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

NCT03822754 | Completed Phase 3

• 1 other identifier: PRO-sIPV-3001-1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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 '1+2' sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants

Conditions

Poliomyelitis

Keywords

Sabin strain; Inactivated poliovirus vaccine; poliomyelitis; safety; immunogenicity; infant; sequential schedule

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The incidences of solicited adverse events (AEs) within 7 or 14 days after each dose of each group.

  7 days or 14 days

• The incidence of unsolicited AE within 30 days after each dose of each group.

  30 days

• Incidence of serious adverse events (SAEs) during the period of safety monitoring.

  30 days.

• Type I,II and III neutralizing antibody positive rate of each group after primary immunization

  30 days

• Type I,II and III post-immune geometric mean titer (GMT) of each group after primary immunization.

  30 days

Study Arms (2)

Experimental Group

EXPERIMENTAL

sIPV-bOPV-bOPV vaccination schedule

Biological: sIPV-bOPV-bOPV vaccination schedule

Control Group

ACTIVE COMPARATOR

wIPV-bOPV-bOPV vaccination schedule

Biological: wIPV-bOPV-bOPV vaccination schedule

Interventions

sIPV-bOPV-bOPV vaccination schedule BIOLOGICAL

Single intramuscular injection of the experimental sIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Vaccine Technology Co., Ltd. The poliovirus (Live) vaccine type I \& type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.

Experimental Group

wIPV-bOPV-bOPV vaccination schedule BIOLOGICAL

Single intramuscular injection of the control wIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively.The control wild strain inactivated poliovirus vaccine (wIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I \& type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.

Control Group

Eligibility Criteria

• Age: 60 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Guanyun Center for Disease Control and Prevention

Lianyungang, Jiangsu, 222200, China

Location

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Yuemei Hu

  Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 30, 2019
• Study Start: June 6, 2018
• Primary Completion: September 26, 2018
• Study Completion: December 11, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

CN (1)