Clinical trial NCT03526978: An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
Official title: A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Sabin Inactivated Poliovirus Vaccine (Vero Cell) 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
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-05-16
Enrollment: 1200
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 phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.

Detailed description: The study is a randomized, double-blind, controlled randomized, double-blind, controlled clinical trial clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) manufactured by Sinovac Vaccine Technology Co., Ltd in 2-month-old infants. The control vaccine is a commercialized Inactivated Poliovirus Vaccine manufactured by Sanofi Pasteur company. 1200 healthy infants between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1.

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 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 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 seroconversion rates (SCRs) of each group after primary immunization.
timeFrame: 90 days
Secondary outcomes:
measure: The incidences of solicited adverse events (AEs) of each group.
timeFrame: 7 days
measure: The incidences of unsolicited adverse events (AEs) of each group.
timeFrame: 30 days
measure: The incidence of serious adverse events (SAEs) during the period of safety monitoring of each group.
timeFrame: 90-420 days.
measure: The post-immune antibody positive rate of each group after primary immunization.
timeFrame: 90 days
measure: The post-immune geometric mean titer (GMT) of each group after primary immunization.
timeFrame: 90 days.
measure: The geometric mean fold increase (GMI) of each group after primary immunization.
timeFrame: 90 days
measure: The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization.
timeFrame: 90 days
measure: The antibody positive rate of each group before booster dose.
timeFrame: 420 days
measure: The geometric mean titer (GMT) of each group before booster dose.
timeFrame: 420 days.
measure: The geometric mean fold increase (GMI) of each group before booster dose.
timeFrame: 420 days
measure: The percentage of subjects with antibody ≥ 1:64 of each group before booster dose.
timeFrame: 420 days
measure: The post-immune antibody positive rate of each group after booster dose.
timeFrame: 570 days
measure: The post-immune geometric mean titer (GMT) of each group after booster dose.
timeFrame: 570 days
measure: The geometric mean fold increase (GMI) of each group after booster dose.
timeFrame: 570 days
measure: The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose.
timeFrame: 570 days
Other outcomes:
Locations:
city: Pizhou
country: China
facility: Pizhou County 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:
citation: Hu Y, Wang J, Zeng G, Chu K, Jiang D, Zhu F, Ying Z, Chen L, Li C, Zhu F, Yin W. Immunogenicity and Safety of a Sabin Strain-Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial. J Infect Dis. 2019 Oct 8;220(10):1551-1557. doi: 10.1093/infdis/jiy736.