Chickenpox Vaccines
Conditions
Keywords
clinical trial, phase 3, Immunogenicity, Safety, Live Attenuated Varicella Vaccine
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
Interventions
BIOLOGICALChickenpox Vaccines
The vaccines require reconstitution with the provided sterile water for injection nd should be shaken well before use. Each human dose (0.5 ml) contains at least 3.3 log PFU of VZV.
Sponsors
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| seroconversion rate | 42 days after completing the full course of vaccination | The primary immunogenicity endpoint was the seroconversion rate of VZV antibodies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| geometric mean fold increase (GMFI) | 42 days after completing the full course of vaccination | geometric mean fold increase (GMFI) of VZV antibodies 42 days after vaccination |
| geometric mean titer (GMT) | 42 days after completing the full course of vaccination | geometric mean titer (GMT) of VZV antibodies 42 days after vaccination |
Countries
China
Outcome results
None listed