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

Varicella Clinical Trial

Official title:

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

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

• Varicella

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