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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

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Experimental vaccine
IPV control vaccine
single-person sIPV control vaccine
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

2 Months - 49 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiangfu District Center for Disease Prevention and Control
  • Xiangcheng County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Safety group in adults

Safety group in children

Safety group in infants

Experimental Vaccine-lot 1

Experimental Vaccine-lot 2

Experimental Vaccine-lot 3

IPV control group

single-person sIPV control group

Arm Description

24 adults will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine.

24 children will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV 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 .

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Safety index-incidence of adverse reactions
Incidence of adverse reactions within 30 days after each dose
Immunogenicity index-Geometric mean titers (GMT)
GMT 30 days after primary immunization in msIPV vaccination group
Immunogenicity index- seroconversion rate of neutralizing antibody
Seroconversion rate of neutralizing antibody 30 days after primary immunization in combined experiment group and IPV control group

Secondary Outcome Measures

Safety index-incidence of adverse reactions
Incidence of adverse reactions within 7 days after each dose
Safety index-the incidence of adverse reactions
Incidence of SAE during the period of safety monitoring
Immunogenicity index- Neutralizing antibody positive rate and GMI
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
Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64 and GMT before booster dose
Immunogenicity index-Neutralizing antibody positive rate,GMT and GMI
Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64, GMT and GMI 30 days after booster dose

Full Information

First Posted
May 18, 2022
Last Updated
September 21, 2023
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05386810
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
October 8, 2022 (Actual)
Study Completion Date
July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The clinical trial is divided into two stages: the first stage is an open design, and the second stage is a randomized ,blind control design
Allocation
Randomized
Enrollment
1572 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety group in adults
Arm Type
Experimental
Arm Description
24 adults will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine.
Arm Title
Safety group in children
Arm Type
Experimental
Arm Description
24 children will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine.
Arm Title
Safety group in infants
Arm Type
Experimental
Arm Description
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 .
Arm Title
Experimental Vaccine-lot 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental Vaccine-lot 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental Vaccine-lot 3
Arm Type
Experimental
Arm Description
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.
Arm Title
IPV control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
single-person sIPV control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Experimental vaccine
Other Intervention Name(s)
msIPV
Intervention Description
Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml)-investigational vaccine produced by Sinovac Biotech Co., Ltd. Inactivated Sabin poliovirus antigen (per 0.5ml): type 1 (15DU), type 2 (45DU), and type 3 (45DU)in 2.5 ml mixture of medium 199,glycine,formaldehyde,sodium chloride,potassium chloride,calcium chloride,magnesium sulfate,disodium phosphate,sodium dihydrogen phosphate,2 - phenoxyethanol for per injection.
Intervention Type
Biological
Intervention Name(s)
IPV control vaccine
Intervention Description
Inactivated Poliovirus Vaccine - control vaccine produced by Sanofi. Inactivated poliovirus antigens: Mahoney strain for type 1 (40DU), MEF-1 strain for type 2 (8DU), Saukett strains for type 3 (32DU) in 0.5 ml mixture of 2- phenoxyethanol,ethanol,formaldehyde,hanks199 medium (containing amino acids, mineral salts, vitamins, glucose, polysorbate 80 and water for injection),hydrochloric acid or sodium hydroxide (for pH value adjustment),trace amounts of antibiotics (neomycin, streptomycin and polymyxin B)for per injection.
Intervention Type
Biological
Intervention Name(s)
single-person sIPV control vaccine
Intervention Description
Sabin Inactivated Poliovirus Vaccine (Vero cell) (0.5ml) -control vaccine produced by Sinovac Biotech Co., Ltd. Inactivated Sabin poliovirus antigen: type 1 (15DU), type 2 (45DU), and type 3 (45DU)in 0.5 ml mixture of medium 199,glycine,formaldehyde,sodium chloride,potassium chloride,calcium chloride,magnesium sulfate,disodium phosphate,sodium dihydrogen phosphate for per injection.
Primary Outcome Measure Information:
Title
Safety index-incidence of adverse reactions
Description
Incidence of adverse reactions within 30 days after each dose
Time Frame
Within 30 days after each dose
Title
Immunogenicity index-Geometric mean titers (GMT)
Description
GMT 30 days after primary immunization in msIPV vaccination group
Time Frame
30 days after primary immunization
Title
Immunogenicity index- seroconversion rate of neutralizing antibody
Description
Seroconversion rate of neutralizing antibody 30 days after primary immunization in combined experiment group and IPV control group
Time Frame
30 days after primary immunization
Secondary Outcome Measure Information:
Title
Safety index-incidence of adverse reactions
Description
Incidence of adverse reactions within 7 days after each dose
Time Frame
Within 7 days after each dose
Title
Safety index-the incidence of adverse reactions
Description
Incidence of SAE during the period of safety monitoring
Time Frame
During the period of safety monitoring
Title
Immunogenicity index- Neutralizing antibody positive rate and GMI
Description
Neutralizing antibody positive rate and GMI and percentage of subjects with antibody ≥1:64 30 days after primary immunization
Time Frame
30 days after primary immunization
Title
Immunogenicity index- Neutralizing antibody positive rate
Description
Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64 and GMT before booster dose
Time Frame
Before booster dose
Title
Immunogenicity index-Neutralizing antibody positive rate,GMT and GMI
Description
Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64, GMT and GMI 30 days after booster dose
Time Frame
30 days after booster dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanxia Wang, Master
Organizational Affiliation
Henan Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangfu District Center for Disease Prevention and Control
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
475100
Country
China
Facility Name
Xiangcheng County Center for Disease Control and Prevention
City
Xuchang
State/Province
Henan
ZIP/Postal Code
461700
Country
China

12. IPD Sharing Statement

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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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