NCT07457060

Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 56 Days – 84 Days
• Healthy volunteers: Accepted

Summary

The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes

Detailed description

This is an open-labelled, randomized, controlled clinical trial. Totally 480 healthy infants of 2 months old (aged 56-84 days) are planned to be enrolled, and then randomized in a 1:1:1:1 ratio into four groups (group A, B, C, D). Group A-D will receive three doses of primary immunization against polio as per the 2wIPV+1sIPV (First 2 doses: wIPV. 3rd dose: sIPV), 1wIPV+2sIPV (1st dose: wIPV. 2nd \& 3rd doses: sIPV), 3wIPV, 3sIPV vaccination regimen, with an interval of 28 days (+14 days) between doses. In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections. For all the participants, the immediate reactions within 30 minutes after each dose of vaccination will be observed on study site. Guardians of participants will utilize the diary card to record adverse events (AEs) from the time of vaccination for 7 days after each dose of vaccination, and will utilize the diary card to record any AEs from 8 days up to 28 days after each dose of vaccination. SAEs arise from the time of vaccination up to 28 days after the last vaccination will be collected. About 3.0 ml venous blood will be collected before the first vaccination and 28 days (+14 days) after the last vaccination. Neutralizing antibody (Nab) titer against polioviruses of three serotypes will be determined for immunogenicity evaluation. Approximately 5.0 ml of venous blood will be drawn from the mothers to test for these disease infections. Alternatively, mothers may provide relevant test results obtained during pregnancy for these infections. This approach will enable the investigators to identify any potential perinatal transmission to the infant and offer appropriate guidance and management for both the mother and the child.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	2wIPV+1sIPV	First 2 doses: wIPV. 3rd dose: sIPV In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
BIOLOGICAL	1wIPV+2sIPV	1st dose: wIPV. 2nd \& 3rd doses: sIPV In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
BIOLOGICAL	3wIPV	three doses of wIPV with an interval of 28 days (+14 days) between doses; In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
BIOLOGICAL	3sIPV	Three doses of sIPV with an interval of 28 days (+14 days) between doses. In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.

Timeline

• Start date: 2025-11-27
• Primary completion: 2026-09-08
• Completion: 2026-10-19
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

3 sites across 1 country: Philippines