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

NCT01062061 | Completed Results

• 2 other identifiers: V210-0592010_004
• Study Type: observational
• Target: 754
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Varicella

Keywords

Varicella

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

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™

Interventions

VARIVAX™ BIOLOGICAL

Attenuated live varicella vaccine

VARIVAX

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Korean participants being vaccinated with VARIVAX in usual practice

You may qualify if:

• Participants must be vaccinated with VARIVAX as a standard of care

You may not qualify if:

• Participants who have been previously vaccinated with VARIVAX
• Contraindication with VARIVAX

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Chickenpox

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 4, 2010
• Study Start: June 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 4, 2015
• Results First Posted: July 3, 2013

Record last verified: 2015-09