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

Phase 4

Completed

• Conditions: Polio
• Interventions: Biological: Sabin IPV+ bOPV+ bOPV; Biological: Sabin IPV + Sabin IPV + Sabin IPV; Biological: Sabin IPV + Sabin IPV + bOPV

• Registration Number: NCT03147560
• Lead Sponsor: Zhejiang Provincial Center for Disease Control and Prevention

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 528

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Sabin IPV+ bOPV+ bOPV	The sequential immunization strategy for group 1 on polio was Sabin IPV+ bOPV + bOPV.
Group 3	Sabin IPV + Sabin IPV + Sabin IPV	The sequential immunization strategy for group 3 on polio was Sabin IPV + Sabin IPV + Sabin IPV.
Group 2	Sabin IPV + Sabin IPV + bOPV	The sequential immunization strategy for group 2 on polio was Sabin IPV + Sabin IPV + bOPV.

Primary Outcome Measures

Name	Time	Method
seroconversion rate	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 Outcome Measures

Name	Time	Method
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.	the rate of adverse events.

Trial Locations

Locations (2)

Chunan Center for Disease Control and Prevention; 🇨🇳 Hangzhou, Zhejiang, China

Longyou Center for Disease Control and Prevention; 🇨🇳 Quzhou, Zhejiang, China