Clinical trial NCT06614816: Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years
Official title: Phase III Clinical Trial of Lyophilized Live Attenuated Varicella Vaccine for Children Aged 1-12 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chickenpox Vaccines
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Jiangsu CDC
First posted: 2024-09-26
Enrollment: 1200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study


Eligibility criteria: Inclusion Criteria:

* Ages ranging from 1 to 12 years for the general healthy population ;
* Obtain informed consent from the volunteer and/or their legal guardian, and sign the informed consent form;
* The volunteer and/or their legal guardian is able to comply with the requirements of the clinical trial protocol;
* Axillary body temperature ≤37.0℃.

Exclusion Criteria:

* Those who have previously been vaccinated against varicella, have a history of varicella or herpes zoster infection;
* Allergy to known components of the study vaccine, or a history of severe allergic reactions to any vaccination;
* A history of epilepsy, seizures, or convulsions, or a family history of psychiatric disorders;
* Individuals with immunodeficiency, undergoing immunosuppressive therapy (e.g., oral corticosteroids), or HIV-related immunocompromised individuals, or those with family members closely exposed to congenital immune diseases;
* Those with congenital malformations, developmental disorders, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome);
* Known or suspected concurrent diseases, including respiratory diseases, acute infections, or active chronic diseases, cardiovascular diseases, skin diseases, severe hypertension, or during treatment for malignant tumors;
* Diagnosed with coagulation dysfunction (e.g., deficiency of coagulation factors, coagulation disorders, platelet abnormalities) or significant bruising or coagulation disorders;
* Receipt of blood products within the past 3 months;
* Receipt of attenuated live vaccines within the past 14 days or subunit or inactivated vaccines within the past 7 days;
* Acute illnesses or acute exacerbations of chronic diseases in the past 7 days;
* A history of high fever (axillary body temperature ≥38.0℃) within the past 3 days;
* Any other factors deemed by the investigator as unsuitable for participation in the clinical trial.

Primary outcomes:
measure: seroconversion rate
timeFrame: 42 days after completing the full course of vaccination.
Secondary outcomes:
measure: geometric mean titer (GMT)
timeFrame: 42 days after completing the full course of vaccination.
measure: geometric mean fold increase (GMFI)
timeFrame: 42 days after completing the full course of vaccination.
Other outcomes:
Locations:
city: Huaian
country: China
facility: Huaiyin District Center for Disease Control and Prevention
state: Jiangsu
Study officials:
References: