RecruitingPhase 4

Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations

China180 participantsStarted 2025-09-26

Plain-language summary

The goal of this clinical study is to compare the immunogenicity and safety of one dose of sIPV in adolescents or adults aged 7-50 years with that of three doses of DTaP-IPV-Hib Pentavalent Vaccine in Infants Aged 3 Months

Who can participate

Age range

3 Months – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months;
. Participants and/or their guardians are able to understand and voluntarily sign the informed consent form (for participants aged 7-17 years, both the participant and their guardian need to sign);
. Provide valid proof of identity;
. Willing and able to comply with all visit schedules, sample collections, vaccinations, and other study procedures, and remain contactable throughout the study period;
. Fertile participants and their sexual partners voluntarily adopt effective contraceptive measures from the signing of the informed consent form until 3 months after vaccination with the study vaccine, and have no plans to donate sperm or eggs.

Exclusion criteria

. Known history of polio/polio infection.
. Exposure or suspected exposure to pertussis, diphtheria, and tetanus within the past 30 days, such as having a confirmed case of pertussis or diphtheria in the household (applies to infants aged 3 months).
. History of uncontrolled chronic or severe illnesses, including but not limited to cardiovascular disease, hematological disorders, liver and kidney diseases, digestive system diseases, respiratory diseases, malignant tumors, and history of major organ transplantation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 7-17 years

Timeframe: day 30 after the single dose vaccination

The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 18-50 years

Timeframe: day 30 after the single dose vaccination

The SCR of nab against three serotypes of polioviruses at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months

Timeframe: day 30 after the single dose vaccination

Trial details

NCT IDNCT07354269

SponsorSinovac Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-11

Contact for this trial

Xiaoshu Zhang

86-0931-8277391 zhxs000@126.com

View on ClinicalTrials.gov More Poliomyelitis trials

Who can participate

Age range

3 Months – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months;
. Participants and/or their guardians are able to understand and voluntarily sign the informed consent form (for participants aged 7-17 years, both the participant and their guardian need to sign);
. Provide valid proof of identity;
. Willing and able to comply with all visit schedules, sample collections, vaccinations, and other study procedures, and remain contactable throughout the study period;
. Fertile participants and their sexual partners voluntarily adopt effective contraceptive measures from the signing of the informed consent form until 3 months after vaccination with the study vaccine, and have no plans to donate sperm or eggs.

Exclusion criteria

. Known history of polio/polio infection.
. Exposure or suspected exposure to pertussis, diphtheria, and tetanus within the past 30 days, such as having a confirmed case of pertussis or diphtheria in the household (applies to infants aged 3 months).
. History of uncontrolled chronic or severe illnesses, including but not limited to cardiovascular disease, hematological disorders, liver and kidney diseases, digestive system diseases, respiratory diseases, malignant tumors, and history of major organ transplantation.

What they're measuring

The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 7-17 years

Timeframe: day 30 after the single dose vaccination

The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 18-50 years

Timeframe: day 30 after the single dose vaccination

The SCR of nab against three serotypes of polioviruses at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months

Timeframe: day 30 after the single dose vaccination