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Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.

Primary Purpose

Polio and Post-Polio Syndrome

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Three-dose regimen of high dosage investigational sIPV
Three-dose regimen of medium dosage investigational sIPV
Three-dose regimen of low dosage investigational sIPV
Three-dose regimen of commercialized sIPV
Three-dose regimen of commercialized IPV
Sponsored by
Jiangsu Province Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polio and Post-Polio Syndrome

Eligibility Criteria

60 Days - 90 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteer aged 2 months (60~90 days) old without prior vaccination of poliovirus and any contraindication for vaccination;
  • 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;
  • Axillary temperature ≤ 37.0 °C;

Exclusion Criteria:

  • Preterm or low birth weight infants;
  • Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
  • History of polio;
  • Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
  • 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;
  • Autoimmune disease or immunodeficiency/immunosuppressive;
  • Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
  • Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases;
  • Mother of the participant has HIV infection;
  • Acute illness or acute exacerbation of chronic disease within the past 7 days;
  • Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C);
  • Receipt of any subunit or inactivated vaccine within the past 7 day;
  • Receipt of any live attenuated vaccine within the past 14 days;
  • Receipt of any blood product within the past 3 months;
  • Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;

Sites / Locations

  • Jiangsu Provincial Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Experimental Group - High dosage

Experimental Group - Medium dosage

Experimental Group - Low dosage

Control Group -commercialized sIPV

Control Group -commercialized IPV

Arm Description

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized sIPV

Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV

Outcomes

Primary Outcome Measures

The seroconversion rates (SCRs) of each group after three-dose regimen
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.
The post-immune geometric mean titer (GMT) of each group after three-dose regimen
GMT of each group 28~42 days after three-dose regimen.
The geometric mean fold increase (GMI) of each group after three-dose regimen
The GMI is the increase of post-immune GMT from pre-immune GMT.

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 incidences of serious adverse events (SAEs) of each group
SAEs occurred within 30 days after each injection will be collected.

Full Information

First Posted
April 2, 2019
Last Updated
April 2, 2019
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Beijing Minhai Biotechnology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03902054
Brief Title
Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.
Official Title
A Randomized, Blinded and Controlled Phase II Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Infants.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 28, 2017 (Actual)
Primary Completion Date
May 26, 2018 (Actual)
Study Completion Date
December 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Beijing Minhai Biotechnology 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
This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polio and Post-Polio Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group - High dosage
Arm Type
Experimental
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV
Arm Title
Experimental Group - Medium dosage
Arm Type
Experimental
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV
Arm Title
Experimental Group - Low dosage
Arm Type
Experimental
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV
Arm Title
Control Group -commercialized sIPV
Arm Type
Active Comparator
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized sIPV
Arm Title
Control Group -commercialized IPV
Arm Type
Active Comparator
Arm Description
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV
Intervention Type
Biological
Intervention Name(s)
Three-dose regimen of high dosage investigational sIPV
Intervention Description
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
Intervention Type
Biological
Intervention Name(s)
Three-dose regimen of medium dosage investigational sIPV
Intervention Description
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
Intervention Type
Biological
Intervention Name(s)
Three-dose regimen of low dosage investigational sIPV
Intervention Description
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
Intervention Type
Biological
Intervention Name(s)
Three-dose regimen of commercialized sIPV
Intervention Description
The control vaccine was manufactured by Chinese Academy of Medical Sciences.
Intervention Type
Biological
Intervention Name(s)
Three-dose regimen of commercialized IPV
Intervention Description
The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
Primary Outcome Measure Information:
Title
The seroconversion rates (SCRs) of each group after three-dose regimen
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.
Time Frame
28~42 days
Title
The post-immune geometric mean titer (GMT) of each group after three-dose regimen
Description
GMT of each group 28~42 days after three-dose regimen.
Time Frame
28~42 days
Title
The geometric mean fold increase (GMI) of each group after three-dose regimen
Description
The GMI is the increase of post-immune GMT from pre-immune GMT.
Time Frame
28~42 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 incidences of serious adverse events (SAEs) of each group
Description
SAEs occurred within 30 days after each injection 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 aged 2 months (60~90 days) old without prior vaccination of poliovirus and any contraindication for vaccination; 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; Axillary temperature ≤ 37.0 °C; Exclusion Criteria: Preterm or low birth weight infants; Congenital malformation, developmental disorders, genetic defects, or severe malnutrition; History of polio; Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness; 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; Autoimmune disease or immunodeficiency/immunosuppressive; Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy; Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases; Mother of the participant has HIV infection; Acute illness or acute exacerbation of chronic disease within the past 7 days; Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C); Receipt of any subunit or inactivated vaccine within the past 7 day; Receipt of any live attenuated vaccine within the past 14 days; Receipt of any blood product within the past 3 months; Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Facility Information:
Facility Name
Jiangsu Provincial Center for Diseases Control and Prevention
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32867698
Citation
Jia S, Tang R, Li G, Hu Y, Liang Q. The effect of maternal poliovirus antibodies on the immune responses of infants to poliovirus vaccines. BMC Infect Dis. 2020 Aug 31;20(1):641. doi: 10.1186/s12879-020-05348-1.
Results Reference
derived

Learn more about this trial

Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.

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