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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01062061
Other study ID # V210-059
Secondary ID 2010_004
Status Completed
Phase N/A
First received February 2, 2010
Last updated September 3, 2015
Start date June 2007
Est. completion date May 2012

Study information

Verified date September 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 754
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months and older
Eligibility 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

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Biological:
VARIVAX™
Attenuated live varicella vaccine

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Primary 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 Yes
Primary 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 Yes
Primary 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 Yes
Primary 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 Yes
Primary 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 Yes
Primary 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 Yes
Primary 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 Yes
Primary 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 Yes
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