Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of sIPV Co-administered With MMR and HepA-I.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 889
- 试验地点
- 1
- 主要终点
- seroconversion rates (SCRs) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)
研究概览
简要总结
This is an Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of Sabin Strain Inactivated Poliovirus Vaccine (Vero cell) (sIPV) Co-administered with Measles, Mumps, Rubella (MMR) Combined Live Attenuated Vaccine and Inactivated Hepatitis A (Hep-A) Vaccine.
详细描述
The trial plans to enroll 960 infants aged 18 months (+4 months) who had completed three primary doses of sIPV vaccine and were assigned in a 2:2:2:1:1 ratio to four groups including trial group 1, trial group 2, control group 1, control group 2, control group 2, with informed consent from the participant's guardian. Trial group 1 receive one dose of sIPV co-administered with one dose of MMR vaccine. Trial group 2 receive one dose of sIPV co-administered with one dose of inactivated hepatitis A vaccine. Control group 1 receive one dose of sIPV, control group 2 receive one dose of MMR vaccine, and control group 3 receive one dose of inactivated hepatitis A vaccine. About 3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination for antibody detection. Immediate reactions will be observed for 30 minutes after vaccination, and adverse events occured from 0 to day 30 after vaccination will be collected.
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
- 18 Months 至 22 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) healthy toddlers aged 18 months (+4 months);
- •(2) completed three doses of sIPV primary immunization;
- •(3) completed one dose of MMR vaccination;
- •(4) able to provide proof of vaccination;
- •(5) able to provide legal proof of identity;
- •(6) The guardians of the participants were able to understand and agree to sign the informed consent.
排除标准
- •(1) a history of vaccination with a polio-containing vaccine component in addition to three sIPV primary doses, according to the vaccination certificate;
- •(2) have received a second dose of MMR vaccine or a vaccine containing a vaccine for measles, mumps or rubella, or hepatitis A vaccine (inactivated or attenuated), according to the vaccination certificate;
- •(3) previous history of polio or measles or mumps or rubella or hepatitis A;
- •(4) known severe allergy to the vaccine or vaccine components, such as urticaria, dyspnea, angioedema;
- •(5) severe congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- •(6) with autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, asplenia, functional asplenia, and HIV infection);
- •(7) abnormal coagulation function (such as coagulation factor deficiency, platelet abnormality), or obvious bleeding, hematoma, or ecchymosis after previous intramuscular injection or venipuncture;
- •(8) have/have had a serious neurological disease (e.g., encephalopathy, epilepsy, convulsions [other than febrile convulsions]) or psychosis, a family history of neurological disease or psychosis;
- •(9) receiving immunosuppressive or other immunomodulatory therapy, cytotoxic therapy within the past 6 months, or planning to receive such treatment during the trial;
- •(10) have received an immune globulin or other blood products within the past 6 months or plan to receive such treatment during the trial;
- •(11) receipt of other investigational vaccines within 30 days before vaccination with the investigational vaccines;
- •(12) receipt of live attenuated vaccine within 28 days before vaccination with the investigational vaccine;
- •(13) receipt of subunit or inactivated vaccine within 7 days before vaccination with the investigational vaccine;
- •(14) acute diseases or acute episodes of chronic diseases within the past 7 days;
- •(15) Axillary temperature >37.0℃ if fever occurred before vaccination;
- •(16) which are unsuitable for participation in the clinical trial as judged by the investigators.
研究组 & 干预措施
Control group 2
vaccination with MMR
干预措施: MMR (Biological)
Trial group 1
vaccination with sIPV+MMR
干预措施: sIPV (Biological)
Trial group 1
vaccination with sIPV+MMR
干预措施: MMR (Biological)
Trial group 2
vaccination with sIPV+HepA-I
干预措施: sIPV (Biological)
Trial group 2
vaccination with sIPV+HepA-I
干预措施: HepA-I (Biological)
Control group 1
vaccination with sIPV
干预措施: sIPV (Biological)
Control group 3
vaccination with HepA-I
干预措施: HepA-I (Biological)
结局指标
主要结局
seroconversion rates (SCRs) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)
时间窗: 30 days
-The SCRs of neutralizing antibody against different poliovirus serotypes (Type I, II and III) at day 30 after sIPV vaccination.
SCRs of anti-rubella IgG antibodies
时间窗: 30 days
SCRs of anti-rubella IgG antibodies 30 days after vaccination
SCRs of anti-mumps IgG antibodies
时间窗: 30 days
SCRs of anti-mumps IgG antibodies 30 days after vaccination
SCRs of anti-hepatitis A IgG antibodies
时间窗: 30 days
SCRs of anti-hepatitis A antibodies 30 days after vaccination
SCRs of anti-meascles IgG antibodies
时间窗: 30 days
SCRs of anti-measles IgG antibodies 30 days after vaccination
次要结局
- SPRs and GMC of anti-mumps virus IgG antibodies(30 days)
- SPRs and GMC of anti- hepatitis A virus IgG antibodies(30 days)
- Geometric Mean Titer (GMT) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)(30 days)
- Seropositivity rates (SPRs) and GMC of anti-measles virus IgG antibodies(30 days)
- SPRs and GMC of anti-rubella virus IgG antibodies(30 days)
- - SPRs of neutralizing antibodies against different poliovirus serotypes (Type I, II and III)(30 days)
- - Incidence of adverse reactions (ARs)(30 days)
- - Incidence of serious adverse events (SAEs)(30 days)