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Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older

2. November 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

2680

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Huntsville, Alabama, Vereinigte Staaten, 35802
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85050
    • California
      • Anaheim, California, Vereinigte Staaten, 92801
      • San Diego, California, Vereinigte Staaten, 92108
    • Florida
      • Coral Gables, Florida, Vereinigte Staaten, 33134
      • Hollywood, Florida, Vereinigte Staaten, 33024
      • Melbourne, Florida, Vereinigte Staaten, 32935
      • South Miami, Florida, Vereinigte Staaten, 33143
      • West Palm Beach, Florida, Vereinigte Staaten, 33409
    • Illinois
      • Peoria, Illinois, Vereinigte Staaten, 61602
    • Indiana
      • Mishawaka, Indiana, Vereinigte Staaten, 46545
    • Iowa
      • Council Bluffs, Iowa, Vereinigte Staaten, 51503
    • Kansas
      • Newton, Kansas, Vereinigte Staaten, 67114
      • Wichita, Kansas, Vereinigte Staaten, 67207
      • Wichita, Kansas, Vereinigte Staaten, 67205
    • Louisiana
      • Metairie, Louisiana, Vereinigte Staaten, 70006
    • Maryland
      • Rockville, Maryland, Vereinigte Staaten, 20850
    • Minnesota
      • Edina, Minnesota, Vereinigte Staaten, 55435
    • Nebraska
      • Bellevue, Nebraska, Vereinigte Staaten, 68005
      • Omaha, Nebraska, Vereinigte Staaten, 68134
    • New York
      • Endwell, New York, Vereinigte Staaten, 13760
      • Rochester, New York, Vereinigte Staaten, 14609
    • North Carolina
      • Cary, North Carolina, Vereinigte Staaten, 27518
      • Charlotte, North Carolina, Vereinigte Staaten, 28209
      • Raleigh, North Carolina, Vereinigte Staaten, 27609
      • Wilmington, North Carolina, Vereinigte Staaten, 28401
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73112
    • Rhode Island
      • Warwick, Rhode Island, Vereinigte Staaten, 02886
    • South Carolina
      • Anderson, South Carolina, Vereinigte Staaten, 29621
      • Mt. Pleasant, South Carolina, Vereinigte Staaten, 29464
    • South Dakota
      • Dakota Dunes, South Dakota, Vereinigte Staaten, 57049
    • Texas
      • Austin, Texas, Vereinigte Staaten, 78705
      • Austin, Texas, Vereinigte Staaten, 78745
      • Dallas, Texas, Vereinigte Staaten, 75231
      • Fort Worth, Texas, Vereinigte Staaten, 76135
      • San Angelo, Texas, Vereinigte Staaten, 76904
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84121
      • Salt Lake City, Utah, Vereinigte Staaten, 84109
      • Salt Lake City, Utah, Vereinigte Staaten, 84124
      • South Jordan, Utah, Vereinigte Staaten, 84095

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Male or female ages 18 years and older.
  2. Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up.

Exclusion Criteria:

  1. Individuals recently vaccinated against influenza
  2. Subjects with contraindications to receive influenza vaccine
  3. Please contact the site for additional eligibility criteria

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: QIVc
Influenza vaccine
Biologisch: QIVc
Novartis Investigational Quadrivalent Vaccine
Aktiver Komparator: TIV1c
Influenza vaccine
Biologisch: TIV1c
Licensed Influenza Vaccine
Aktiver Komparator: TIV2c
Influenza vaccine
Biologisch: TIV2c
Novartis Investigational Vaccine

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
Zeitfenster: Three weeks post vaccination (Day 22)

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)
2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
Zeitfenster: Three weeks post vaccination (Day 22)
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
Three weeks post vaccination (Day 22)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
Zeitfenster: Three weeks post vaccination (Day 22)
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%
Three weeks post vaccination (Day 22)
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
Zeitfenster: 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 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%
Three weeks post vaccination (Day 22)
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
Zeitfenster: Three weeks post vaccination (Day 22)
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
Three weeks post vaccination (Day 22)
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
Zeitfenster: 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%
Three weeks post vaccination (Day 22)
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
Zeitfenster: 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%
Three weeks post vaccination (Day 22)
8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain
Zeitfenster: 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)
9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain
Zeitfenster: Three weeks post vaccination (Day 22)
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
Three weeks post vaccination (Day 22)
10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain
Zeitfenster: Three weeks post vaccination (Day 22)

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)
11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain
Zeitfenster: Three weeks post vaccination (Day 22)
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
Three weeks post vaccination (Day 22)
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Zeitfenster: Day 1 to 7 post vaccination
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)
Day 1 to 7 post vaccination
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Zeitfenster: Day 1 to 181 post vaccination
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)
Day 1 to 181 post vaccination

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Novartis Vaccines

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2013

Primärer Abschluss (Tatsächlich)

1. Juli 2014

Studienabschluss (Tatsächlich)

1. Juli 2014

Studienanmeldedaten

Zuerst eingereicht

7. November 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. November 2013

Zuerst gepostet (Schätzen)

25. November 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

10. Dezember 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2015

Zuletzt verifiziert

1. November 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • V130_01

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