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Completed

NCT Number: NCT01684072

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

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.

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Key information

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chaoyang District Center for Disease Control and Prevention, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vaccine without gelatin

Biological

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

Biological

use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Primary outcomes

  1. To evaluate the immunogenicity of evaluated vaccine

    Time frame: 8 months

    The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.

Secondary outcomes

  1. To evaluate the safety of live attenuated varicella vaccine

    Time frame: 4 months

    The incidence of adverse events was analyzed statistically.

Sponsors and collaborators

Lead sponsor

Beijing Center for Disease Control and Prevention

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Sep 12, 2012
Registry last updated
Sep 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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