Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
maanantai 2. marraskuuta 2015 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
2680
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Alabama
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Huntsville, Alabama, Yhdysvallat, 35802
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Arizona
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Phoenix, Arizona, Yhdysvallat, 85050
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California
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Anaheim, California, Yhdysvallat, 92801
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San Diego, California, Yhdysvallat, 92108
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Florida
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Coral Gables, Florida, Yhdysvallat, 33134
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Hollywood, Florida, Yhdysvallat, 33024
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Melbourne, Florida, Yhdysvallat, 32935
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South Miami, Florida, Yhdysvallat, 33143
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West Palm Beach, Florida, Yhdysvallat, 33409
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Illinois
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Peoria, Illinois, Yhdysvallat, 61602
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Indiana
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Mishawaka, Indiana, Yhdysvallat, 46545
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Iowa
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Council Bluffs, Iowa, Yhdysvallat, 51503
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Kansas
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Newton, Kansas, Yhdysvallat, 67114
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Wichita, Kansas, Yhdysvallat, 67207
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Wichita, Kansas, Yhdysvallat, 67205
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Louisiana
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Metairie, Louisiana, Yhdysvallat, 70006
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Maryland
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Rockville, Maryland, Yhdysvallat, 20850
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Minnesota
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Edina, Minnesota, Yhdysvallat, 55435
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Nebraska
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Bellevue, Nebraska, Yhdysvallat, 68005
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Omaha, Nebraska, Yhdysvallat, 68134
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New York
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Endwell, New York, Yhdysvallat, 13760
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Rochester, New York, Yhdysvallat, 14609
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North Carolina
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Cary, North Carolina, Yhdysvallat, 27518
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Charlotte, North Carolina, Yhdysvallat, 28209
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Raleigh, North Carolina, Yhdysvallat, 27609
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Wilmington, North Carolina, Yhdysvallat, 28401
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat, 73112
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Rhode Island
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Warwick, Rhode Island, Yhdysvallat, 02886
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South Carolina
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Anderson, South Carolina, Yhdysvallat, 29621
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Mt. Pleasant, South Carolina, Yhdysvallat, 29464
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South Dakota
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Dakota Dunes, South Dakota, Yhdysvallat, 57049
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Texas
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Austin, Texas, Yhdysvallat, 78705
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Austin, Texas, Yhdysvallat, 78745
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Dallas, Texas, Yhdysvallat, 75231
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Fort Worth, Texas, Yhdysvallat, 76135
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San Angelo, Texas, Yhdysvallat, 76904
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Utah
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Salt Lake City, Utah, Yhdysvallat, 84121
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Salt Lake City, Utah, Yhdysvallat, 84109
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Salt Lake City, Utah, Yhdysvallat, 84124
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South Jordan, Utah, Yhdysvallat, 84095
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: QIVc
Influenza vaccine
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Novartis Investigational Quadrivalent Vaccine
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Active Comparator: TIV1c
Influenza vaccine
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Licensed Influenza Vaccine
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Active Comparator: TIV2c
Influenza vaccine
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Novartis Investigational Vaccine
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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, 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
Aikaikkuna: 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 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
Aikaikkuna: Three weeks post vaccination (Day 22)
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
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Opi tärkeimmät päivämäärät
Opiskelun aloitus
Perjantai 1. marraskuuta 2013
Ensisijainen valmistuminen (Todellinen)
Tiistai 1. heinäkuuta 2014
Opintojen valmistuminen (Todellinen)
Tiistai 1. heinäkuuta 2014
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 7. marraskuuta 2013
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 18. marraskuuta 2013
Ensimmäinen Lähetetty (Arvio)
Maanantai 25. marraskuuta 2013
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Torstai 10. joulukuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 2. marraskuuta 2015
Viimeksi vahvistettu
Sunnuntai 1. marraskuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- V130_01
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