Clinical trial NCT06592456: A Phase III Clinical Trial Assessing the Immunogenicity and Safety of Lyophilized Live-Attenuated Varicella Vaccine in Healthy Subjects Aged 13 to 55 Years
Official title: Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Adolescents and Adults Aged Between 13 to 55 Years : a Double-Blind, Randomized, Parallel-Controlled Phase III Clinical Trial in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chickenpox Vaccines
Keywords: clinical trial
phase 3
Immunogenicity
Safety
Live Attenuated Varicella Vaccine
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Adolescents and adults Aged 13-55 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study


Eligibility criteria: Inclusion Criteria:

* Healthy individuals aged between 13 to 55 years who are permanent residents; Have obtained informed consent from the volunteer and/or their legal guardian, and signed the informed consent form; The volunteer and/or their legal guardian can comply with the requirements of the clinical trial protocol; Axillary temperature ≤37.0°C.

Exclusion Criteria:

* Females aged 18 to 55 years with a positive urine pregnancy test, pregnant women, women who are breastfeeding, or women planning to become pregnant within the next 3 months; Have a history of varicella vaccination, a history of chickenpox, or a history of herpes zoster infection; Allergic 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 having HIV-related immunocompromised status, or having close family members with congenital immune diseases; Have 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 (such as coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders; Have received blood products in the past 3 months; Have received live attenuated vaccines in the past 14 days or subunit or inactivated vaccines in the past 7 days; Have had various acute diseases or acute exacerbations of chronic diseases in the past 7 days; Have had a fever (axillary temperature ≥38.0°C) in 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: