Safety and Immunogenicity Trial Among Adults Administered Quadrivalent Influenza Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 739
- 试验地点
- 12
- 主要终点
- Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.
研究概览
简要总结
The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the investigational TIV containing the alternate B strain in adult subjects.
Primary Objective:
- To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among subjects 65 years of age and older
Observational Objective:
- To describe the safety profiles of TIV among subjects 18 years of age and older and QIV in subjects 65 years and older, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.
详细描述
All participants will receive a single dose of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 18 years of age or older on the day of inclusion.
- •Informed consent form (ICF) has been signed and dated.
- •Able to attend all scheduled visits and to comply with all trial procedures.
- •For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks post-vaccination.
排除标准
- •Known pregnancy, or a positive urine pregnancy test.
- •Currently breastfeeding a child.
- •History of serious adverse reaction to any influenza vaccine.
- •Receipt of any vaccine in the 4 weeks preceding the trial vaccination.
- •Planned receipt of any vaccine between Visit 1 and Visit
- •Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first study vaccination or during the course of the study.
- •Receipt of any influenza vaccine since 01 August 2010 (including 2009 H1N1 monovalent vaccine).
- •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances.
- •Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
- •Thrombocytopenia, bleeding disorder, or receipt of anticoagulants contraindicating intramuscular vaccination.
- •Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
- •Personal history of Guillain-Barré Syndrome (GBS).
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- •Any chronic illness that, in the opinion of the Investigator, is not well controlled or that may interfere with trial conduct or completion or with assessment of adverse events.
- •Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- •Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
- •Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
研究组 & 干预措施
Group 1: Investigational Quadrivalent Influenza Vaccine
Participants will receive a dose of Investigational Quadrivalent Inactivated Influenza Vaccine
干预措施: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative (Biological)
Group 2: Investigational Trivalent Influenza Vaccine
Participants will receive a dose of Investigational Trivalent Inactivated Influenza Vaccine
干预措施: Investigational Trivalent Inactivated Influenza Vaccine, No Preservative (Biological)
Group 3: Licensed 2010-2011 Trivalent Influenza Vaccine
Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine
干预措施: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative (Biological)
Group 4: Licensed 2010-2011 Trivalent Influenza Vaccine
Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine
干预措施: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative (Biological)
结局指标
主要结局
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.
时间窗: Day 21 post-vaccination
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older
时间窗: Day 0 and Day 21 post-vaccination
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.
时间窗: Day 21 post-vaccination
Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
次要结局
未报告次要终点