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Completed

NCT Number: NCT01062061

Re-examination Study For Varivax (V210-059 AM2)

This survey is conducted for preparing application materials for re-examination under the Korean Pharmaceutical Affairs Laws and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of VARIVAX through collecting the safety information according to the Re-examination Regulation for New Drugs.

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Key information

Conditions

Varicella Chickenpox DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

12 month and older

Sex eligibility

All sexes

Study type

Observational

About this study

This post-marketing survey was conducted in the usual routine practice and the investigator enrolled participants vaccinated with VARIVAX continuously after study start. The purpose of the study was to assess the occurrence of adverse events and to identify factors that may affect the safety of the vaccine under real-life, post-marketing conditions. No hypothesis testing was conducted in this survey.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must be vaccinated with VARIVAX as a standard of care

Exclusion criteria

  • Participants who have been previously vaccinated with VARIVAX
  • Contraindication with VARIVAX

Treatment and study plan

VARIVAX™

Biological

Attenuated live varicella vaccine

Primary outcomes

  1. Percentage of Participants With One or More Adverse Events (AEs)

    Time frame: Up to 42 days after vaccination

    An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.

    Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.

  2. Percentage of Participants With One or More AEs by Gender

    Time frame: Up to 42 days after vaccination

    An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.

    Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.

  3. Percentage of Participants With One or More AEs by Age

    Time frame: Up to 42 days after vaccination

    An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.

    Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.

  4. Percentage of Participants With One or More Adverse Drug Reactions (ADRs)

    Time frame: Up to 42 days after vaccination

    An ADR is an AE (defined above) for which relatedness to the use of the product cannot be ruled out

  5. Percentage of Participants With One or More Unexpected AEs

    Time frame: Up to 42 days after vaccination

    Unexpected AEs differed from AEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome

  6. Percentage of Participants With One or More Unexpected ADRs

    Time frame: Up to 42 days after vaccination

    An unexpected ADR is an unexpected AE (defined above) for which relatedness to the use of the study vaccine cannot be ruled out

  7. Percentage of Participants With One or More Serious Adverse Events (SAEs)

    Time frame: Up to 42 days after vaccination

    An SAE is any AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event based on appropriate medical judgment.

  8. Percentage of Participants With One or More Serious ADRs

    Time frame: Up to 42 days after vaccination

    A serious ADR is an SAE (defined above) for which relatedness to the use of the product cannot be ruled out

  9. Percentage of Participants With One or More Unexpected SAEs

    Time frame: Up to 42 days after vaccination

    Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Re-examination Study for General Vaccine Use to Assess the Safety Profile of Varivax in Usual Practice

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 4, 2010
Registry last updated
Sep 4, 2015

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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