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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01062061
First received: February 2, 2010
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Varicella
Biological: VARIVAX™

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Re-examination Study for General Vaccine Use to Assess the Safety Profile of Varivax in Usual Practice

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants With One or More Adverse Events (AEs) [ Time Frame: Up to 42 days after vaccination ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Up to 42 days after vaccination ] [ Designated as safety issue: Yes ]

    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 Age [ Time Frame: Up to 42 days after vaccination ] [ Designated as safety issue: Yes ]

    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 Adverse Drug Reactions (ADRs) [ Time Frame: Up to 42 days after vaccination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 42 days after vaccination ] [ Designated as safety issue: Yes ]
    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 Unexpected ADRs [ Time Frame: Up to 42 days after vaccination ] [ Designated as safety issue: Yes ]
    An unexpected ADR is an unexpected AE (defined above) for which relatedness to the use of the study vaccine cannot be ruled out

  • Percentage of Participants With One or More Serious Adverse Events (SAEs) [ Time Frame: Up to 42 days after vaccination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 42 days after vaccination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 42 days after vaccination ] [ Designated as safety issue: Yes ]
    Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome


Enrollment: 754
Study Start Date: June 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Biological: VARIVAX™
Attenuated live varicella vaccine

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.

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Korean participants being vaccinated with VARIVAX in usual practice

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062061

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01062061     History of Changes
Other Study ID Numbers: V210-059, 2010_004
Study First Received: February 2, 2010
Results First Received: April 16, 2013
Last Updated: September 3, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Varicella

ClinicalTrials.gov processed this record on September 18, 2014