Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine

Sinovac

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis

Treatments: Biological: Three doses control wIPV at the schedule of 2,3,4 months of age; Biological: Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age; Biological: Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age; Biological: Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age

Study type: Interventional

Funder types: Industry

Identifiers

NCT04386707

PRO-sIPV-3002

Details and patient eligibility

About

The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and evaluate the non-inferiority of investigational vaccine against a post-market inactivated polio vaccine.

Full description

This study is a randomized, double-blinded, and positive-controlled clinical trial. A total of 1300 infants aged 2 months will be enrolled and assigned to 4 groups in a ratio of 1:1:1:1 to receive vaccination of 3 lots of investigational sIPV and control IPV manufactured by Sanofi Pasteur S.A respectively. Each subjects should finish the three-doses primary vaccination at the schedule of 2,3,4 months of age. Thirty-days safety observation after each dose of vaccination will be carried out. Venous blood should be collected from all the subjects before and 30 days after the three-doses primary vaccination, for the neutralizing antibody assay, and further to evaluate the immunogenicity.

Enrollment: 1,300 patients

Sex: All

Ages: 60 to 89 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infants aged 60-89 days;
• legal identity;
• Informed consent form has been signed by guardians.

Exclusion criteria

• Vaccination history of polio 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;
• Serious nervous system disorders (epilepsy, convulsion or tic) or mental disorders;
• Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors;
• Receipt of immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis);
• Receipt of blood products prior to this study;
• Receipt of other study drugs within 30 days prior to this study;
• Receipt of live attenuated vaccines within 14 days prior to this study;
• Receipt of subunit or inactivated vaccines within 7 days prior to this study;
• Acute diseases or acute exacerbation of chronic diseases within recent 7 days;
• Axillary temperature >37.0℃;
• Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,300 participants in 4 patient groups

Experimental Vaccine-lot 1

Experimental group

Description:

sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.

Treatment:

Biological: Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age

Experimental Vaccine-lot 2

Experimental group

Description:

sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.

Treatment:

Biological: Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age

Experimental Vaccine-lot 3

Experimental group

Description:

sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.

Treatment:

Biological: Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age

Control Vaccine

Active Comparator group

Description:

Wild strain IPV (wIPV）manufactured by Sanofi Pasteur S.A.

Treatment:

Biological: Three doses control wIPV at the schedule of 2,3,4 months of age