NCT03147560

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 528 (actual)
• Sponsor: Zhejiang Provincial Center for Disease Control and Prevention · Other Government
• Sex: All
• Age: 60 Days – 75 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Polio

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	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.
BIOLOGICAL	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.

Timeline

• Start date: 2017-05-02
• Primary completion: 2017-12-30
• Completion: 2017-12-30
• First posted: 2017-05-10
• Last updated: 2019-09-12

Locations

2 sites across 1 country: China