A Phase 4 interventional study of sIPV in Poliomyelitis, sponsored by Sinovac Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged Up to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Sinovac Biotech Co., Ltd · Phase 4, Interventional, and Prevention
To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV.
In this study, two hundred infants ≤ 12 months of age vaccinated with two doses of sIPV produced by Beijing Institute of Biological Products Co., Ltd., will be enrolled with a balanced male-to-female ratio. After enrollment with informed consent from the guardians of the participants, they will be divided into two groups, i.e., the study group and the control group, according to the 1:1 ratio. They will be vaccinated with one dose of the sIPV produced by Sinovac or the sIPV produced by Beijing Institute, respectively. The 30-minute observation will be conducted after the vaccination. Immediate reactions will be observed and solicited adverse events within 0-7 days, while unsolicited adverse events within 0-30 days will be collected to evaluate vaccine safety. About 2.5-3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination, and anti-poliovirus type 1, type 2, and type 3 neutralizing antibody tests will be performed to evaluate immunogenicity.
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
This study's enrollment of 200 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.
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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.
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.
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.
sIPV: Sinovac Biotech Co., Ltd., Beijing
Biological: sIPV
sIPV: Beijing Institute of Biological Products Co., LTD.
Biological: sIPV
One dose of the experimental/control vaccine will be administered to 4-month-old infants who have already received two doses of sIPV from Beijing Institute of Biological Products Co., LTD.
Geometric Mean Increase (GMI)
-The neutralizing antibody GMI against different types (Type I, II and III) at day 30 after vaccination;
Time frame: 30 days
Geometric Mean Titer (GMT)
-The neutralizing antibody GMT against different types (Type I, II and III) at day 30 after vaccination;
Time frame: 30 days
Seropositivity rate
-The seropositivity rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
Time frame: 30 days
Seroconversion rate
-The seroconversion rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
Time frame: 30 days
Adverse reaction incidence
-The incidence of adverse reaction within 30 days after vaccination;
Time frame: 30 days
Serious adverse events incidence
-The incidence of serious adverse events within 30 days after vaccination.
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2024 to primary completion in Sep 2024, 3 months.
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 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Poliovirus Vaccine, Inactivated