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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01684072
Other study ID # BJCDPC-2
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2012
Last updated September 9, 2012
Start date January 2011
Est. completion date January 2012

Study information

Verified date September 2012
Source Beijing Center for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody,Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.


Description:

Observational Objectives:

To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.

To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date January 2012
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 12 Years
Eligibility Inclusion Criteria:

- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent

- Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local = 12 months

- Participant is aged = 1 year to = 12 years

- Body temperature = 37.0?

- Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster

Exclusion Criteria:

- Known allergy to any constituent of the vaccine

- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction

- Known bleeding disorder

- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth

- Participation in any other interventional clinical trial

- An acute illness with or without fever (temperature > 37.0?) in the latest week preceding enrollment in the trial

- Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study

- Reported clearly the infection of the upper respiratory tract with 6 months

- Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor

- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
vaccine without gelatin
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
vaccine with gelatin
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Locations

Country Name City State
China Jiuyuan Center for Disease Control and Prevention Baotou Inner Mongolia
China Chaoyang District Center for Disease Control and Prevention Beijing Beijing
China Sanhe Center for Disease Control and Prevention Langfang Hebei

Sponsors (1)

Lead Sponsor Collaborator
Beijing Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the immunogenicity of evaluated vaccine The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody. 8 months No
Secondary To evaluate the safety of live attenuated varicella vaccine The incidence of adverse events was analyzed statistically. 4 months Yes
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