A PHASE 3, RANDOMIZED, DOUBLE BLIND TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF 20 VALENT PNEUMOCOCCAL CONJUGATE VACCINE WHEN COADMINISTERED WITH A BOOSTER DOSE OF BNT162b2 IN ADULTS 65 YEARS OF AGE AND OLDER
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 570
- 试验地点
- 27
- 主要终点
- Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
研究概览
简要总结
Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants ≥65 years of age at the time of consent
- •Participating or participated in Study C4591001, received 2 doses of 30 µg BNT162b2 with the second dose given ≥6 months prior to the first vaccination in this study, and have not received a third dose of BNT162b2
- •Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with preexisting stable disease
- •Adults who have no history of ever receiving a pneumococcal vaccine, or received a licensed pneumococcal vaccination ≥12 months prior to the first vaccination in this study
排除标准
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
- •Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
- •Previous clinical or microbiological diagnosis of COVID-19
- •Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
- •Previous vaccination with any coronavirus vaccine, other than those received in Study C4591001
- •Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
研究组 & 干预措施
Coadministration Group
Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit.
干预措施: 20-valent pneumococcal conjugate vaccine (20vPnC) (Biological)
20vPnC-only Group
Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit.
干预措施: 20-valent pneumococcal conjugate vaccine (20vPnC) (Biological)
20vPnC-only Group
Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit.
干预措施: Saline (Other)
BNT162b2-only Group
Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit.
干预措施: Saline (Other)
BNT162b2-only Group
Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit.
干预措施: BNT162b2 (Biological)
Coadministration Group
Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit.
干预措施: BNT162b2 (Biological)
结局指标
主要结局
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
时间窗: From day of vaccination (Day 1) up to 6 months after vaccination
A SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
时间窗: Within 7 days after vaccination
Systemic events including fever, fatigue, headache, chills, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Percentage of participants with systemic events within 7 days after vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
时间窗: Within 10 days after vaccination
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at each injection site within 10 days after vaccination and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
时间窗: From day of vaccination (Day 1) up to 1 month after vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with AEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
次要结局
- Geometric Mean Fold Rise (GMFR) of Full-Length S-Binding IgG Levels From Before Vaccination to 1 Month After Vaccination With BNT162b2(Before vaccination to 1 month after vaccination with BNT162b2)
- Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC(1 month after vaccination with 20vPnC)
- Geometric Mean Concentration (GMC) of Full-Length S-Binding Immunoglobulin G (IgG) Levels at 1 Month After Vaccination With BNT162b2(1 month after vaccination with BNT162b2)