Clinical trial NCT05386810: 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
Official title: A Clinical Trial With an Open-label Phase to Evaluate the Safety of Five-dose Sabin Inactivated Poliovirus Vaccine (Vero Cell)（ msIPV） in Adults, Children and Infants, and a Blinded,Randomized and Controlled Phase to Evaluate the Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poliomyelitis
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-23
Enrollment: 1572
Sex: ALL
Minimum age (years): 2
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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:

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.

Primary outcomes:
measure: Safety index-incidence of adverse reactions
timeFrame: Within 30 days after each dose
measure: Immunogenicity index-Geometric mean titers (GMT)
timeFrame: 30 days after primary immunization
measure: Immunogenicity index- seroconversion rate of neutralizing antibody
timeFrame: 30 days after primary immunization
Secondary outcomes:
measure: Safety index-incidence of adverse reactions
timeFrame: Within 7 days after each dose
measure: Safety index-the incidence of adverse reactions
timeFrame: During the period of safety monitoring
measure: Immunogenicity index- Neutralizing antibody positive rate and GMI
timeFrame: 30 days after primary immunization
measure: Immunogenicity index- Neutralizing antibody positive rate
timeFrame: Before booster dose
measure: Immunogenicity index-Neutralizing antibody positive rate,GMT and GMI
timeFrame: 30 days after booster dose
Other outcomes:
Locations:
city: Kaifeng
country: China
facility: Xiangfu District Center for Disease Prevention and Control
state: Henan
city: Xuchang
country: China
facility: Xiangcheng County Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Provincial Center for Disease Prevention and Control
name: Yanxia Wang, Master
role: PRINCIPAL_INVESTIGATOR
References: