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

Launched by SINOVAC BIOTECH CO., LTD · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to study the safety and effectiveness of a booster dose of a specific poliovirus vaccine, called sIPV, when given together with vaccines for measles, mumps, rubella (MMR), and hepatitis A (HepA). The goal is to see how well this combination of vaccines works and if it is safe for young children. The trial is currently not recruiting participants, but it will focus on healthy toddlers aged 18 months to 6 years who have already received the necessary initial doses of the poliovirus and MMR vaccines.

To participate, children must meet certain criteria, such as being healthy, having proof of their vaccinations, and having guardians who can understand and agree to the study. However, children with a history of certain medical conditions, allergies to vaccines, or who have received other vaccines recently may not be eligible. If selected, participants can expect to receive the booster vaccine and will be monitored for any side effects or reactions. This trial is important as it will help improve our understanding of how to keep children protected against these diseases.

Gender

ALL

Eligibility criteria

• 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.