Booster Dose of sIPV Co-administered With MMR and HepA-I.

January 14, 2026 updated by: Sinovac Biotech Co., Ltd

Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of sIPV Co-administered With MMR and HepA-I.

This is an Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of Sabin Strain Inactivated Poliovirus Vaccine (Vero cell) (sIPV) Co-administered with Measles, Mumps, Rubella (MMR) Combined Live Attenuated Vaccine and Inactivated Hepatitis A (Hep-A) Vaccine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The trial plans to enroll 960 infants aged 18 months (+4 months) who had completed three primary doses of sIPV vaccine and were assigned in a 2:2:2:1:1 ratio to four groups including trial group 1, trial group 2, control group 1, control group 2, control group 2, with informed consent from the participant's guardian. Trial group 1 receive one dose of sIPV co-administered with one dose of MMR vaccine. Trial group 2 receive one dose of sIPV co-administered with one dose of inactivated hepatitis A vaccine. Control group 1 receive one dose of sIPV, control group 2 receive one dose of MMR vaccine, and control group 3 receive one dose of inactivated hepatitis A vaccine. About 3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination for antibody detection. Immediate reactions will be observed for 30 minutes after vaccination, and adverse events occured from 0 to day 30 after vaccination will be collected.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
889

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • (1) healthy toddlers aged 18 months (+4 months);
  • (2) completed three doses of sIPV primary immunization;
  • (3) completed one dose of MMR vaccination;
  • (4) able to provide proof of vaccination;
  • (5) able to provide legal proof of identity;
  • (6) The guardians of the participants were able to understand and agree to sign the informed consent.

Exclusion Criteria:

  • (1) a history of vaccination with a polio-containing vaccine component in addition to three sIPV primary doses, according to the vaccination certificate;
  • (2) have received a second dose of MMR vaccine or a vaccine containing a vaccine for measles, mumps or rubella, or hepatitis A vaccine (inactivated or attenuated), according to the vaccination certificate;
  • (3) previous history of polio or measles or mumps or rubella or hepatitis A;
  • (4) known severe allergy to the vaccine or vaccine components, such as urticaria, dyspnea, angioedema;
  • (5) severe congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
  • (6) with autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, asplenia, functional asplenia, and HIV infection);
  • (7) abnormal coagulation function (such as coagulation factor deficiency, platelet abnormality), or obvious bleeding, hematoma, or ecchymosis after previous intramuscular injection or venipuncture;
  • (8) have/have had a serious neurological disease (e.g., encephalopathy, epilepsy, convulsions [other than febrile convulsions]) or psychosis, a family history of neurological disease or psychosis;
  • (9) receiving immunosuppressive or other immunomodulatory therapy, cytotoxic therapy within the past 6 months, or planning to receive such treatment during the trial;
  • (10) have received an immune globulin or other blood products within the past 6 months or plan to receive such treatment during the trial;
  • (11) receipt of other investigational vaccines within 30 days before vaccination with the investigational vaccines;
  • (12) receipt of live attenuated vaccine within 28 days before vaccination with the investigational vaccine;
  • (13) receipt of subunit or inactivated vaccine within 7 days before vaccination with the investigational vaccine;
  • (14) acute diseases or acute episodes of chronic diseases within the past 7 days;
  • (15) Axillary temperature >37.0℃ if fever occurred before vaccination;
  • (16) which are unsuitable for participation in the clinical trial as judged by the investigators.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Trial group 1
vaccination with sIPV+MMR
Biological: sIPV
vaccination with sIPV
Biological: MMR
vaccination with MMR
Experimental: Trial group 2
vaccination with sIPV+HepA-I
Biological: sIPV
vaccination with sIPV
Biological: HepA-I
vaccination with HepA-I
Active Comparator: Control group 1
vaccination with sIPV
Biological: sIPV
vaccination with sIPV
Active Comparator: Control group 2
vaccination with MMR
Biological: MMR
vaccination with MMR
Active Comparator: Control group 3
vaccination with HepA-I
Biological: HepA-I
vaccination with HepA-I

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
seroconversion rates (SCRs) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)
Time Frame: 30 days
-The SCRs of neutralizing antibody against different poliovirus serotypes (Type I, II and III) at day 30 after sIPV vaccination.
30 days
SCRs of anti-meascles IgG antibodies
Time Frame: 30 days
SCRs of anti-measles IgG antibodies 30 days after vaccination
30 days
SCRs of anti-mumps IgG antibodies
Time Frame: 30 days
SCRs of anti-mumps IgG antibodies 30 days after vaccination
30 days
SCRs of anti-rubella IgG antibodies
Time Frame: 30 days
SCRs of anti-rubella IgG antibodies 30 days after vaccination
30 days
SCRs of anti-hepatitis A IgG antibodies
Time Frame: 30 days
SCRs of anti-hepatitis A antibodies 30 days after vaccination
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Seropositivity rates (SPRs) and GMC of anti-measles virus IgG antibodies
Time Frame: 30 days
SPRs and GMC of anti-measles virus IgG antibodies 30 days after vaccination.
30 days
SPRs and GMC of anti-mumps virus IgG antibodies
Time Frame: 30 days
SPRs and GMC of anti-mumps virus IgG antibodies 30 days after vaccination;
30 days
SPRs and GMC of anti-rubella virus IgG antibodies
Time Frame: 30 days
SPRs and GMC of anti-rubella virus IgG antibodies 30 days after vaccination;
30 days
SPRs and GMC of anti- hepatitis A virus IgG antibodies
Time Frame: 30 days
SPRs and GMC of anti- hepatitis A virus IgG antibodies 30 days after vaccination;
30 days
Geometric Mean Titer (GMT) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)
Time Frame: 30 days
-GMTs of antibody of neutralizing antibody against different poliovirus serotypes (Type I, II and III) at day 30 after sIPV vaccination;
30 days
- SPRs of neutralizing antibodies against different poliovirus serotypes (Type I, II and III)
Time Frame: 30 days
- SPRs of neutralizing antibodies against different poliovirus serotypes (Type I, II and III) at day 30 after vaccination.
30 days
- Incidence of adverse reactions (ARs)
Time Frame: 30 days
- Incidence of ARs from 0 to 30 days after vaccination;
30 days
- Incidence of serious adverse events (SAEs)
Time Frame: 30 days
- Incidence of SAEs 0~30 days after vaccination.
30 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac Biotech Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pan Hongxing, Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-sIPV-4003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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