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

Zhejiang Provincial Center for Disease Control and Prevention2 sites in 1 country528 target enrollmentMay 2, 2017

ConditionsPolio

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Polio
Sponsor: Zhejiang Provincial Center for Disease Control and Prevention
Enrollment: 528
Locations: 2
Primary Endpoint: seroconversion rate
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2, 2017

End Date

December 30, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhejiang Provincial Center for Disease Control and Prevention

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

neutralizing antibody titer(Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.)
safety: 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.)