A Phase 4 interventional study of sIPV and DTaP-IPV-Hib in Poliomyelitis, sponsored by Sinovac Biotech Co., Ltd. Recruiting at 3 sites in China. Open to participants aged 3 Months to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Sinovac Biotech Co., Ltd · Phase 4, Interventional, and Prevention
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
This study adopts a single-center, open-label, controlled design, planning to recruit 180 healthy participants, including 60 adolescents aged 7-17 years, 60 adults aged 18-50 years, and 60 infants aged 3 months. After being screened and enrolled, adolescents and adults aged 7-50 years will receive one dose of sIPV (inactivated poliovirus vaccine, Sabin strain) on Day 0, while infants aged 3 months will receive three doses of the pentavalent vaccine (DTaP-IPV-Hib) at 3, 4, and 5 months of age. Approximately 2.5-3.0 milliliters of venous blood will be collected from all participants before vaccination and on Day 30 after the last vaccination for antibody testing and immunogenicity evaluation. Researchers will observe participants for adverse events (AEs) within 30 minutes post-vaccination on-site and use diary cards to collect solicited and unsolicited AEs from Day 0 to Day 7 and AEs from Day 8 to Day 30 post-vaccination. Additionally, serious adverse events (SAEs) will be collected from the start of the first vaccination until Day 30 after the last vaccination. For fertile participants, pregnancy events for female participants themselves or the partners of male participants aged 18-50 years will be collected during the study period and after the first vaccination through a combination of active follow-up by researchers and self-reporting by participants.
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
This study's planned enrollment of 180 is below the median of 476 across 249 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
adolescents or adults aged 7-50 years
Biological: sIPV
infants aged 3 months old
Biological: DTaP-IPV-Hib
one dose of sIPV administered via intramuscular injection
three doses of DTaP-IPV-Hib administered via intramuscular injection following the schedule of 3,4,5 months old
The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 7-17 years
SCR indicates seroconversion rate；nab indicates neutralizing antibody
Time frame: 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
SCR indicates seroconversion rate; nab indicates neutralizing antibody
Time frame: 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
SCR indicates seroconversion rates; nab indicates neutralizing antibody
Time frame: day 30 after the single dose vaccination
The frequency of adverse reactions within 30 days after vaccination in participants aged 7-50 years
Time frame: 0-30 days after vaccination
The frequency of SAEs within 30 days after vaccination in participants aged 7-50 years
SAE indicates serious adverse events
Time frame: 0-30 days after vaccination
The frequency of adverse reactions within 30 days after vaccination in infants
Time frame: 0-30 days after vaccination
The frequency of SAEs within 30 days after vaccination in infants
SAE indicates serious adverse events
Time frame: 0-30 days after vaccination
The SPR of antibody against PT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
SPR indicates seropositivity rate; PT indicates pertussis toxin
Time frame: day 30 after three doses of vaccination
The SCR of antibody against PT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
SCR indicates seroconversion rates; PT indicates pertussis toxin
Time frame: day 30 after three doses of vaccination
The SPR of antibddy against DT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
SPR indicates seropositivity rate; DT indicates diphtheria toxin
Time frame: day 30 after three doses of vaccination
The SCR of antibody against DT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
SCR indicates seroconversion rate； DT indicates diphtheria toxin
Time frame: day 30 after three doses of vaccination
The SPR of antibody against TT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
SPR indicates seropositivity rate; TT indicates tetanus toxin
Time frame: day 30 after three doses of vaccination
The SCR of antibody against TT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
SCR indicates seroconversion rates; TT indicates tetanus toxin
Time frame: day 30 after three doses of vaccination
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Apr 2026, 6 months after the start.
Of 30 phase 4 interventional studies under Poliomyelitis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Poliovirus Vaccine, Inactivated