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Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
sIPV batch 1
sIPV batch 2
sIPV batch 3
Sponsored by
Institute of Medical Biology, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

2 Months - 3 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy infants of 2 months of age
  • The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card).
  • Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation.
  • Guardians are capable of using thermometer, graduated scale, filling diary card and contact card.
  • Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment.
  • Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample.
  • Axillary temperature ≤37℃

Exclusion Criteria:

  • Allergic to any active substance, inactive substance or materials used during production such as kanamycin.
  • Patients with fever or acute disease.
  • Have thrombocytopenia or hemorrhagic diseases
  • Patients undergoing immunosuppressive therapy or immunodeficiency
  • Have uncontrolled epilepsy or other progressive neurological disorders
  • Other situations that the investigator consider as non-eligible

Sites / Locations

  • Disease prevention and control center of Yunnan province

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Batch 1 of sIPV

Batch 2 of sIPV

Batch 3 of sIPV

Arm Description

The first commercial batch of sIPV

The second commercial batch of sIPV

The third commercial batch of sIPV

Outcomes

Primary Outcome Measures

Seroconversion rate of neutralizing antibody
Blood samples were collected before and after immunization. Seroconversion rate of serum neutralizing antibody was determined. Intergroup differences analysis of the post-immunization positive conversion and ≥4-fold increase rate of antibody was performed.
Local and systemic adverse reactions
Safety monitoring for local and systemic adverse reaction within 30 days after 3-dose primary immunization via close monitoring or diary card.

Secondary Outcome Measures

GMT of neutralizing antibody
Blood samples were taken before and after immunization for the determination of antibody level of serum neutralizing antibody. Intergroup differences analysis of antibody level was conducted.

Full Information

First Posted
January 6, 2020
Last Updated
October 7, 2023
Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Yunnan Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04224519
Brief Title
Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Official Title
Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
February 25, 2019 (Actual)
Study Completion Date
October 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Yunnan Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.
Detailed Description
This randomized and blind clinical study includes three test groups with 400 infants for each group. Sample estimation for this study has been conducted using statistical methods. A total of 1,200 2-month old healthy subjects were enrolled for inoculation of vaccine from 3 different lots with 1 month interval. All subjects received blood collection for immunogenicity test before and after primary immunization for evaluation of immunogenicity consistency, while safety observation was conducted within 30 days after each vaccination (30min via close safety monitoring, 0-7 days via participant diary card and 8-30 days via contact card for collection of adverse events) for safety evaluation of sIPV of 3 commercial lots.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Batch 1 of sIPV
Arm Type
Experimental
Arm Description
The first commercial batch of sIPV
Arm Title
Batch 2 of sIPV
Arm Type
Experimental
Arm Description
The second commercial batch of sIPV
Arm Title
Batch 3 of sIPV
Arm Type
Experimental
Arm Description
The third commercial batch of sIPV
Intervention Type
Biological
Intervention Name(s)
sIPV batch 1
Intervention Description
Type I 30 DU, Type II 32 DU, Type III 45 DU
Intervention Type
Biological
Intervention Name(s)
sIPV batch 2
Intervention Description
Type I 30 DU, Type II 32 DU, Type III 45 DU
Intervention Type
Biological
Intervention Name(s)
sIPV batch 3
Intervention Description
Type I 30 DU, Type II 32 DU, Type III 45 DU
Primary Outcome Measure Information:
Title
Seroconversion rate of neutralizing antibody
Description
Blood samples were collected before and after immunization. Seroconversion rate of serum neutralizing antibody was determined. Intergroup differences analysis of the post-immunization positive conversion and ≥4-fold increase rate of antibody was performed.
Time Frame
1 month after primary immunization
Title
Local and systemic adverse reactions
Description
Safety monitoring for local and systemic adverse reaction within 30 days after 3-dose primary immunization via close monitoring or diary card.
Time Frame
Within 1 month after primary immunization
Secondary Outcome Measure Information:
Title
GMT of neutralizing antibody
Description
Blood samples were taken before and after immunization for the determination of antibody level of serum neutralizing antibody. Intergroup differences analysis of antibody level was conducted.
Time Frame
1 month after primary immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy infants of 2 months of age The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card). Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation. Guardians are capable of using thermometer, graduated scale, filling diary card and contact card. Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment. Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample. Axillary temperature ≤37℃ Exclusion Criteria: Allergic to any active substance, inactive substance or materials used during production such as kanamycin. Patients with fever or acute disease. Have thrombocytopenia or hemorrhagic diseases Patients undergoing immunosuppressive therapy or immunodeficiency Have uncontrolled epilepsy or other progressive neurological disorders Other situations that the investigator consider as non-eligible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoqiang Liu
Organizational Affiliation
Disease prevention and control center of Yunnan province
Official's Role
Principal Investigator
Facility Information:
Facility Name
Disease prevention and control center of Yunnan province
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650022
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participants do not agree to share the individual data.
Citations:
PubMed Identifier
33487470
Citation
Jiang R, Liu X, Sun X, Wang J, Huang Z, Li C, Li Z, Zhou J, Pu Y, Ying Z, Yin Q, Zhao Z, Zhang L, Lei J, Bao W, Jiang Y, Dou Y, Li J, Yang H, Cai W, Deng Y, Che Y, Shi L, Sun M. Immunogenicity and safety of the inactivated poliomyelitis vaccine made from Sabin strains in a phase IV clinical trial for the vaccination of a large population. Vaccine. 2021 Mar 1;39(9):1463-1471. doi: 10.1016/j.vaccine.2021.01.027. Epub 2021 Jan 22.
Results Reference
derived

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Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain

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