Safety and Immunogenicity of Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years: a Four-arm, Double-blind, Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 256
- 主要终点
- Immunogenicity
研究概览
简要总结
Vaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults aged over 60 or 65 years (depending local guidelines) who have never received a pneumococcal vaccine or whose previous vaccination history is unknown. Given their wide application, co-administration of pneumococcal and Covid-19 vaccines may support broad population-wide coverage. However, it is unclear whether the co-administration of the Novavax (NVX) vaccine and a 20-valent pneumococcal conjugate vaccine (PCV20) results in lower immunogenicity than the administration of either alone.
The investigators will thus conduct a 4-four arm study with the following treatments: NVX plus placebo (NVX arm), PCV20 plus placebo group (PCV20 arm), NVX plus PCV20 (Combination arm), and placebo plus placebo group (Placebo arm). Vaccines and/or placebo will be administered as single doses, given as intramuscular injections on Day 1 (one in each shoulder). Subjects will be randomly assigned to one of the four arms.
The outcome will be the antibody levels after 28 days.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 60 years or older
- •Males and females
- •Able and willing (in the investigator's opinion) to comply with all study requirements.
- •Participants, who already received three Covid-19 vaccines, of which the third was a mRNA vaccine (BNT162b2 or mRNA-1273) and at least 16 weeks ago
- •Only applicable for women: last menstrual bleeding more than one year ago
排除标准
- •Use of immunosuppressants
- •Congenital or acquired immunodeficiency (eg, history of HIV infection, hematological disease, current malignancy, or others)
- •Chronic condition that may significantly interfere with the immune response in the opinion of the investigator
- •History of Covid-19 within 16 weeks before study vaccination
- •Previous pneumococcal vaccination
- •Contraindication against any ingredient of the NVX or the PCV20 vaccine
研究组 & 干预措施
PCV20 arm
PCV20 (Apexxnar®) plus placebo
干预措施: PCV20 (Biological)
Combination arm
NVX plus PCV20
干预措施: PCV20 (Biological)
结局指标
主要结局
Immunogenicity
时间窗: Day 28
Antibody levels
次要结局
未报告次要终点
研究者
Markus Zeitlinger
Prof. Dr.
Medical University of Vienna