Clinical trial NCT04386707: Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poliomyelitis
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-05-13
Enrollment: 1300
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Immunogenicity index-Geometric mean titer of neutralizing antibody
timeFrame: The 30th day after the third dose vaccination
measure: Immunogenicity index-Seroconversion rates of neutralizing antibody
timeFrame: The 30th day after the third dose vaccination
Secondary outcomes:
measure: Immunogenicity index-Seropositive rate of neutralizing antibody
timeFrame: The 30th day after the third dose vaccination
measure: Immunogenicity index-Geometric mean ratio of neutralizing antibody
timeFrame: The 30th day after the third dose vaccination
measure: Safety index-Incidence of solicited adverse events
timeFrame: Day 0-7 after each dose vaccination, day 0 refers to the day of vaccination
measure: Safety index-Incidence of unsolicited adverse events
timeFrame: Day 0-30 after each dose vaccination, day 0 refers to the day of vaccination
measure: Safety index-Incidence of serious adverse events (SAEs)
timeFrame: From the beginning of vaccination to 30 days after the third dose vaccination
Other outcomes:
Locations:
city: Honghe
country: China
facility: Mile City Center for Disease Control and Prevention
state: Yunnan
city: Honghe
country: China
facility: Gejiu County Center for Disease Control and Prevention
state: Yunnan
city: Wenshan
country: China
facility: Yanshan County Center for Disease Control and Prevention
state: Yunnan
city: Wenshan
country: China
facility: Qiubei County Center for Disease Control and Prevention
state: Yunnan
Study officials:
affiliation: Yunnan Provincial Center for Disease Control and Prevention
name: Yan Zheng, Master
role: PRINCIPAL_INVESTIGATOR
References: