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

NCT05386810 | Completed Phase 3

• 1 other identifier: PRO-msIPV-3001
• Study Type: interventional
• Target: 1,572
• Locations: 1 country
• Sites: 2

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.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (3)

• Safety index-incidence of adverse reactions

  Incidence of adverse reactions within 30 days after each dose

  Within 30 days after each dose

• Immunogenicity index-Geometric mean titers (GMT)

  GMT 30 days after primary immunization in msIPV vaccination group

  30 days after primary immunization

• 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

  30 days after primary immunization

Secondary Outcomes (5)

• Safety index-incidence of adverse reactions

  Within 7 days after each dose

• Safety index-the incidence of adverse reactions

  During the period of safety monitoring

• Immunogenicity index- Neutralizing antibody positive rate and GMI

  30 days after primary immunization

• Immunogenicity index- Neutralizing antibody positive rate

  Before booster dose

• Immunogenicity index-Neutralizing antibody positive rate,GMT and GMI

  30 days after booster dose

Study Arms (8)

Safety group in adults

EXPERIMENTAL

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

Biological: Experimental vaccine

Safety group in children

EXPERIMENTAL

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

Biological: Experimental vaccine

Safety group in infants

EXPERIMENTAL

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 .

Biological: Experimental vaccine

Experimental Vaccine-lot 1

EXPERIMENTAL

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.

Biological: Experimental vaccine

Experimental Vaccine-lot 2

EXPERIMENTAL

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.

Biological: Experimental vaccine

Experimental Vaccine-lot 3

EXPERIMENTAL

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.

Biological: Experimental vaccine

IPV control group

ACTIVE COMPARATOR

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.

Biological: IPV control vaccine

single-person sIPV control group

ACTIVE COMPARATOR

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.

Biological: single-person sIPV control vaccine

Interventions

Experimental vaccine BIOLOGICAL

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.

Also known as: msIPV

Experimental Vaccine-lot 1; Experimental Vaccine-lot 2; Experimental Vaccine-lot 3; Safety group in adults; Safety group in children; Safety group in infants

IPV control vaccine BIOLOGICAL

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.

IPV control group

single-person sIPV control vaccine BIOLOGICAL

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.

single-person sIPV control group

Eligibility Criteria

• Age: 2 Months - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (2)

Xiangfu District Center for Disease Prevention and Control

Kaifeng, Henan, 475100, China

Location

Xiangcheng County Center for Disease Control and Prevention

Xuchang, Henan, 461700, China

Location

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Yanxia Wang, Master

  Henan Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: November 5, 2020
• Primary Completion: October 8, 2022
• Study Completion: July 20, 2023
• Last Updated: April 15, 2024

Record last verified: 2022-05

Locations

CN (2)