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

Zhejiang Provincial Center for Disease Control and Prevention

Status and phase: Completed; Phase 4

Conditions: Polio

Treatments: Biological: Sabin IPV + Sabin IPV + Sabin IPV; Biological: Sabin IPV + Sabin IPV + bOPV; Biological: Sabin IPV+ bOPV+ bOPV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03147560

ZJCDC20170508

Details and patient eligibility

About

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.

Enrollment: 528 patients

Sex: All

Ages: 60 to 75 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

528 participants in 3 patient groups

Group 1

Experimental group

Description:

The sequential immunization strategy for group 1 on polio was Sabin IPV+ bOPV + bOPV.

Treatment:

Biological: Sabin IPV+ bOPV+ bOPV

Group 2

Experimental group

Description:

The sequential immunization strategy for group 2 on polio was Sabin IPV + Sabin IPV + bOPV.

Treatment:

Biological: Sabin IPV + Sabin IPV + bOPV

Group 3

Experimental group

Description:

The sequential immunization strategy for group 3 on polio was Sabin IPV + Sabin IPV + Sabin IPV.

Treatment:

Biological: Sabin IPV + Sabin IPV + Sabin IPV