Immunogenicity and Safety of an Influenza Vaccine Administered Concomitantly With a 13-Valent Pneumococcal Conjugate Vaccine or 23-Valent Polysaccharide Pneumococcal Vaccine in Elderly Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 4
- 主要终点
- Seroconversion rates (A/H1N1, A/H3N2, and B)
研究概览
简要总结
Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of concomitant administration in the elderly subjects.
详细描述
During the influenza vaccination period, 224 healthy elderly volunteers randomly received IIV3 given concomitantly with either PCV13 (PCV13+IIV3) or PPV23 (PPV23+IIV3) in a 1:1 ratio. Serum hemagglutination-inhibiting (HI) antibodies for IIV3 were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded prospectively in a clinical diary during a 7-day period.
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
- None
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
- •Adults aged ≥65 years who signed the informed consent
排除标准
- •Previous pneumococcal vaccine recipients
- •Egg allergy
- •History of serious adverse event after vaccination
- •Any acute disease or infection
- •History of neurological symptoms or signs
- •Impairment of immune function or immunosuppressant use
- •Bleeding diathesis
- •Fever (defined as axillary temperature ³38.0°C) within 3 days
- •History of Streptococcal pneumoniae infection within the previous 5 years
结局指标
主要结局
Seroconversion rates (A/H1N1, A/H3N2, and B)
时间窗: Change from baseline titer at 4 weeks
Seroconversion: a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of \<1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
次要结局
- GMT folds (A/H1N1, A/H3N2, and B)(Change from baseline titer at 4 weeks)
- Seroprotection rates (A/H1N1, A/H3N2, and B)(Change from baseline titer at 4 weeks)
研究者
Hee Jin Cheong
Professor
Korea University Guro Hospital