varicella
Conditions
Interventions
The first stage(13~17years old):The subjects aged from 13 to 17 years were vaccinated according to 0 and 8 weeks immunization program
The first stage(=18years old):The subjects aged =18 years were vaccinated according to 0 and 4 weeks immunization program
The first stage(13~17years old):The subjects aged from 13 to 17 years were vaccinated according to 0 and 4 weeks immunization program
The first stage(=18years old):The subjects aged =18 years were vaccinated according to 0 and 8 weeks immunization program
The second stage(13~17years old):The subjects aged from 13 to 17 years were vaccinated according to 0 and 4 weeks immunization program
The second stage(13~17years old):The subjects aged 13 ~ 17 years were vaccinated with control vaccine according to 0 and 4 weeks immunization program
The second stage(13~17years old):The subjects aged from 13 to 17 years were vaccinated according to 0 and 8 weeks immunization program
The second stage(13~17years old):The subjects aged 13 ~ 17 years were vaccinated with control vaccine according to 0 and 8 weeks immunization program
The second stage(=18years old):The subjects aged =18 years were vaccinated according to 0 and 4 weeks immunization program
The second stage(=18years old):The subjects aged =18 years were vaccinated with control vaccine according to 0 and 4 weeks immunization program
The second stage(=18years old):The subjects aged =18 years were vaccinated according to 0 and 8 weeks immunization program
The second stage(=18years old):The subjects aged =18 years were vaccinated with control vaccine according to 0 and 8 weeks immunization program
Sponsors
Jangsu Provincial Center For Disease Control And Prevention(Public Health Research Institute of Jiangsu Province)
Eligibility
Sex/Gender
All
Age
13 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Resident healthy people aged 13 years and above; (2) Obtain the informed consent of the volunteer and/or his/her legal guardian and sign the informed consent; (3) The volunteers and/or their legal guardians are able to comply with the requirements of the clinical trial protocol; (4) Armpit body temperature <= 37.0 ?.
Exclusion criteria
Exclusion criteria: (1) female urine pregnancy test positive, pregnant women, breastfeeding women, or women who plan to become pregnant within 3 months after the first dose to the full vaccination; (2) Have been vaccinated against chickenpox and have a history of chickenpox or herpes zoster infection; (3) People with a history of asthma, allergies to known components of the investigatory vaccine, and any previous history of severe allergy to vaccination (such as urticaria, dyspnea, and angioedema); (4) a history of epilepsy, convulsions or convulsions, or a family history of mental illness; (5) People with immune deficiency, immunosuppressant therapy (oral steroid hormones) or immunodeficiency due to HIV, or who have a congenital immune disease in their relatives; (6) Congenital malformations, developmental disorders or serious chronic conditions (e.g., Down syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain-Barre syndrome); (7) Known or suspected co-existing illnesses include: respiratory diseases, acute infections or active periods of chronic disease, cardiovascular diseases, skin diseases, severe hypertension, and treatment of malignant tumors; (8) A doctor's diagnosis of coagulation dysfunction (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or obvious bruising or coagulation disorder; (9) Have received blood products within the last 3 months; (10) Received live attenuated vaccine within the past 14 days or subunit or inactivated vaccine within the past 7 days; (11) Acute onset of various acute or chronic illnesses within the past 7 days; (12) High fever (armpit body temperature =38.0 ° C) in the past 3 days; (13) Plan to use salicylic acid or products containing salicylic acid within 6 weeks from the first dose of live attenuated varicella vaccine to the full dose of live attenuated varicella vaccine; (14) Researchers determine if the subjects have other factors that make them ineligible for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody positive conversion rate;antibody geometric mean titer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody positive conversion rate;antibody geometric mean titer;Geometric Mean fold Increase;Antibody positive conversion rate;antibody geometric mean titer;Geometric Mean fold Increase;Geometric Mean fold Increase;The proportion of antibodies greater than or equal to 1:128 ;Antibody positive conversion rate;antibody geometric mean titer;Geometric Mean fold Increase;Antibody positive conversion rate;antibody geometric mean titer;Geometric Mean fold Increase;Antibody positive conversion rate;antibody geometric mean titer;Geometric Mean fold Increase;The proportion of antibodies greater than or equal to 1:128 ;Antibody positive conversion rate;antibody geometric mean titer;Geometric Mean fold Increase;The proportion of antibodies greater than or equal to 1:128 ;antibody positive rate;antibody geometric mean titer;The proportion of antibodies greater than or equal to 1:128 ;antibody positive rate;antibody geometric mean titer;The proportion of antibodies greater than or equal to 1:128 ;antibody positive rate;antibody geometric mean titer;The proportion of antibodies greater than or equal to 1:128 ;Incidence and severity of adverse reactions;Incidence and severity of solicited adverse events;Incidence and severity of unsolicited adverse events;The incidence and severity of adverse events leading to withdrawal;Incidence and severity of serious adverse events; | — |
Countries
China
Contacts
Public ContactFengcai Zhu
Jangsu Provincial Center For Disease Control And Prevention(Public Health Research Institute of Jiangsu Province)
Outcome results
None listed