Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
2 november 2015 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
2680
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Alabama
-
Huntsville, Alabama, Förenta staterna, 35802
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85050
-
-
California
-
Anaheim, California, Förenta staterna, 92801
-
San Diego, California, Förenta staterna, 92108
-
-
Florida
-
Coral Gables, Florida, Förenta staterna, 33134
-
Hollywood, Florida, Förenta staterna, 33024
-
Melbourne, Florida, Förenta staterna, 32935
-
South Miami, Florida, Förenta staterna, 33143
-
West Palm Beach, Florida, Förenta staterna, 33409
-
-
Illinois
-
Peoria, Illinois, Förenta staterna, 61602
-
-
Indiana
-
Mishawaka, Indiana, Förenta staterna, 46545
-
-
Iowa
-
Council Bluffs, Iowa, Förenta staterna, 51503
-
-
Kansas
-
Newton, Kansas, Förenta staterna, 67114
-
Wichita, Kansas, Förenta staterna, 67207
-
Wichita, Kansas, Förenta staterna, 67205
-
-
Louisiana
-
Metairie, Louisiana, Förenta staterna, 70006
-
-
Maryland
-
Rockville, Maryland, Förenta staterna, 20850
-
-
Minnesota
-
Edina, Minnesota, Förenta staterna, 55435
-
-
Nebraska
-
Bellevue, Nebraska, Förenta staterna, 68005
-
Omaha, Nebraska, Förenta staterna, 68134
-
-
New York
-
Endwell, New York, Förenta staterna, 13760
-
Rochester, New York, Förenta staterna, 14609
-
-
North Carolina
-
Cary, North Carolina, Förenta staterna, 27518
-
Charlotte, North Carolina, Förenta staterna, 28209
-
Raleigh, North Carolina, Förenta staterna, 27609
-
Wilmington, North Carolina, Förenta staterna, 28401
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Förenta staterna, 73112
-
-
Rhode Island
-
Warwick, Rhode Island, Förenta staterna, 02886
-
-
South Carolina
-
Anderson, South Carolina, Förenta staterna, 29621
-
Mt. Pleasant, South Carolina, Förenta staterna, 29464
-
-
South Dakota
-
Dakota Dunes, South Dakota, Förenta staterna, 57049
-
-
Texas
-
Austin, Texas, Förenta staterna, 78705
-
Austin, Texas, Förenta staterna, 78745
-
Dallas, Texas, Förenta staterna, 75231
-
Fort Worth, Texas, Förenta staterna, 76135
-
San Angelo, Texas, Förenta staterna, 76904
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84121
-
Salt Lake City, Utah, Förenta staterna, 84109
-
Salt Lake City, Utah, Förenta staterna, 84124
-
South Jordan, Utah, Förenta staterna, 84095
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: QIVc
Influenza vaccine
|
Novartis Investigational Quadrivalent Vaccine
|
|
Aktiv komparator: TIV1c
Influenza vaccine
|
Licensed Influenza Vaccine
|
|
Aktiv komparator: TIV2c
Influenza vaccine
|
Novartis Investigational Vaccine
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2013
Primärt slutförande (Faktisk)
1 juli 2014
Avslutad studie (Faktisk)
1 juli 2014
Studieregistreringsdatum
Först inskickad
7 november 2013
Först inskickad som uppfyllde QC-kriterierna
18 november 2013
Första postat (Uppskatta)
25 november 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 december 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 november 2015
Senast verifierad
1 november 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- V130_01
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .