NCT06752174

A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants

A Randomized, Blinded, Parallel Positive-controlled Clinical Trial of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Beijing Minhai Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 60 Days – 90 Days
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.

Detailed description

A total of approximately 300 infants 2 months of age (over 60 days old and less than 90 days old) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 150 participants in each group.The study group will receive study sIPV developed by Biominhai and control group will receive wIPV developed by SANOFI PASTEUR S.A. The "2+1 sequential" procedure consists of 2 doses of inactivated vaccine (sIPV or wIPV) and 1 dose of bOPV, a total of 3 doses, with 1 month between each vaccination. This study has indicated that the sIPV is not inferior to the wIPV in terms of immunogenicity and safety according to the "2+1 sequential" immunization program in 2-month-old healthy infants.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	sIPV+bOPV	2+1 sequential" immunization program (sIPV-sIPV-bOPV)
BIOLOGICAL	wIPV+bOPV	2+1 sequential" immunization program (wIPV-wIPV-bOPV)

Timeline

• Start date: 2023-03-08
• Primary completion: 2024-04-12
• Completion: 2024-04-12
• First posted: 2024-12-30
• Last updated: 2024-12-30

Locations

1 site across 1 country: China