A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a "2+1"Sequential Schedule With bOPV in Infants

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

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

Study Overview

• Status: Completed
• Conditions: Poliomyelitis
• Intervention / Treatment: Biological: sIPV-sIPV-bOPV vaccination schedule; Biological: wIPV-wIPV-bOPV vaccination schedule

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221300
      • Pizhou Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group; sIPV-sIPV-bOPV vaccination schedule	Biological: sIPV-sIPV-bOPV vaccination schedule; Two intramuscular injections of the investigational vaccine (0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Biotech Co., Ltd . The poliovirus (Live) vaccine type I & type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
ACTIVE_COMPARATOR: Control Group; wIPV-wIPV-bOPV vaccination schedule	Biological: wIPV-wIPV-bOPV vaccination schedule; Two intramuscular injections of the control vaccine(0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I & type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidences of solicited adverse events (AEs) within 7 or 14 days after each dose of each group.	Solicited AEs occurred within 7 days (for sIPV) or 14 days (for bOPV) after each injection will be collected.	7 days or 14 days
The incidence of unsolicited AE within 30 days after each dose of each group.	Unsolicited AEs occurred within 30 days after each injection will be collected.	30 days
Incidence of serious adverse events (SAEs) during the period of safety monitoring.	SAEs during the period of safety monitoring will be collected.	30 days
Type I,II and III neutralizing antibody positive rate of each group after primary immunization	Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).	30 days
Type I,II and III post-immune geometric mean titer (GMT) of each group after primary immunization.	GMT of each group after primary immunization	30 days
Type I,II and III post-immune geometric mean fold increase (GMI) of each group after primary immunization.	The GMI is the increase of post-immune GMT from pre-immune GMT.	30 days
Type I,II and III percentage of subjects with post-immune antibody level ≥1:64 of each group after primary immunization.	Subjects whose post-immune antibody level ≥ 1:64 will be collected.	30 days

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2018
• Primary Completion (ACTUAL): September 20, 2018
• Study Completion (ACTUAL): December 11, 2018

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (ACTUAL): January 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: safety; immunogenicity; poliomyelitis; infant; Sabin strain; Inactivated poliovirus vaccine; sequential schedule
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis
• Other Study ID Numbers: PRO-sIPV-3001-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No