Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine

NCT04386707 | Completed Phase 3

• 1 other identifier: PRO-sIPV-3002
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (2)

• Immunogenicity index-Geometric mean titer of neutralizing antibody

  Micro-neutralization method will be used in the neutralizing antibody assay

  The 30th day after the third dose vaccination

• Immunogenicity index-Seroconversion rates of neutralizing antibody

  Micro-neutralization method will be used in the neutralizing antibody assay; Seropositive rates will be calculated based on the internationally accepted threshold value of ≥1:8. Seroconversion (1:8) is defined as a change from seronegative (\<1:8) to seropositive (≥1:8) or a 4-fold increase from baseline titers if seropositive.

  The 30th day after the third dose vaccination

Secondary Outcomes (5)

• Immunogenicity index-Seropositive rate of neutralizing antibody

  The 30th day after the third dose vaccination

• Immunogenicity index-Geometric mean ratio of neutralizing antibody

  The 30th day after the third dose vaccination

• Safety index-Incidence of solicited adverse events

  Day 0-7 after each dose vaccination, day 0 refers to the day of vaccination

• Safety index-Incidence of unsolicited adverse events

  Day 0-30 after each dose vaccination, day 0 refers to the day of vaccination

• Safety index-Incidence of serious adverse events (SAEs)

  From the beginning of vaccination to 30 days after the third dose vaccination

Study Arms (4)

Experimental Vaccine-lot 1

EXPERIMENTAL

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

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

Experimental Vaccine-lot 2

EXPERIMENTAL

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

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

Experimental Vaccine-lot 3

EXPERIMENTAL

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

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

Control Vaccine

ACTIVE COMPARATOR

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

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

Interventions

Three doses of experimental sIPV of lot 1 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

Experimental Vaccine-lot 1

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 2 at the schedule of 2,3,4 months of age

Experimental Vaccine-lot 2

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 3 at the schedule of 2,3,4 months of age

Experimental Vaccine-lot 3

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

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

Control Vaccine

Eligibility Criteria

• Age: 60 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (4)

Yanshan County Center for Disease Control and Prevention

Wenshan, Yunnan, 663100, China

Location

Qiubei County Center for Disease Control and Prevention

Wenshan, Yunnan, 663200, China

Location

Mile City Center for Disease Control and Prevention

Yisa, Yunnan, 652399, China

Location

Gejiu County Center for Disease Control and Prevention

Yisa, Yunnan, 661000, 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

• Yan Zheng, Master

  Yunnan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: May 11, 2020
• Primary Completion: May 11, 2020
• Study Completion: October 20, 2020
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)