Back to resultsAn Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
Primary Purpose
Poliomyelitis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Investigational sIPV
Control IPV
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
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;
Sites / Locations
- Pizhou County 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
The investigational vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd. Intervention: investigational sIPV
The control vaccine was manufactured by Sanofi Pasteur Company. Intervention: control IPV
Outcomes
Primary Outcome Measures
The seroconversion rates (SCRs) of each group after primary immunization.
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) of each group.
Solicited AEs occurred within 7 days after each injection will be collected.
The incidences of unsolicited adverse events (AEs) of each group.
Unsolicited AEs occurred within 30 days after each injection will be collected.
The incidence of serious adverse events (SAEs) during the period of safety monitoring of each group.
SAEs during the period of safety monitoring will be collected.
The post-immune 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).
The post-immune geometric mean titer (GMT) of each group after primary immunization.
GMT of each group after primary immunization which lasts 60 days.
The geometric mean fold increase (GMI) of each group after primary immunization.
The GMI is the increase of post-immune GMT from pre-immune GMT.
The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization.
Percentage of subjects with antibody ≥ 1:64 of each group after three-dose
The antibody positive rate of each group before booster dose.
Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. A booster dose at the age of 18months.
The geometric mean titer (GMT) of each group before booster dose.
GMT of each group before booster dose which occurred at the age of 18months.
The geometric mean fold increase (GMI) of each group before booster dose.
The GMI is the increase of post-immune GMT from pre-i mmune GMT.
The percentage of subjects with antibody ≥ 1:64 of each group before booster dose.
Percentage of subjects with antibody ≥ 1:64 of each group before booster dose which occurred at the age of 18months.
The post-immune antibody positive rate of each group after booster dose.
Subjects whose post-immune antibody level ≥ 1:8 are co
nsidered antibody positive
The post-immune geometric mean titer (GMT) of each group after booster dose.
GMT of each group after booster dose. The booster dose at the age of 18months
The geometric mean fold increase (GMI) of each group after booster dose.
The GMI is the increase of post-immune GMT from pre-immune GMT.
The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose.
Percentage of subjecs with antibody ≥ 1:64 of each group after booster dose which occurred at the age of 18months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03526978
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
October 18, 2017 (Actual)
Study Completion Date
April 18, 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
5. Study Description
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.
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The investigational vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd.
Intervention: investigational sIPV
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control vaccine was manufactured by Sanofi Pasteur Company. Intervention: control IPV
Intervention Type
Biological
Intervention Name(s)
Investigational sIPV
Intervention Description
Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months; Intervention: investigational sIPV
Intervention Type
Biological
Intervention Name(s)
Control IPV
Intervention Description
Three intramuscular injections of the control vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the control vaccine (0.5 ml) at 18 months; Intervention:control IPV
Primary Outcome Measure Information:
Title
The seroconversion rates (SCRs) of each group after primary immunization.
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
90 days
Secondary Outcome Measure Information:
Title
The incidences of solicited adverse events (AEs) of each group.
Description
Solicited AEs occurred within 7 days after each injection will be collected.
Time Frame
7 days
Title
The incidences of unsolicited adverse events (AEs) of each group.
Description
Unsolicited AEs occurred within 30 days after each injection will be collected.
Time Frame
30 days
Title
The incidence of serious adverse events (SAEs) during the period of safety monitoring of each group.
Description
SAEs during the period of safety monitoring will be collected.
Time Frame
90-420 days.
Title
The post-immune 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
90 days
Title
The post-immune geometric mean titer (GMT) of each group after primary immunization.
Description
GMT of each group after primary immunization which lasts 60 days.
Time Frame
90 days.
Title
The 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
90 days
Title
The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization.
Description
Percentage of subjects with antibody ≥ 1:64 of each group after three-dose
Time Frame
90 days
Title
The antibody positive rate of each group before booster dose.
Description
Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. A booster dose at the age of 18months.
Time Frame
420 days
Title
The geometric mean titer (GMT) of each group before booster dose.
Description
GMT of each group before booster dose which occurred at the age of 18months.
Time Frame
420 days.
Title
The geometric mean fold increase (GMI) of each group before booster dose.
Description
The GMI is the increase of post-immune GMT from pre-i mmune GMT.
Time Frame
420 days
Title
The percentage of subjects with antibody ≥ 1:64 of each group before booster dose.
Description
Percentage of subjects with antibody ≥ 1:64 of each group before booster dose which occurred at the age of 18months.
Time Frame
420 days
Title
The post-immune antibody positive rate of each group after booster dose.
Description
Subjects whose post-immune antibody level ≥ 1:8 are co
nsidered antibody positive
Time Frame
570 days
Title
The post-immune geometric mean titer (GMT) of each group after booster dose.
Description
GMT of each group after booster dose. The booster dose at the age of 18months
Time Frame
570 days
Title
The geometric mean fold increase (GMI) of each group after booster dose.
Description
The GMI is the increase of post-immune GMT from pre-immune GMT.
Time Frame
570 days
Title
The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose.
Description
Percentage of subjecs with antibody ≥ 1:64 of each group after booster dose which occurred at the age of 18months.
Time Frame
570 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 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;
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 County Center for Disease Control and Prevention
City
Pizhou
State/Province
Jiangsu
ZIP/Postal Code
221300
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
30958543
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.
Results Reference
derived
Learn more about this trial
An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
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