Safety of Sabin Inactivated Poliovirus Vaccine in Adults, Children and Infants and Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants
- Conditions
- Poliomyelitis
- Interventions
- Biological: Experimental vaccineBiological: IPV control vaccineBiological: single-person sIPV control vaccine
- Registration Number
- NCT05386810
- Lead Sponsor
- Sinovac Biotech Co., Ltd
- Brief Summary
This study includes two parts.A clinical trial with a open-label to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml-5 doses)(hereinafter referred to as "msIPV")manufactured by Sinovac Biotech Co., Ltd. in adults, children and infants in partⅠ and a blinded,randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msIPV in 2 months old infants in partⅡ.
- Detailed Description
This study includes two stages. A clinical trial with an open-label to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml-5 doses) (hereinafter referred to as "msIPV") in adults, children and infants in stageⅠ and a blinded, randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msIPV in 2 months old infants in stage Ⅱ. A total of 1572 subjects including 24 adults aged 18-49 years,24 children aged 4 years,1524 infants aged 2 months will be enrolled.
StagesⅠ:72 healthy subjects, including 24 adults,24 children and 24 infants will be enrolled. 24 adults and 24 children will receive one dose of vaccine and 24 infants will receive 4 doses of vaccine according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months.
StagesⅡ:1500 infants aged 2 months will be randomly divided into 5 groups (Experimental Vaccine-lot 1, Experimental Vaccine-lot 2, Experimental Vaccine-lot 3,IPV control group and single-dose sIPV control group) according to the ratio of 1:1:1:1:1. Subjects in 3 experimental groups will receive 5-dose sIPV produced by Sinovac for three lots, subjects in IPV control group will receive IPV produced by Pasteur, and subjects in single-dose sIPV control group will receive single-dose sIPV produced by Sinovac. All subjects will receive 4 doses of experimental or control vaccine according to the primary immunization schedule of 0,1,2 months, one dose of booster at 18 months of age.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1572
Inclusion criteria for adult subjects :
- Healthy adults aged 18-49 days;
- Proven legal identification;
- The subject can understand and voluntarily sign the informed consent form.
Inclusion criteria for children subjects :
- Healthy children aged 4 years old;
- Subjects who have completed primary immunization with 3 doses of sIPV vaccine;
- Proven legal identification and vaccination certificate;
- The subject and/or guardian can understand and voluntarily sign the informed consent form.
Inclusion criteria for infant subjects:
- Healthy infants aged 2 months (60~89 days)
- Proven legal identification and vaccination certificate;
- The subject and/or guardian can understand and voluntarily sign the informed consent form.
Exclusion criteria for adult subjects:
- Women aged 18 to 49 years, positive urine pregnancy test, pregnant women, breastfeeding women, or planning to become pregnant within 3 months;
- Previous history of vaccination of sIPV vaccine;
- Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
- Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
- Autoimmune disease or immunodeficiency/immunosuppression;
- Thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy;
- Serious chronic diseases, serious cardiovascular diseases, hypertension that cannot be controlled by drugs (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg), diabetes, liver and kidney diseases, malignant tumors, etc;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- Medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- History of alcohol or drug abuse;
- Receipt of blood products within in the past 3 months;
- Receipt of other investigational drugs in the past 30 days;
- Receipt of attenuated live vaccines in the past 14 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
- Axillary temperature >37.0°C;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Exclusion criteria for children subjects:
- Have received 4 doses of sIPV vaccine;
- History of polio;
- Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
- Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
- Autoimmune disease or immunodeficiency/immunosuppression;
- Thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy;
- Suffering from serious cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- Medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- History of alcohol or drug abuse;
- Receipt of blood products within in the past 3 months;
- Receipt of other investigational drugs in the past 30 days;
- Receipt of attenuated live vaccines in the past 14 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
- Axillary temperature >37.0°C;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Exclusion criteria for infant subjects:
-
Previous history of vaccination of sIPV vaccine;
-
History of polio;
-
Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
-
Preterm birth babies (delivered before 37 weeks gestation), low birth weight (girls with birth weight <2300g, boy with birth weight<2500 g);
-
History of dystocia, asphyxia and nervous system damage at birth;
- Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
-
Autoimmune disease or immunodeficiency/immunosuppression;
-
Thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy;
-
-Suffering from serious cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc;
-
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
-
Medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders;
-
Have received immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy);
-
Receipt of blood products ;
- Receipt of other investigational drugs in the past 30 days;
-
Receipt of attenuated live vaccines in the past 14 days;
-
Receipt of inactivated or subunit vaccines in the past 7 days;
-
Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
-
Axillary temperature >37.0°C;
-
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Vaccine-lot 1 Experimental vaccine 300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 1 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. Safety group in adults Experimental vaccine 24 adults will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine. Safety group in children Experimental vaccine 24 children will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine. Safety group in infants Experimental vaccine 24 infants will receive 4 doses of vaccine according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months to evaluate the safety of msIPV vaccine . Experimental Vaccine-lot 3 Experimental vaccine 300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 3 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. IPV control group IPV control vaccine 300 infants will receive 4 doses of IPV vaccine produced by Pasteur according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. Experimental Vaccine-lot 2 Experimental vaccine 300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 2 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. single-person sIPV control group single-person sIPV control vaccine 300 infants will receive 4 doses of single-dose sIPV vaccine produced by Pasteur according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months.
- Primary Outcome Measures
Name Time Method Safety index-incidence of adverse reactions Within 30 days after each dose Incidence of adverse reactions within 30 days after each dose
Immunogenicity index-Geometric mean titers (GMT) 30 days after primary immunization GMT 30 days after primary immunization in msIPV vaccination group
Immunogenicity index- seroconversion rate of neutralizing antibody 30 days after primary immunization Seroconversion rate of neutralizing antibody 30 days after primary immunization in combined experiment group and IPV control group
- Secondary Outcome Measures
Name Time Method Safety index-incidence of adverse reactions Within 7 days after each dose Incidence of adverse reactions within 7 days after each dose
Safety index-the incidence of adverse reactions During the period of safety monitoring Incidence of SAE during the period of safety monitoring
Immunogenicity index- Neutralizing antibody positive rate Before booster dose Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64 and GMT before booster dose
Immunogenicity index- Neutralizing antibody positive rate and GMI 30 days after primary immunization Neutralizing antibody positive rate and GMI and percentage of subjects with antibody ≥1:64 30 days after primary immunization
Immunogenicity index-Neutralizing antibody positive rate,GMT and GMI 30 days after booster dose Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64, GMT and GMI 30 days after booster dose
Trial Locations
- Locations (2)
Xiangfu District Center for Disease Prevention and Control
🇨🇳Kaifeng, Henan, China
Xiangcheng County Center for Disease Control and Prevention
🇨🇳Xuchang, Henan, China