Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine

Poliomyelitis Clinical Trial

Official title:

A Randomized, Double-blinded, Controlled Clinical Trial to Evaluate Lot Consistency, Immunogenicity and Safety of Sabin Inactivated Polio Vaccine (Vero Cell) in 2-month-old Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386707
• Other study ID #: PRO-sIPV-3002
• Status: Completed
• Phase: Phase 3
• Start date: May 11, 2020
• Est. completion date: October 20, 2020

Study information

• Verified date: August 2021
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: October 20, 2020
• Est. primary completion date: May 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Days to 89 Days

Eligibility

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.

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

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

Locations

Country	Name	City	State
China	Gejiu County Center for Disease Control and Prevention	Honghe	Yunnan
China	Mile City Center for Disease Control and Prevention	Honghe	Yunnan
China	Qiubei County Center for Disease Control and Prevention	Wenshan	Yunnan
China	Yanshan County Center for Disease Control and Prevention	Wenshan	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Immunogenicity index-Seropositive rate 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.	The 30th day after the third dose vaccination
Secondary	Immunogenicity index-Geometric mean ratio of neutralizing antibody	Micro-neutralization method will be used in the neutralizing antibody assay; Geometric mean ratio of neutralizing antibody titer after vaccination divided by that before vaccination	The 30th day after the third dose vaccination
Secondary	Safety index-Incidence of solicited adverse events	Solicited adverse events refer to the adverse events occur within day 0-7 after each dose vaccination with the solicited symptoms including injection-site induration, redness, swelling, rashes, or pruritus, and fever, allergic reactions, abnormal activity level, loss of appetite, nausea, vomiting and diarrhea.	Day 0-7 after each dose vaccination, day 0 refers to the day of vaccination
Secondary	Safety index-Incidence of unsolicited adverse events	Unsolicited adverse events refer to the unsolicited symptoms occur within day 0-7, and any symptoms occur out of that period	Day 0-30 after each dose vaccination, day 0 refers to the day of vaccination
Secondary	Safety index-Incidence of serious adverse events (SAEs)	SAEs refers to the events occur in the process of clinical trial which may need hospitalization, prolongation of hospitalization time, disability, dysfunction, be life-threatening or death or lead to congenital malformation.	From the beginning of vaccination to 30 days after the third dose vaccination