Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine
- Conditions
- Poliomyelitis
- Interventions
- Biological: Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of ageBiological: Three doses control wIPV at the schedule of 2,3,4 months of ageBiological: Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of ageBiological: Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
- Registration Number
- NCT04386707
- Lead Sponsor
- Sinovac Biotech Co., Ltd
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1300
- Healthy infants aged 60-89 days;
- legal identity;
- Informed consent form has been signed by guardians.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Vaccine-lot 2 Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. Control Vaccine Three doses control wIPV at the schedule of 2,3,4 months of age Wild strain IPV (wIPV）manufactured by Sanofi Pasteur S.A. Experimental Vaccine-lot 3 Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. Experimental Vaccine-lot 1 Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale.
- Primary Outcome Measures
Name Time Method Immunogenicity index-Seroconversion rates of neutralizing antibody The 30th day after the third dose vaccination 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.
Immunogenicity index-Geometric mean titer of neutralizing antibody The 30th day after the third dose vaccination Micro-neutralization method will be used in the neutralizing antibody assay
- Secondary Outcome Measures
Name Time Method Immunogenicity index-Geometric mean ratio of neutralizing antibody The 30th day after the third dose vaccination 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
Safety index-Incidence of serious adverse events (SAEs) From the beginning of vaccination to 30 days after the third dose vaccination 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.
Safety index-Incidence of solicited adverse events Day 0-7 after each dose vaccination, day 0 refers to the day of vaccination 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.
Safety index-Incidence of unsolicited adverse events Day 0-30 after each dose vaccination, day 0 refers to the day of vaccination Unsolicited adverse events refer to the unsolicited symptoms occur within day 0-7, and any symptoms occur out of that period
Immunogenicity index-Seropositive rate of neutralizing antibody The 30th day after the third dose vaccination 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.
Trial Locations
- Locations (4)
Yanshan County Center for Disease Control and Prevention
🇨🇳Wenshan, Yunnan, China
Mile City Center for Disease Control and Prevention
🇨🇳Honghe, Yunnan, China
Gejiu County Center for Disease Control and Prevention
🇨🇳Honghe, Yunnan, China
Qiubei County Center for Disease Control and Prevention
🇨🇳Wenshan, Yunnan, China