Evaluation on the Persistence of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell), Combined Live Attenuated Measles, Mumps and Rubella Vaccine and Freeze-dried Live Attenuated Hepatitis A Vaccine in Chinese Children: Up to 5 Years of Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- seropositive rates of antibodies against poliovirus
研究概览
简要总结
This study evaluated the antibody persistence of Chinese children five years after they received four doses of sIPV, two doses of MMR vaccine and one dose of HepA-L vaccine.
详细描述
This is a follow-up study of several previous clinical trials (A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis Vaccine (DTaP) and Measles, Moms and Rubella Vaccine (MMR) : NCT04054882, NCT04638985; A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA): NCT04053010, NCT04636827). Five years after vaccination with sIPV, MMR or HepA-L, blood samples were collected from the followed-up children to assess the antibody levels and seropositive rates against polio, measles, rubella, mumps and hepatitis A. This study was conducted in six provinces of China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in the NCT04638985 or NCT04636827, and who have completed the vaccination of designated batch numbers of sIPV, MMR or HepA-L vaccines;
- •The time window from the day of enrollment to the date when the participants received the fourth dose of sIPV vaccine, the second dose of MMR vaccine, or the first dose of HepA-L vaccine was 60 to 66 months.
- •The informed consent form shall be signed by the participant or his/her legal guardian and dated.
排除标准
- 未提供
研究组 & 干预措施
5 years of follow-up group
All the children who met the protocol criteria and had been five years since their last doses of sIPV, MMR or HepA-L were included.
结局指标
主要结局
seropositive rates of antibodies against poliovirus
时间窗: 5 years after the four doses of sIPV immunization
The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus 5 years after the four doses of sIPV immunization.
seropositive rates of antibodies against measles, rubella, mumps
时间窗: 5 years after the two doses of MMR immunization
The percentage of participants with positive antibody against measles, rubella, mumps 5 years after the two doses of MMR immunization.
seropositive rates of antibodies against hepatitis A
时间窗: 5 years after the one doses of HepA-L immunization
The percentage of participants with positive antibody against hepatitis A 5 years after the one doses of HepA-L immunization.
次要结局
- GMTs of antibodies against poliovirus(5 years after the four doses of sIPV immunization)
- GMCs of antibodies against measles, rubella, mumps(5 years after the two doses of MMR immunization)
- GMCs of antibodies against hepatitis A(5 years after the one doses of HepA-L immunization)