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COMPLETEDPHASE4

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.

NCT06442449•Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

1 - 1 years

Sex

ALL

Healthy Volunteers

Yes

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;
+6 more criteria

Locations (1)

Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)

Nanjing, Jiangsu, China

Key Dates

Start Date

August 8, 2024

Primary Completion Date

September 10, 2025

Completion Date

October 10, 2025

Last Updated

January 16, 2026

Enrollment

889

ACTUAL participants

Conditions

Poliomyelitis

Interventions

sIPV

BIOLOGICAL

MMR

BIOLOGICAL

HepA-I

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease

Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants

Sequential Vaccination of Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains From Different Manufacturers