A Randomized, Open-label, Parallel Design Study to Compare the Immunogenicity of Simultaneous Administration Versus Sequential Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody.
研究概览
简要总结
The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown. The purpose of present study is to compare the immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine with that of separate administration.
详细描述
The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown. We compare the immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine with that of separate administration.
162 Participants are randomly assigned to one of the two study groups; Simultaneous administration group: receive injections of pneumococcal vaccine and influenza vaccine simultaneously.
Sequential administration group: receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
We compare the immunogenicity of the two groups.
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
- 否
入选标准
- •adults aged ≧65 years who had never received pneumococcal vaccine and quadrivalent influenza vaccine of 2015/2016 season
排除标准
- •a sensitivity to pneumococcal and influenza vaccine
- •received other inactivated vaccine within 14 days
- •received other live vaccine within 28 days
- •the presence of conditions known to impair pneumococcal vaccine response
- •having malignant disease
- •taking oral corticosteroids or immunosuppressive agent
- •history of splenectomy
- •history of an acute febrile illness or signs of severe acute illness at the time of vaccination
- •other inappropriate condition to receive vaccination
- •suffering an acute illness requiring antibiotics or steroids within the past month
- •not expected to survive 12 months were also excluded
结局指标
主要结局
The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody.
时间窗: 1month after the dose of PPV23
The primary endpoint was the number of patients with positive antibody responses (≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination) in serotype 23F of the pneumococcal antibody.
次要结局
- The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.(4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2))
- The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.(4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2))
- The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)(Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2))
研究者
Kei Nakashima
Assistant Chief, Department of Pulmonary Medicine
Kameda Medical Center