A PHASE 3, SINGLE-ARM, MULTICENTER TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS ≥18 YEARS OF AGE IN INDIA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 405
- 试验地点
- 7
- 主要终点
- Percentage of Participants With Local Reactions Within 7 Days After Vaccination
研究概览
简要总结
The purpose of this study is to learn about the safety and immune response of 20vPnC in adults in India.
This study is seeking participants who:
- are generally healthy adults of 18 years or older.
- have not received pneumococcal vaccine.
The study will have 2 groups based on age. One group will have particpants between 18 to 49 years of age. The other group will have participants of 50 years or older.
Participants will take part in the study for about one month which includes two visits to the study clinic. Participants will receive a single dose of study vaccine (20vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month.
The study team will ask questions about the participant's health and blood samples will be taken in a subset of participants during the visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Generally healthy participants ≥18 years of age at the time of consent.
排除标准
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 20vPnC, or to any other diphtheria toxoid-containing vaccine.
- •Known or suspected immune deficiency or suppression.
- •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.
- •Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation.
研究组 & 干预措施
20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine (20vPnC)
干预措施: 20-valent pneumococcal conjugate vaccine (Biological)
结局指标
主要结局
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
时间窗: Day 1 to Day 7 after vaccination
Local reactions (redness, swelling, and injection site pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units where 1 caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than \[\>\]2.0 to 5.0 cm), moderate (\>5.0 to 10.0cm) and severe (\>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
时间窗: Day 1 to Day 7 after vaccination
Systemic events included: fever, fatigue, headache, joint pain and muscle pain. Fever was defined as an oral temperature of more than or equal to (\>=)38.0 degree Celsius (C) and was classified as \>=38.0 degree C, \>=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, joint pain and muscle pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination
时间窗: From vaccination on Day 1 up to 1 Month after vaccination
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination
时间窗: From vaccination on Day 1 up to 1 Month after vaccination
An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or 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.
次要结局
- Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination(From before vaccination to 1 Month after vaccination)