Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin

Chickenpox Clinical Trial

Official title:

Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684072
• Other study ID #: BJCDPC-2
• 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

• Chickenpox
• Zoster

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