A PHASE 1/2, RANDOMIZED, DOUBLE-BLIND TRIAL OF THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 18 YEARS OF AGE AND OLDER
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,710
- 试验地点
- 32
- 主要终点
- Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
研究概览
简要总结
The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease.
This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulations) or 20vPnC (Prevnar 20) as a single shot given into the upper arm muscle.
Stage 2 will begin after participants have completed Stage 1, and a pneumococcal vaccine candidate has been decided.
Stage 2 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20). The vaccines will be given as a single shot into the upper arm muscle.
Stage 3 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or a licensed pneumococcal comparator vaccine. The vaccines will be given as a single shot into the upper arm muscle.
Stage 4 is seeking participants who are adults 50 years of age and older. The participants will receive either one of three pneumococcal vaccine candidates or one of two licensed pneumococcal comparator vaccines. The vaccines will be given as a single shot into the upper arm muscle.
Participants will take part in this study for about 6 months for Stage 1, Stage 3, and Stage 4 and 12 months for Stage 2. During this time participants will have from 2 to 4 clinic visits and 1 phone visit. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these clinic visits.
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)
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
- •Male or female participants ≥18 to<50 years of age (Stage 1) and ≥50 years of age (Stage 2, Stage 3, and Stage 4) at the time of consent
- •Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
- •Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children
- •Phase 1 (Stage 1): Adults 18 through 49 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve)
- •Phase 2 (Stages 2, 3, and 4): Adults ≥50 through 64 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve) and adults 65 years of age and older with either no history of ever receiving a pneumococcal vaccine or who received PPSV23 >5 years prior to the first vaccination in this study (ie, experienced)
排除标准
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
- •Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
- •Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
- •Known or suspected immunodeficiency or other conditions associated with immunosuppression
- •Planned receipt of any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
- •Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention
研究组 & 干预措施
Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4).
干预措施: Multivalent Pneumococcal Vaccine - Formulation 2 (Biological)
Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC)
Participants to receive a single injection of 20vPnC.
干预措施: 20-valent pneumococcal conjugate vaccine (20vPnC) (Biological)
Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4.
干预措施: Multivalent Pneumococcal Vaccine - Formulation 4 (Biological)
Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3.
干预措施: Multivalent Pneumococcal Vaccine - Formulation 3 (Biological)
Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4).
干预措施: Multivalent Pneumococcal Vaccine - Formulation 1 (Biological)
Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine
Participants to receive a single injection of a licensed pneumococcal comparator vaccine.
干预措施: Licensed pneumococcal comparator vaccine (Biological)
结局指标
主要结局
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
时间窗: 1 month
Adverse events occurring within 1 month after vaccination
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
时间窗: 6 months
SAEs occurring within 6 months after vaccination
Percentage of participants reporting prespecified systemic events within 7 days after vaccination
时间窗: 7 days
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination
Percentage of participants reporting prespecified local reactions within 7 days after vaccination
时间窗: 7 days
Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination
Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination
时间窗: 12 months
Related SAEs occurring through 12 months after vaccination
次要结局
- Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)(1 month after vaccination)