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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT05386810•Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

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

Age

0 - 49 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Healthy adults aged 18-49 days;
•Proven legal identification;
•The subject can understand and voluntarily sign the informed consent form.
•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.
•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

•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;
+45 more criteria

Locations (2)

Xiangfu District Center for Disease Prevention and Control

Kaifeng, Henan, China

Xiangcheng County Center for Disease Control and Prevention

Xuchang, Henan, China

Key Dates

Start Date

November 5, 2020

Primary Completion Date

October 8, 2022

Completion Date

July 20, 2023

Last Updated

April 15, 2024

Enrollment

1,572

ACTUAL participants

Conditions

Poliomyelitis

Interventions

Experimental vaccine

BIOLOGICAL

IPV control vaccine

BIOLOGICAL

single-person sIPV control vaccine

BIOLOGICAL

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RECRUITINGPHASE2/PHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

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Booster Dose of sIPV Co-administered With MMR and HepA-I.

Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants