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Completed

NCT Number: NCT01817270

Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine

The purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.

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Key information

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xinxing Center for Disease Control and Prevention

Yunfu, Guangdong, China

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 aged ≥ 1 year to ≤ 3 years
  • Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
  • Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
  • Body temperature ≤ 37.5℃

Exclusion criteria

  • Known allergy to any constituent of the vaccine
  • Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
  • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
  • Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
  • Failed to the Expanded Programme on Immunization(EPI)
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Plan to receive any vaccine in the 4 weeks following the trial vaccination
  • Known bleeding disorder
  • Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination
  • Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination
  • An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
  • Participation in any other interventional clinical trial
  • 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

Live Attenuated Varicella Vaccine

Biological

Primary outcomes

  1. Seroconversion rate and GMTs for live attenuated varicella vaccine

    Time frame: 35-42 days after the first and second doses

Secondary outcomes

  1. Occurrence of adverse events

    Time frame: within 30 days after each vaccination

Sponsors and collaborators

Lead sponsor

Changchun Keygen Biological Products Co., Ltd.

Other

Collaborators

  • Guangdong Provincial Institute of Biological Products And Materia Medica

Registry information

Official study title

A Study to Evaluate the Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 25, 2013
Registry last updated
Oct 16, 2013

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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