Booster Dose of sIPV Co-administered With MMR and HepA-I.
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.
1 other identifier
interventional
889
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2024
CompletedFirst Posted
Study publicly available on registry
June 4, 2024
CompletedStudy Start
First participant enrolled
August 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2025
CompletedJanuary 16, 2026
May 1, 2024
1.1 years
May 29, 2024
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
seroconversion rates (SCRs) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)
-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
SCRs of anti-measles IgG antibodies 30 days after vaccination
30 days
SCRs of anti-mumps IgG antibodies
SCRs of anti-mumps IgG antibodies 30 days after vaccination
30 days
SCRs of anti-rubella IgG antibodies
SCRs of anti-rubella IgG antibodies 30 days after vaccination
30 days
SCRs of anti-hepatitis A IgG antibodies
SCRs of anti-hepatitis A antibodies 30 days after vaccination
30 days
Secondary Outcomes (8)
Seropositivity rates (SPRs) and GMC of anti-measles virus IgG antibodies
30 days
SPRs and GMC of anti-mumps virus IgG antibodies
30 days
SPRs and GMC of anti-rubella virus IgG antibodies
30 days
SPRs and GMC of anti- hepatitis A virus IgG antibodies
30 days
Geometric Mean Titer (GMT) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)
30 days
- +3 more secondary outcomes
Study Arms (5)
Trial group 1
EXPERIMENTALvaccination with sIPV+MMR
Trial group 2
EXPERIMENTALvaccination with sIPV+HepA-I
Control group 1
ACTIVE COMPARATORvaccination with sIPV
Control group 2
ACTIVE COMPARATORvaccination with MMR
Control group 3
ACTIVE COMPARATORvaccination with HepA-I
Interventions
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Nanjing, Jiangsu, 210009, China
Related Publications (1)
Hu J, Han W, Chu K, Zhang H, Tuo L, Duan X, Li J, Yuan F, Luan C, Pan H, Jiao P. Immunogenicity and Safety of Sabin Strain Inactivated Poliovirus Vaccine Booster Dose Administered Separately or Concomitantly with Inactivated Hepatitis A Vaccine or Measles-Mumps-Rubella Combined Attenuated Live Vaccine: An Open-Labelled, Randomized, Controlled, Phase 4 Clinical Trial. Vaccines (Basel). 2025 Oct 23;13(11):1087. doi: 10.3390/vaccines13111087.
PMID: 41295459DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pan Hongxing
Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2024
First Posted
June 4, 2024
Study Start
August 8, 2024
Primary Completion
September 10, 2025
Study Completion
October 10, 2025
Last Updated
January 16, 2026
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share