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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01684072
First received: September 9, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chickenpox
Zoster
Biological: vaccine without gelatin
Biological: vaccine with gelatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin

Resource links provided by NLM:


Further study details as provided by Beijing Center for Disease Control and Prevention:

Primary Outcome Measures:
  • To evaluate the immunogenicity of evaluated vaccine [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.


Secondary Outcome Measures:
  • To evaluate the safety of live attenuated varicella vaccine [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    The incidence of adverse events was analyzed statistically.


Enrollment: 1200
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Biological: 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
Active Comparator: 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
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
Biological: 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684072

Locations
China, Beijing
Chaoyang District Center for Disease Control and Prevention
Beijing, Beijing, China
China, Hebei
Sanhe Center for Disease Control and Prevention
Langfang, Hebei, China
China, Inner Mongolia
Jiuyuan Center for Disease Control and Prevention
Baotou, Inner Mongolia, China
Sponsors and Collaborators
Beijing Center for Disease Control and Prevention
Investigators
Study Chair: Nianmin Shi Beijing Chaoyang District Center for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01684072     History of Changes
Other Study ID Numbers: BJCDPC-2
Study First Received: September 9, 2012
Last Updated: September 9, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Center for Disease Control and Prevention:
varicella vaccine
gelatin

Additional relevant MeSH terms:
Chickenpox
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014