Status:
RECRUITING
Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine
Lead Sponsor:
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Centers for Disease Control and Prevention, China
Conditions:
Hand, Foot and Mouth Disease
Eligibility:
All Genders
6-35 years
Phase:
PHASE4
Brief Summary
This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in 1500 chil...
Detailed Description
This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in children ...
Eligibility Criteria
Inclusion
- Age Requirement: Children aged 6 to 35 months at the time of enrollment.
- Provision of legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the study's requirements and complete relevant visits on time.
- Temperature Requirement: Axillary body temperature prior to vaccination is less than 37.3°C.
Exclusion
- \[First Dose Exclusion Criterions\] Subjects meeting any of the following exclusion criteria will not be eligible for enrollment
- Allergic History: Subjects have a previous history of allergies to any component of the vaccine (e.g., aluminum hydroxide, glycine), or previous or suspected allergy to any vaccine or other serious adverse reaction (e.g., anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction, dyspnea, angioedema, systemic rash and/or urticaria, etc.).
- Vaccination History: Subjects received any inactivated vaccine or subunit vaccine within 7 days prior to the first dose of the investigational vaccine or any live attenuated vaccine within 14 days prior to the first dose of the investigational vaccine.
- Neurological and Mental Health: Subjects with a history or family history of convulsion, epilepsy, encephalopathy, and psychosis.
- Health Conditions: Subjects with known severe congenital malformation or developmental disorder (e.g., Down syndrome, sickle cell anemia, congenital neurological disorders).
- Acute Illness: Subjects have experienced acute illness (e.g., fever) or acute onset of chronic illness within 3 days before the first dose of investigational vaccine, or use of antipyretic, analgesic, or antiallergic drugs within 3 days before the first dose of the investigational vaccine.
- Coagulation Abnormalities: Subjects with genetic bleeding tendency, coagulopathy, or a history of bleeding disorders.
- Organ Removal History: Subjects have a history of surgical removal of the spleen or other vital immune organs for any reason.
- Blood Conditions: Subjects with blood loss (≥400mL) or receipt of blood transfusion, immune globulin (other than hepatitis B immune globulin), or blood products within 3 months prior to the first dose of the investigational vaccine.
- Drug Administration: Subjects use any investigational or unregistered product (drug, biological product, or device) within 3 months prior to the first dose of the investigational vaccine, or planned use during the study, except the investigational vaccine.
- Immune Therapy: Subjects have a treatment with immunosuppressive agents within 6 months before the first dose of the investigational vaccine, such as long-term treatment with systemic glucocorticoids (e.g., prednisone or a similar agent for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) would be allowed.
- Previous history of receipt of other EV71 vaccines.
- Previous history of hand-foot-mouth disease.
- Immune-related Disease: Subjects have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus infection, etc.).
- Investigators' Discretion: The final exclusion criterion is the investigator's discretion to determine whether a subject is suitable for participation in the study.
- \[Contraindication of the second dose of vaccine\] Subjects meeting any of the following exclusion criteria will not be eligible for the second dose of the investigational vaccine
- Meeting allergic conditions that are mentioned in the First Dose Exclusion Criteria after the first dose.
- Severe Adverse Reactions: Subjects experienced serious adverse reactions after receiving the previous vaccine dose.
- Other Exclusion Reasons as Determined by the Investigator: The investigator determines other reasons for exclusion.
Key Trial Info
Start Date :
November 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2026
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06146088
Start Date
November 25 2023
End Date
July 15 2026
Last Update
January 3 2024
Active Locations (4)
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1
Chencang Center for Disease Prevention and Control
Baoji, Shaan XI, China
2
Ningqiang Center for Disease Prevention and Control
Hanzhong, Shaan XI, China
3
Fuping Center for Disease Prevention and Control
Weinan, Shaan XI, China
4
Jingyang Center for Disease Prevention and Control
Xianyang, Shaan XI, China