Re-examination Study For Varivax (V210-059 AM2)
- Conditions
- Varicella
- Interventions
- Biological: VARIVAX™
- Registration Number
- NCT01062061
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 754
- Participants must be vaccinated with VARIVAX as a standard of care
- Participants who have been previously vaccinated with VARIVAX
- Contraindication with VARIVAX
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description VARIVAX VARIVAX™ 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With One or More Adverse Drug Reactions (ADRs) 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
Percentage of Participants With One or More Unexpected AEs 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
Percentage of Participants With One or More AEs by Age 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.Percentage of Participants With One or More Serious Adverse Events (SAEs) 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.
Percentage of Participants With One or More Serious ADRs 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
Percentage of Participants With One or More Unexpected SAEs 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
Percentage of Participants With One or More Adverse Events (AEs) 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.Percentage of Participants With One or More AEs by Gender 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.Percentage of Participants With One or More Unexpected ADRs 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
- Secondary Outcome Measures
Name Time Method