MedDataX Logo

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

NCT ID: NCT01062061

Last Updated: 2015-09-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

754 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

GARDASIL Reexamination Study (V501-059)

NCT01062074

Human Papillomavirus (HPV) Infection
COMPLETED

A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)

NCT01077804

Varicella Herpes Zoster
COMPLETED

Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children (V210-056)

NCT00496327

Varicella
COMPLETED PHASE3

Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)

NCT02062502

Varicella
COMPLETED PHASE3

A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)

NCT01626794

Varicella
WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Varicella

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

VARIVAX™

Intervention Type BIOLOGICAL

Attenuated live varicella vaccine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VARIVAX™

Attenuated live varicella vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010_004

Identifier Type: OTHER

Identifier Source: secondary_id

V210-059

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058)
NCT03843632 COMPLETED PHASE3
A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age.
NCT02570126 COMPLETED PHASE3
Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)
NCT00822237 COMPLETED PHASE3
A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age
NCT06693895 RECRUITING PHASE3
An Immunity Persistence Study of Live Attenuated Varicella Vaccine
NCT05095701 ENROLLING_BY_INVITATION PHASE4
Study of Two Formulations of GSK Biologicals' Varicella Vaccine
NCT00568334 COMPLETED PHASE2
Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
NCT03239873 COMPLETED PHASE3
A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age
NCT05084508 COMPLETED PHASE2
The Safety, Immunogenicity and Immune Effect Research of the Varicella Vaccine After the 2nd Dose Vaccination
NCT01830283 UNKNOWN PHASE4
Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females
NCT01101542 COMPLETED
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
NCT06740630 RECRUITING PHASE3
Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
NCT00792623 COMPLETED PHASE2
A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age
NCT06806137 RECRUITING PHASE3
A Lot-to-Lot Consistency Study to Evaluate Safety, Tolerability, and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Healthy Adults (V212-014)
NCT02180295 WITHDRAWN PHASE3
Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine
NCT01817270 COMPLETED PHASE4
Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)
NCT00681031 COMPLETED PHASE4
An Open-labelled Clinical Trial of Live Attenuated Varicella Vaccines to Evaluate the Immunity Persistence After Primary Immunization and Safety and Immunogenicity After the Booster Immunization
NCT05150392 COMPLETED PHASE3
A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children
NCT02965404 COMPLETED PHASE1
A Phase 3 Lot-consistency Clinical Trial of Live Attenuated Varicella Vaccine
NCT03555071 COMPLETED PHASE3
Correlation of Protection Against Varicella in an Exploratory Study
NCT06482216 NOT_YET_RECRUITING
Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox
NCT00226499 COMPLETED PHASE3
Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
NCT05015686 ENROLLING_BY_INVITATION PHASE3
The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
NCT01866566 UNKNOWN PHASE4
ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)
NCT01556451 COMPLETED PHASE4
Immunogenicity, Safety and Protective Effect of Live Attenuated Varicella Vaccine and Study on Antibody Level and Etiology of Varicella Zoster Virus
NCT05460429 UNKNOWN PHASE4