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Phase III clinical trial for live attenuated varicella vaccine

Randomized, blind, non-inferior clinical trial of immunogenicity, safety and immune persistence of live attenuated varicella vaccine in people aged 1 to 12 years

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020665
Enrollment
Unknown
Registered
2019-01-12
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

varicella

Interventions

1-3 years old:Injected with Varicella vaccine
4-6 years old:Injected with Varicella vaccine

Sponsors

Guizhou Center for Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Aged 1 to 12 years, and legal identity certificate is provided; 2. The legal guardian of the subject (and the subject himself) shall sign the informed consent and the date of signature (8-12 year-old subjects need to sign the informed notification and their legal guardian shall sign the informed consent); 3. Subaxillary body temperature < 37.0 C.

Exclusion criteria

Exclusion criteria: 1. Those who had been vaccinated with live attenuated varicella vaccine or had a history of varicella and herpes zoster virus infection before admission to the group; 2. Those who are allergic to any component of the vaccine (including sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate, sucrose, sodium glutamate, erythromycin) have any previous history of severe allergy to vaccination; 3. Persons with encephalopathy, uncontrolled epilepsy and other progressive neurological diseases or family history; 4. Patients with immunodeficiency, malignant tumors, immunosuppressive therapy (oral steroids, etc.) or HIV-induced immunodeficiency, among whom are family members with congenital immune diseases; 5. Injection of non-specific immunoglobulin or any blood product within 3 months before admission, or planned use during the trial (before blood sample collection after immunization); 6. Long-term use of immunosuppressive agents or other immunomodulatory drugs (defined as continuous use for more than 14 days) within the first three months of admission, such as the dose of glucocorticoids at 30.5 mg/kg/day (inhalation and-topical steroid hormones are not restricted); 7. Salicylates (mainly salicylic acid, aspirin, diflunisal, p-aminosalicylic acid (sodium), bissalicylic ester and benzoate) are currently being used or are planned to be used for a long time during the study period; 8. Vaccination intervals of live attenuated vaccines are less than 30 days and other vaccines are less than 14 days; 9. Persons with body temperature > 37.0 C or current infectious, febrile and other acute diseases; 10. A history of clearly diagnosed thrombocytopenia or other coagulation disorders may lead to contraindication of subcutaneous injection; 11. Known or suspected to suffer from: severe respiratory diseases (including pneumonia, tuberculosis, severe asthma, chronic bronchitis, etc.), acute infections, severe chronic diseases or acute episodes of chronic diseases; 12. He is suffering from serious cardiovascular, liver, kidney and other important organ diseases, diabetes and other serious systemic diseases; 13. Asymptomia, functional asymptomia, and acquired asymptomia or splenectomy in any case; 14. Infectious or allergic skin diseases; 15. Researchers believe that any situation that may affect the evaluation of the trial (e.g. extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss, etc.).

Design outcomes

Primary

MeasureTime frame
Positive Conversion Rate of Varicella Virus Antibody;

Countries

China

Contacts

Public ContactShiguang Lei

Guizhou Center for Disease Control and Prevention

948488961@qq.com+86 13809486719

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026