Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
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
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Alabama
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Huntsville、Alabama、アメリカ、35802
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Arizona
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Phoenix、Arizona、アメリカ、85050
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California
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Anaheim、California、アメリカ、92801
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San Diego、California、アメリカ、92108
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Florida
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Coral Gables、Florida、アメリカ、33134
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Hollywood、Florida、アメリカ、33024
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Melbourne、Florida、アメリカ、32935
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South Miami、Florida、アメリカ、33143
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West Palm Beach、Florida、アメリカ、33409
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Illinois
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Peoria、Illinois、アメリカ、61602
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Indiana
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Mishawaka、Indiana、アメリカ、46545
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Iowa
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Council Bluffs、Iowa、アメリカ、51503
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Kansas
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Newton、Kansas、アメリカ、67114
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Wichita、Kansas、アメリカ、67207
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Wichita、Kansas、アメリカ、67205
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Louisiana
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Metairie、Louisiana、アメリカ、70006
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Maryland
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Rockville、Maryland、アメリカ、20850
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Minnesota
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Edina、Minnesota、アメリカ、55435
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Nebraska
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Bellevue、Nebraska、アメリカ、68005
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Omaha、Nebraska、アメリカ、68134
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New York
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Endwell、New York、アメリカ、13760
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Rochester、New York、アメリカ、14609
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North Carolina
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Cary、North Carolina、アメリカ、27518
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Charlotte、North Carolina、アメリカ、28209
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Raleigh、North Carolina、アメリカ、27609
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Wilmington、North Carolina、アメリカ、28401
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73112
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Rhode Island
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Warwick、Rhode Island、アメリカ、02886
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South Carolina
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Anderson、South Carolina、アメリカ、29621
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Mt. Pleasant、South Carolina、アメリカ、29464
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South Dakota
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Dakota Dunes、South Dakota、アメリカ、57049
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Texas
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Austin、Texas、アメリカ、78705
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Austin、Texas、アメリカ、78745
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Dallas、Texas、アメリカ、75231
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Fort Worth、Texas、アメリカ、76135
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San Angelo、Texas、アメリカ、76904
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Utah
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Salt Lake City、Utah、アメリカ、84121
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Salt Lake City、Utah、アメリカ、84109
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Salt Lake City、Utah、アメリカ、84124
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South Jordan、Utah、アメリカ、84095
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:QIVc
Influenza vaccine
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Novartis Investigational Quadrivalent Vaccine
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アクティブコンパレータ:TIV1c
Influenza vaccine
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Licensed Influenza Vaccine
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アクティブコンパレータ:TIV2c
Influenza vaccine
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Novartis Investigational Vaccine
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
時間枠: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
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- V130_01
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
QIVcの臨床試験
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Seqirus完了インフルエンザ、ヒトバングラデシュ, ブルガリア, チェコ, エストニア, ホンジュラス, ラトビア, マレーシア, ニュージーランド, パキスタン, フィリピン, ポーランド, ルーマニア, タイ, ウクライナ, 南アフリカ
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Seqirus完了インフルエンザ、ヒトオーストラリア, エストニア, フィンランド, リトアニア, フィリピン, ポーランド, スペイン, タイ