Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants

The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.

Study Overview

Study Type

Interventional

Enrollment (Actual)

528

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

    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Chunan Center for Disease Control and Prevention
      • Quzhou, Zhejiang, China
        • longyou Center for Disease Control and Prevention

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

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
  • Participant is aged ≥ 60 days to ≤ 75 days.
  • Participant without preventive inoculation of polio vaccine and previous history of Polio.
  • Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
  • Body temperature ≤ 37.5℃.

Exclusion Criteria:

  • Known allergy to any constituent of the vaccine.
  • Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
  • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
  • Known bleeding disorder.
  • Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.
  • Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.
  • An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial.
  • Participation in any other intervention clinical trial.
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
The sequential immunization strategy for group 1 on polio was Sabin IPV+ bOPV + bOPV.
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
Experimental: Group 2
The sequential immunization strategy for group 2 on polio was Sabin IPV + Sabin IPV + bOPV.
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
Experimental: Group 3
The sequential immunization strategy for group 3 on polio was Sabin IPV + Sabin IPV + Sabin IPV.
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
seroconversion rate
Time Frame: seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.
any positive antibody response in infants who were seronegative prior to their first dose, or at least a fourfold increase in type-specific antibody levels for infants who had pre-existing antibodies.
seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety: rate of adverse events
Time Frame: At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.
the rate of adverse events.
At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.
neutralizing antibody titer
Time Frame: Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.
Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.

Collaborators and Investigators

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

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)

May 2, 2017

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ZJCDC20170508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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