Purified Inactivated Japanese Encephalitis Vaccine (NCT04223037) | Clinical Trial Compass
UnknownPhase 3
Purified Inactivated Japanese Encephalitis Vaccine
China1,050 participantsStarted 2015-09-01
Plain-language summary
This study evaluates the immunogenicity and safety of a purified inactivated JE vaccine compared to a commercialized JE vaccine. In this phase III, randomized, blind trial, infants at 6-23 months of age were randomly assigned to three groups to receive experimental vaccine or control vaccine with two different vaccination schedule respectively.
Who can participate
Age range6 Months ā 23 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 6-23 months old infants, no vaccination history of JE vaccine, no vaccination contraindication.
* informed consent of guardian / lawful written guardian, and signed informed consent;
* the guardian and family can comply with the requirements of the clinical trial scheme.
* there was no immunization history of immunoglobulins within three months, and there was no history of live vaccination within 14 days.
* the axillary temperature ⤠37ā.
Exclusion Criteria:
* Allergy to any ingredient in the vaccine (any previous history of vaccine allergy); There are allergic, convulsive, epileptic, encephalopathy and psychiatric symptoms or signs.
* People with known or suspected (or high-risk) impairment or abnormality of immune function, such as those receiving immunosuppressive or immunopotentiator therapy, receiving blood products or plasma extracts within three months, or having an immunodeficiency virus infection or related disease in the mother or child.
* A history of thrombocytopenia or other coagulation disorders clearly diagnosed by the medical department, or a history of hemorrhagic constitution or prolonged bleeding time;
* Infected patients with known or suspected to have respiratory diseases, acute infections or active chronic diseases and are receiving antibiotic or antiviral treatment;
* In the past 3 days, fever (axillary body temperatureā„38ā), oral or steroid hormones were given.
* Infectious or allergic skin diseases.
* Participating in another ā¦
What they're measuring
1
Local and systemic adverse reactions
Timeframe: Within 6 months after immunization
2
Immunogenecity detected by plaque reduction neutralization test