An Open-labelled, Randomized, Controlled, Clinical Trial to Evaluate the Immunogenicity and Tolerability of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 2 months
Healthy Volunteers: t
View:
• Infants of 2 months old (aged 56-84 days).
• Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
• Be able to provide the vaccination records since birth.
• The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C during or before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).
Locations
Other Locations
Philippines
Iloilo Doctors' Hospital
RECRUITING
Iloilo City
Health Index Multispecialty Clinic - Research and Development on Medical Sciences
RECRUITING
Imus
Centennial Clindev Research and Development of Medical Sciences
RECRUITING
Kawit
Time Frame
Start Date: 2025-11-27
Estimated Completion Date: 2026-10-19
Participants
Target number of participants: 480
Treatments
Experimental: 2wIPV+1sIPV
First 2 doses: wIPV. 3rd dose: sIPV
Experimental: 1wIPV+2sIPV
1st dose: wIPV. 2nd \& 3rd doses: sIPV
Active_comparator: 3wIPV
Active_comparator: 3sIPV
Related Therapeutic Areas
Sponsors
Collaborators: Aga Khan University
Leads: Sinovac Biotech Co., Ltd