Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
2. listopadu 2015 aktualizováno: Novartis Vaccines
A Phase III, Stratified, Randomized, Double-Blind, Multicenter, NonInferiority Study to Evaluate the Safety and Immunogenicity of a Cell-based Quadrivalent Subunit Influenza Virus Vaccine and Cell-based Trivalent Subunit Influenza Virus Vaccines in Adults Ages ≥18 Years of Age
Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
2680
Fáze
- Fáze 3
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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Alabama
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Huntsville, Alabama, Spojené státy, 35802
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Arizona
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Phoenix, Arizona, Spojené státy, 85050
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California
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Anaheim, California, Spojené státy, 92801
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San Diego, California, Spojené státy, 92108
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Florida
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Coral Gables, Florida, Spojené státy, 33134
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Hollywood, Florida, Spojené státy, 33024
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Melbourne, Florida, Spojené státy, 32935
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South Miami, Florida, Spojené státy, 33143
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West Palm Beach, Florida, Spojené státy, 33409
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Illinois
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Peoria, Illinois, Spojené státy, 61602
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Indiana
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Mishawaka, Indiana, Spojené státy, 46545
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Iowa
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Council Bluffs, Iowa, Spojené státy, 51503
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Kansas
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Newton, Kansas, Spojené státy, 67114
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Wichita, Kansas, Spojené státy, 67207
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Wichita, Kansas, Spojené státy, 67205
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Louisiana
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Metairie, Louisiana, Spojené státy, 70006
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Maryland
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Rockville, Maryland, Spojené státy, 20850
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Minnesota
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Edina, Minnesota, Spojené státy, 55435
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Nebraska
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Bellevue, Nebraska, Spojené státy, 68005
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Omaha, Nebraska, Spojené státy, 68134
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New York
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Endwell, New York, Spojené státy, 13760
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Rochester, New York, Spojené státy, 14609
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North Carolina
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Cary, North Carolina, Spojené státy, 27518
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Charlotte, North Carolina, Spojené státy, 28209
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Raleigh, North Carolina, Spojené státy, 27609
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Wilmington, North Carolina, Spojené státy, 28401
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73112
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Rhode Island
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Warwick, Rhode Island, Spojené státy, 02886
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South Carolina
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Anderson, South Carolina, Spojené státy, 29621
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Mt. Pleasant, South Carolina, Spojené státy, 29464
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South Dakota
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Dakota Dunes, South Dakota, Spojené státy, 57049
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Texas
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Austin, Texas, Spojené státy, 78705
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Austin, Texas, Spojené státy, 78745
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Dallas, Texas, Spojené státy, 75231
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Fort Worth, Texas, Spojené státy, 76135
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San Angelo, Texas, Spojené státy, 76904
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Utah
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Salt Lake City, Utah, Spojené státy, 84121
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Salt Lake City, Utah, Spojené státy, 84109
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Salt Lake City, Utah, Spojené státy, 84124
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South Jordan, Utah, Spojené státy, 84095
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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 a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Male or female ages 18 years and older.
- Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up.
Exclusion Criteria:
- Individuals recently vaccinated against influenza
- Subjects with contraindications to receive influenza vaccine
- Please contact the site for additional eligibility criteria
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: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: QIVc
Influenza vaccine
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Novartis Investigational Quadrivalent Vaccine
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Aktivní komparátor: TIV1c
Influenza vaccine
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Licensed Influenza Vaccine
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Aktivní komparátor: TIV2c
Influenza vaccine
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Novartis Investigational Vaccine
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
Časové okno: Three weeks post vaccination (Day 22)
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Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5. |
Three weeks post vaccination (Day 22)
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2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
Časové okno: Three weeks post vaccination (Day 22)
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Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer
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Three weeks post vaccination (Day 22)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
Časové okno: Three weeks post vaccination (Day 22)
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Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30%
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Three weeks post vaccination (Day 22)
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4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
Časové okno: Three weeks post vaccination (Day 22)
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Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60%
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Three weeks post vaccination (Day 22)
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5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Časové okno: Three weeks post vaccination (Day 22)
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Immunogenicity was measured as the geometric mean ratio (GMR).
The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is >2.5 and that for ≥ 61 years age group is >2.0
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Three weeks post vaccination (Day 22)
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6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Časové okno: Three weeks post vaccination (Day 22)
|
Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is >40% and that for ≥ 61 years age group is >30%
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Three weeks post vaccination (Day 22)
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7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Časové okno: Three weeks post vaccination (Day 22)
|
Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is >70% and that for ≥ 61 years age group is >60%
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Three weeks post vaccination (Day 22)
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8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain
Časové okno: Three weeks post vaccination (Day 22)
|
Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1. |
Three weeks post vaccination (Day 22)
|
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9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain
Časové okno: Three weeks post vaccination (Day 22)
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Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points
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Three weeks post vaccination (Day 22)
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10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain
Časové okno: Three weeks post vaccination (Day 22)
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Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1 |
Three weeks post vaccination (Day 22)
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11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain
Časové okno: Three weeks post vaccination (Day 22)
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Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points
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Three weeks post vaccination (Day 22)
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12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Časové okno: Day 1 to 7 post vaccination
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Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)
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Day 1 to 7 post vaccination
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13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Časové okno: Day 1 to 181 post vaccination
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Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)
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Day 1 to 181 post vaccination
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
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. listopadu 2013
Primární dokončení (Aktuální)
1. července 2014
Dokončení studie (Aktuální)
1. července 2014
Termíny zápisu do studia
První předloženo
7. listopadu 2013
První předloženo, které splnilo kritéria kontroly kvality
18. listopadu 2013
První zveřejněno (Odhad)
25. listopadu 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
10. prosince 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
2. listopadu 2015
Naposledy ověřeno
1. listopadu 2015
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- V130_01
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .