Back to resultsA Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a "2+1"Sequential Schedule With bOPV in Infants
Primary Purpose
Poliomyelitis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
sIPV-sIPV-bOPV vaccination schedule
wIPV-wIPV-bOPV vaccination schedule
Sponsored by
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant, sequential schedule
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;
Sites / Locations
- Pizhou Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
sIPV-sIPV-bOPV vaccination schedule
wIPV-wIPV-bOPV vaccination schedule
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Incidence of serious adverse events (SAEs) during the period of safety monitoring.
SAEs during the period of safety monitoring will be collected.
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).
Type I,II and III post-immune geometric mean titer (GMT) of each group after primary immunization.
GMT of each group after primary immunization
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.
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.
Full Information
NCT ID
NCT03822767
First Posted
January 29, 2019
Last Updated
January 29, 2019
Sponsor
Sinovac Biotech Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03822767
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant, sequential schedule
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
sIPV-sIPV-bOPV vaccination schedule
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
wIPV-wIPV-bOPV vaccination schedule
Intervention Type
Biological
Intervention Name(s)
sIPV-sIPV-bOPV vaccination schedule
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
wIPV-wIPV-bOPV vaccination schedule
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
The incidences of solicited adverse events (AEs) within 7 or 14 days after each dose of each group.
Description
Solicited AEs occurred within 7 days (for sIPV) or 14 days (for bOPV) after each injection will be collected.
Time Frame
7 days or 14 days
Title
The incidence of unsolicited AE within 30 days after each dose of each group.
Description
Unsolicited AEs occurred within 30 days after each injection will be collected.
Time Frame
30 days
Title
Incidence of serious adverse events (SAEs) during the period of safety monitoring.
Description
SAEs during the period of safety monitoring will be collected.
Time Frame
30 days
Title
Type I,II and III neutralizing antibody positive rate of each group after primary immunization
Description
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).
Time Frame
30 days
Title
Type I,II and III post-immune geometric mean titer (GMT) of each group after primary immunization.
Description
GMT of each group after primary immunization
Time Frame
30 days
Title
Type I,II and III post-immune geometric mean fold increase (GMI) of each group after primary immunization.
Description
The GMI is the increase of post-immune GMT from pre-immune GMT.
Time Frame
30 days
Title
Type I,II and III percentage of subjects with post-immune antibody level ≥1:64 of each group after primary immunization.
Description
Subjects whose post-immune antibody level ≥ 1:64 will be collected.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuemei Hu
Organizational Affiliation
Jiangsu Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pizhou Center for Disease Control and Prevention
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221300
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a "2+1"Sequential Schedule With bOPV in Infants
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