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

March 3, 2026 updated by: Sinovac Biotech Co., Ltd

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Iloilo City, Philippines
      • Imus, Philippines
        • Recruiting
        • Health Index Multispecialty Clinic - Research and Development on Medical Sciences
        • Contact:
    • Cavite
      • Kawit, Cavite, Philippines
        • Recruiting
        • Centennial Clindev Research and Development of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Infants of 2 months old (aged 56-84 days).
  2. Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
  3. Be able to provide the vaccination records since birth.
  4. 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).

Exclusion Criteria:

  1. History of any polio vaccination.
  2. History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component.
  3. Premature infants (born before week 37 of gestation).
  4. History of asphyxia rescue or nervous system injury.
  5. Congenital malformations, developmental disorders, clinically significant genetic defects, severe malnutrition.
  6. Autoimmune diseases or immunodeficiency/immunosuppression.
  7. Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders.
  8. Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders).
  9. Received immunosuppressant (excluding topical or inhaled corticosteroids), cytotoxic drug, or other immunomodulatory therapies.
  10. Received blood products before trial vaccine inoculation.
  11. Received other study drugs within 30 days before enrollment.
  12. Received live attenuated vaccines within 14 days before enrollment.
  13. Received subunit or inactivated vaccines within 7 days before enrollment.
  14. Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment.
  15. Significant acute diseases, chronic infections, or axillary temperature ≥ 37.5°C before enrollment.
  16. Any other factors deemed by the investigators as unsuitable for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2wIPV+1sIPV
First 2 doses: wIPV. 3rd dose: sIPV
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.
Experimental: 1wIPV+2sIPV
1st dose: wIPV. 2nd & 3rd doses: sIPV
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.
Active Comparator: 3wIPV
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.
Active Comparator: 3sIPV
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The SPR of nab against polioviruses of three types at day 28 after three doses of vaccination
Time Frame: day 28 after three doses of vaccination
SPR indicates seropositivity rate; seropositivity is defined as a nab titer ≥1:8
day 28 after three doses of vaccination
The frequency of adverse reactions within 28 days after vaccination
Time Frame: day 0-28 after vaccination
day 0-28 after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The SCR of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
Time Frame: day 28 after three doses of vaccination
SCR indicates seroconversion rat；nab indicates neutralizing antibody; seroconversion is defined as a fold increase in nab titer after vaccination for participants who are seropositive (≥1:8) at baseline, or a post-vaccination nab titer ≥1:8 for participants who are seronegative (<1:8) at baseline
day 28 after three doses of vaccination
The GMT of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
Time Frame: day 28 after three doses of vaccination
GMT indicates geometric mean titer
day 28 after three doses of vaccination
The GMFR of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
Time Frame: day 28 after three doses of vaccination
GMFR indicates geometric mean fold increase
day 28 after three doses of vaccination
The frequency of SAEs from the first vaccination to 28 days after the last vaccination
Time Frame: From the first vaccination to 28 days after the last vaccination
SAE indicates serious adverse events
From the first vaccination to 28 days after the last vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinovac Biotech Co., Ltd

Collaborators

Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2025

Primary Completion (Estimated)

September 8, 2026

Study Completion (Estimated)

October 19, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-sIPV-4005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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