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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Varicella

Intervention / Treatment
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* Biological: VARIVAX™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VARIVAX<br>Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age. | Biological: VARIVAX™<br>* Attenuated live varicella vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With One or More Adverse Events (AEs) | 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. | Up to 42 days after vaccination | 
| Percentage of Participants With One or More AEs by Gender | 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. | Up to 42 days after vaccination | 
| Percentage of Participants With One or More AEs by Age | 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. | Up to 42 days after vaccination | 
| Percentage of Participants With One or More Adverse Drug Reactions (ADRs) | An ADR is an AE (defined above) for which relatedness to the use of the product cannot be ruled out | Up to 42 days after vaccination | 
| Percentage of Participants With One or More Unexpected AEs | Unexpected AEs differed from AEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome | Up to 42 days after vaccination | 
| Percentage of Participants With One or More Unexpected ADRs | An unexpected ADR is an unexpected AE (defined above) for which relatedness to the use of the study vaccine cannot be ruled out | Up to 42 days after vaccination | 
| Percentage of Participants With One or More Serious Adverse Events (SAEs) | 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. | Up to 42 days after vaccination | 
| Percentage of Participants With One or More Serious ADRs | A serious ADR is an SAE (defined above) for which relatedness to the use of the product cannot be ruled out | Up to 42 days after vaccination | 
| Percentage of Participants With One or More Unexpected SAEs | Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome | Up to 42 days after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicella