Chickenpox Vaccines
Conditions
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
Interventions
BIOLOGICALOka strain varicella attenuated live vaccine
lyophilized powder, subcutaneous injection
Sponsors
Jiangsu CDC
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
1 Years to 12 Years
Healthy volunteers
Yes
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.
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 titer (GMT) | 42 days after completing the full course of vaccination. | geometric mean titer (GMT) of VZV antibodies 42 days after vaccination |
| 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 |
Countries
China
Outcome results
None listed