Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
2. november 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
2680
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Huntsville, Alabama, Forente stater, 35802
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Arizona
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Phoenix, Arizona, Forente stater, 85050
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California
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Anaheim, California, Forente stater, 92801
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San Diego, California, Forente stater, 92108
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Florida
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Coral Gables, Florida, Forente stater, 33134
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Hollywood, Florida, Forente stater, 33024
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Melbourne, Florida, Forente stater, 32935
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South Miami, Florida, Forente stater, 33143
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West Palm Beach, Florida, Forente stater, 33409
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Illinois
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Peoria, Illinois, Forente stater, 61602
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Indiana
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Mishawaka, Indiana, Forente stater, 46545
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Iowa
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Council Bluffs, Iowa, Forente stater, 51503
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Kansas
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Newton, Kansas, Forente stater, 67114
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Wichita, Kansas, Forente stater, 67207
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Wichita, Kansas, Forente stater, 67205
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Louisiana
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Metairie, Louisiana, Forente stater, 70006
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Maryland
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Rockville, Maryland, Forente stater, 20850
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Minnesota
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Edina, Minnesota, Forente stater, 55435
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Nebraska
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Bellevue, Nebraska, Forente stater, 68005
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Omaha, Nebraska, Forente stater, 68134
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New York
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Endwell, New York, Forente stater, 13760
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Rochester, New York, Forente stater, 14609
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North Carolina
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Cary, North Carolina, Forente stater, 27518
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Charlotte, North Carolina, Forente stater, 28209
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Raleigh, North Carolina, Forente stater, 27609
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Wilmington, North Carolina, Forente stater, 28401
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73112
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Rhode Island
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Warwick, Rhode Island, Forente stater, 02886
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South Carolina
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Anderson, South Carolina, Forente stater, 29621
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Mt. Pleasant, South Carolina, Forente stater, 29464
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South Dakota
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Dakota Dunes, South Dakota, Forente stater, 57049
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Texas
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Austin, Texas, Forente stater, 78705
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Austin, Texas, Forente stater, 78745
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Dallas, Texas, Forente stater, 75231
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Fort Worth, Texas, Forente stater, 76135
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San Angelo, Texas, Forente stater, 76904
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Utah
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Salt Lake City, Utah, Forente stater, 84121
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Salt Lake City, Utah, Forente stater, 84109
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Salt Lake City, Utah, Forente stater, 84124
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South Jordan, Utah, Forente stater, 84095
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: QIVc
Influenza vaccine
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Novartis Investigational Quadrivalent Vaccine
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Aktiv komparator: TIV1c
Influenza vaccine
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Licensed Influenza Vaccine
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Aktiv komparator: TIV2c
Influenza vaccine
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Novartis Investigational Vaccine
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
Tidsramme: 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
Tidsramme: 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
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Three weeks post vaccination (Day 22)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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
Tidsramme: 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%
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2013
Primær fullføring (Faktiske)
1. juli 2014
Studiet fullført (Faktiske)
1. juli 2014
Datoer for studieregistrering
Først innsendt
7. november 2013
Først innsendt som oppfylte QC-kriteriene
18. november 2013
Først lagt ut (Anslag)
25. november 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2015
Sist bekreftet
1. november 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- V130_01
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