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

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Brief Title

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 a Open-label Phase to Evaluate the Safety of 5-person 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

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/dose)(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 a open-label to evaluate the safety of
      Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml/dose)(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 stageⅡ. 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-person sIPV control group) according to the ratio of 1:1:1:1:1. Subjects in 3
      experimental groups will receive 5-person sIPV produced by Sinovac for three lots,subjects in
      IPV control group will receive IPV produced by Pasteur, and subjects in single-person sIPV
      control group will receive single-person sIPV produced by Sinovac.All subjects will received
      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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Safety index-incidence of adverse reactions

Secondary Outcome

 Safety index-incidence of adverse reactions

Condition

Poliomyelitis

Intervention

Experimental vaccine

Study Arms / Comparison Groups

 Safety group in adults
Description:  24 adults will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

1572

Start Date

November 5, 2020

Completion Date

December 5, 2022

Primary Completion Date

October 5, 2022

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.
      

Gender

All

Ages

2 Months - 49 Years

Accepts Healthy Volunteers

No

Contacts

Yanxia Wang, Master, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05386810

Organization ID

PRO-msIPV-3001


Responsible Party

Sponsor

Study Sponsor

Sinovac Biotech Co., Ltd


Study Sponsor

Yanxia Wang, Master, Principal Investigator, Henan Provincial Center for Disease Prevention and Control


Verification Date

May 2022