Clinical trial NCT03822767: A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a "2+1"Sequential Schedule With bOPV in Infants
Official title: A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in a '2+1'Sequential Schedule With Bivalent Oral Poliovirus Vaccine in 2-month-old Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poliomyelitis
Keywords: Sabin strain
Inactivated poliovirus vaccine
poliomyelitis
safety
immunogenicity
infant
sequential schedule
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 240
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '2+1'sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants

Detailed description: his study is a randomized, double-blind, active-controlled phrase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of sIPV manufactured by Sinovac Biotech Co., Ltd in a '2+1' sequential schedule with bOPV in 2-month-old infants. 240 infants aged between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1. The experimental group received sIPV-sIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group received wIPV-wIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2). The control wIPV was manufactured by SANOFI PASTEUR S.A.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer between 60-90 days old;
* Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
* Proven legal identity;
* Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
* Complying with the requirement of the study protocol;

Exclusion Criteria:

* Prior vaccination with Poliovirus Vaccine;
* History of allergy to any vaccine, or any ingredient, excipients and Gentamycin Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
* Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
* Autoimmune disease or immunodeficiency/immunosuppressive;
* Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
* Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
* Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry;
* Blood product prior to study entry;
* Any other investigational medicine(s) within 30 days prior to study entry;
* Any live attenuated vaccine within 14 days prior to study entry;
* Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Axillary temperature \> 37.0 °C;
* Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

Primary outcomes:
measure: The difference between experimental group and control group of type I,III neutralizing antibody seroconversion rate after primary immunization. And the lower limit of 95% confidence intervals of the difference value.
timeFrame: 30 days
Secondary outcomes:
measure: The incidences of solicited adverse events (AEs) within 7 or 14 days after each dose of each group.
timeFrame: 7 days or 14 days
measure: The incidence of unsolicited AE within 30 days after each dose of each group.
timeFrame: 30 days
measure: Incidence of serious adverse events (SAEs) during the period of safety monitoring.
timeFrame: 30 days
measure: Type I,II and III neutralizing antibody positive rate of each group after primary immunization
timeFrame: 30 days
measure: Type I,II and III post-immune geometric mean titer (GMT) of each group after primary immunization.
timeFrame: 30 days
measure: Type I,II and III post-immune geometric mean fold increase (GMI) of each group after primary immunization.
timeFrame: 30 days
measure: Type I,II and III percentage of subjects with post-immune antibody level ≥1:64 of each group after primary immunization.
timeFrame: 30 days
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Pizhou Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial Center for Disease Control and Prevention
name: Yuemei Hu
role: PRINCIPAL_INVESTIGATOR
References: