Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
研究概览
简要总结
The aim of the study was to assess the immunogenicity and safety of Fluzone Quadrivalent influenza vaccine Southern Hemisphere (SH) 2015 formulation in participants aged 18 to 60 years as well as in participants 61 years or older.
The objectives were:
- To evaluate the compliance, in terms of immunogenicity, of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation with the requirements of the European Medicines Agency (EMA) Note for guidance (NfG) CPMP/BWP/214/96
- To describe the immunogenicity of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation
- To describe the safety of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation
详细描述
All participants received 1 intramuscular dose of Fluzone Quadrivalent vaccine at the first visit.
Immunogenicity and safety were assessed in all participants. Adverse events (AE) defined in EMA NfG CPMP/BWP/214/96 were collected for 3 days after vaccination, solicited AE pre-listed in the diary card were collected for 7 days after vaccination, unsolicited AEs were collected for 21 days after vaccination, and serious adverse event (SAE) information was collected throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Participants were >= 18 years of age on the day of inclusion .
- •Informed consent form had been signed and dated.
- •Able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •History of serious adverse reaction to any influenza vaccine.
- •Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit
- •Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study.
- •Self-reported thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
- •Vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or a flu vaccination campaign.
- •Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information) .
- •Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
- •Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
- •Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 3 weeks after vaccination).
- •Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
- •Personal history of Guillain-Barré syndrome.
- •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).
- •Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion .
- •Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the participant. (No screening procedures were implemented.)
- •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- •Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
- •Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38°C) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •Identified as an Investigator or employee of an Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of an Investigator or employee with direct involvement in the proposed study.
研究组 & 干预措施
Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years
Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
干预措施: Fluzone Quadrivalent Influenza Vaccine (Biological)
Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
干预措施: Fluzone Quadrivalent Influenza Vaccine (Biological)
结局指标
主要结局
Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
时间窗: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Anti-influenza antibodies were measured using hemagglutination-inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroprotection was defined as an antibody titer \>=40 (1/dilution \[dil\]) at pre-vaccination and post-vaccination.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
时间窗: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Anti-influenza antibodies were measured using a HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
时间窗: Day 0 (pre-vaccination), Day 21 (Post-vaccination)
Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Geometric mean titer ratio was calculated as geometric mean titer at Day 21 divided by geometric mean titer at day 0 for each specified group.
Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
时间窗: 21 days post-vaccination
Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) and a post-vaccination titer \>= 40 (1/dil). Significant increase was defined as a pre-vaccination titer \>= 10 (1/dil) and \>= 4-fold increase in post vaccination titer. Number of participants with seroconversion or significant increase to Influenza vaccine antigens were reported.
Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance
时间窗: Within 3 days after vaccination
Solicited reactions listed in the CHMP note for guidance included: injection site induration \>= 50 mm for at least 4 consecutive days , injection site ecchymosis, temperature \> 38.0°C for at least one day, malaise, and shivering.
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
时间窗: Within 7 days after vaccination
A solicited reaction is an adverse event (AE) that is pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema, swelling, induration, and ecchymosis (Grade 1: \>=25 mm to \<= 50 mm, Grade 2: \>=51 to \<=100 mm, Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius (°C) to \<=38.4°C, Grade 2: \>=38.5°C to \<=38.9 °C, Grade 3: \>= 39°C), headache, malaise, myalgia, and shivering (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.
次要结局
未报告次要终点