NCT04386707

Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine

A Randomized, Double-blinded, Controlled Clinical Trial to Evaluate Lot Consistency, Immunogenicity and Safety of Sabin Inactivated Polio Vaccine (Vero Cell) in 2-month-old Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,300 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 60 Days – 89 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and evaluate the non-inferiority of investigational vaccine against a post-market inactivated polio vaccine.

Detailed description

This study is a randomized, double-blinded, and positive-controlled clinical trial. A total of 1300 infants aged 2 months will be enrolled and assigned to 4 groups in a ratio of 1:1:1:1 to receive vaccination of 3 lots of investigational sIPV and control IPV manufactured by Sanofi Pasteur S.A respectively. Each subjects should finish the three-doses primary vaccination at the schedule of 2,3,4 months of age. Thirty-days safety observation after each dose of vaccination will be carried out. Venous blood should be collected from all the subjects before and 30 days after the three-doses primary vaccination, for the neutralizing antibody assay, and further to evaluate the immunogenicity.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age	Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
BIOLOGICAL	Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age	Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
BIOLOGICAL	Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age	Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
BIOLOGICAL	Three doses control wIPV at the schedule of 2,3,4 months of age	Three doses control wIPV at the schedule of 2,3,4 months of age

Timeline

• Start date: 2020-05-11
• Primary completion: 2020-05-11
• Completion: 2020-10-20
• First posted: 2020-05-13
• Last updated: 2021-08-18

Locations

4 sites across 1 country: China