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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yunnan
      • Kunming, Yunnan, China, 650022
        • Disease prevention and control center of Yunnan province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 3 months (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Batch 1 of sIPV
The first commercial batch of sIPV
Type I 30 DU, Type II 32 DU, Type III 45 DU
Experimental: Batch 2 of sIPV
The second commercial batch of sIPV
Type I 30 DU, Type II 32 DU, Type III 45 DU
Experimental: Batch 3 of sIPV
The third commercial batch of sIPV
Type I 30 DU, Type II 32 DU, Type III 45 DU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rate of neutralizing antibody
Time Frame: 1 month after primary immunization
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.
1 month after primary immunization
Local and systemic adverse reactions
Time Frame: Within 1 month after primary immunization
Safety monitoring for local and systemic adverse reaction within 30 days after 3-dose primary immunization via close monitoring or diary card.
Within 1 month after primary immunization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GMT of neutralizing antibody
Time Frame: 1 month after primary immunization
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.
1 month after primary immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xiaoqiang Liu, Disease prevention and control center of Yunnan province

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2018

Primary Completion (Actual)

February 25, 2019

Study Completion (Actual)

October 12, 2019

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants do not agree to share the individual data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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