
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
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Experimentální: Mixed
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
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Experimentální: Mixed and mixed
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
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Experimentální: Mixed+MF59-eH5N1
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
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Experimentální: MF59-eH5N1+eTIV_a
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
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Experimentální: eTIV_a+MF59-eH5N1
1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
Časové okno: 21 days after second and third vaccinations (day 43 and day 403)
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Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area ≤4 mm^2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm^2 for SRH). Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. |
21 days after second and third vaccinations (day 43 and day 403)
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Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine
Časové okno: 21 days after second and third vaccinations (day 22 and day 43)
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Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals.
GMR was calculated as 21 days after second and third vaccinations over day 1.
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21 days after second and third vaccinations (day 22 and day 43)
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Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)
Časové okno: 21 days after second vaccination (day 43)
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seroconversion: negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. |
21 days after second vaccination (day 43)
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Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)
Časové okno: 21 days after second and third vaccinations (day 43 and day 403)
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seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. |
21 days after second and third vaccinations (day 43 and day 403)
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Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)
Časové okno: 21 days after second and third vaccinations (day 43 and day 403)
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seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. |
21 days after second and third vaccinations (day 43 and day 403)
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Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)
Časové okno: 21 days after second vaccination (day 43)
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For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals.
GMR was calculated over day 1.
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21 days after second vaccination (day 43)
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Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)
Časové okno: 21 days after second and third vaccinations (day 43 and day 403)
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For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals.
GMR was calculated over day 1.
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21 days after second and third vaccinations (day 43 and day 403)
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Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)
Časové okno: 21 days after second and third vaccinations (day 43 and day 403)
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For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals.
GMR was calculated over day 1.
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21 days after second and third vaccinations (day 43 and day 403)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Časové okno: 21 days after second and third vaccinations (day 43 and day 403)
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The evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1 influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV_a influenza vaccine.
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21 days after second and third vaccinations (day 43 and day 403)
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Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Časové okno: 21 days after booster vaccination (day 403)
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Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤ 4 mm^2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in SRH area; Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2. The number of subjects achieving seroconversion or significant increase and seroprotection were calculated at day 382. |
21 days after booster vaccination (day 403)
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Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Časové okno: 21 days after booster vaccination (day 403)
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For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals.
GMR was calculated over day 382 for all time points for the booster dose.
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21 days after booster vaccination (day 403)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Novartis Drug Information Services +1 800 244 7668, Novartis
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Lopez P, Caicedo Y, Sierra A, Tilman S, Banzhoff A, Clemens R. Combined, concurrent, and sequential administration of seasonal influenza and MF59-adjuvanted A/H5N1 vaccines: a phase II randomized, controlled trial of immunogenicity and safety in healthy adults. J Infect Dis. 2011 Jun 15;203(12):1719-28. doi: 10.1093/infdis/jir191.
- Lopez P, Caicedo Y, Sierra A, Tilman S, Clemens R, Banzhoff A. Combined administration of MF59-adjuvanted A/H5N1 prepandemic and seasonal influenza vaccines: long-term antibody persistence and robust booster responses 1 year after a one-dose priming schedule. Clin Vaccine Immunol. 2013 May;20(5):753-8. doi: 10.1128/CVI.00626-12. Epub 2013 Mar 27.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2007
Primární dokončení (Aktuální)
1. prosince 2008
Dokončení studie (Aktuální)
1. prosince 2008
Termíny zápisu do studia
První předloženo
31. května 2007
První předloženo, které splnilo kritéria kontroly kvality
31. května 2007
První zveřejněno (Odhad)
1. června 2007
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
3. února 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
31. prosince 2013
Naposledy ověřeno
1. prosince 2013
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- V87P5
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