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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
889
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Trial group 1
vaccination with sIPV+MMR
|
vaccination with sIPV
vaccination with MMR
|
|
Experimental: Trial group 2
vaccination with sIPV+HepA-I
|
vaccination with sIPV
vaccination with HepA-I
|
|
Active Comparator: Control group 1
vaccination with sIPV
|
vaccination with sIPV
|
|
Active Comparator: Control group 2
vaccination with MMR
|
vaccination with MMR
|
|
Active Comparator: Control group 3
vaccination with HepA-I
|
vaccination with HepA-I
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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.
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)
August 8, 2024
Primary Completion (Actual)
September 10, 2025
Study Completion (Actual)
October 10, 2025
Study Registration Dates
First Submitted
May 29, 2024
First Submitted That Met QC Criteria
May 29, 2024
First Posted (Actual)
June 4, 2024
Study Record Updates
Last Update Posted (Estimated)
January 16, 2026
Last Update Submitted That Met QC Criteria
January 14, 2026
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.