VaricellaNCT01062061
Re-examination Study For Varivax (V210-059 AM2)
An observational study of Varicella, run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- VARIVAX™
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 754 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to May 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Korean participants being vaccinated with VARIVAX in usual practice
Who may be able to join
- Participants must be vaccinated with VARIVAX as a standard of care
Who cannot join
- Participants who have been previously vaccinated with VARIVAX
- Contraindication with VARIVAX
About this study
Official title: Re-examination Study for General Vaccine Use to Assess the Safety Profile of Varivax in Usual Practice
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.
Read the 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.
- Conditions
- Varicella
- Being tested
- VARIVAX™
- Keywords
- Varicella
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VARIVAX™Biological
Attenuated live varicella vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: VARIVAX™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to 42 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJun 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VaricellaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062061
- Sponsor's protocol ID
- V210-059
- Other IDs
- 2010_004
- Status last verified
- Sep 2015
- First submitted
- 2 Feb 2010
- Last updated
- 4 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-examination Study for General Vaccine Use to Assess the Safety Profile of Varivax in Usual Practice
- ClinicalTrials.gov ID
- NCT01062061
- Acronym / sponsor ID
- V210-059
- Conditions
- Varicella
- Keywords
- Varicella
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 754 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Posted 3 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VARIVAX | – | Biological: 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. |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Korean participants being vaccinated with VARIVAX in usual practice
Key inclusion criteria (1 listed)
- Participants must be vaccinated with VARIVAX as a standard of care
Key exclusion criteria (2 listed)
- Participants who have been previously vaccinated with VARIVAX
- Contraindication with VARIVAX
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VARIVAX™Attenuated live varicella vaccine | Biological | VARIVAX |
Primary outcome
Percentage of Participants With One or More Adverse Events (AEs)
Time frame: Up to 42 days after vaccination
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
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
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
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
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
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
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
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
Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Varicella, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With One or More Adverse Events (AEs) (time frame: Up to 42 days after vaccination). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.