An observational study in Varicella, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 12 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-04.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Observational
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.
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.
156 studies on the registry are indexed under Chickenpox; 26 are open to participants now.
This study's enrollment of 754 is above the median of 400 across 19 observational studies indexed under Chickenpox.
Browse Chickenpox studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Korean participants being vaccinated with VARIVAX in usual practice
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Exclusion Criteria:
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Up to 42 days after vaccination
| Milestone | VARIVAX |
|---|---|
| Started | 754 |
| Completed | 727 |
| Not completed | 27 |
| Withdrew: Enrolled more than once | 2 |
| Withdrew: Investigated before study start | 13 |
| Withdrew: Outside chief indications | 10 |
| Withdrew: Failed to meet inclusion criteria | 2 |
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 | VARIVAX |
|---|---|
| Percentage of Participants With One or More Adverse Events (AEs) | 37.69 |
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 | Male Participants | Female Participants |
|---|---|---|
| Percentage of Participants With One or More AEs by Gender | 37.63 | 37.75 |
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 | Age <2 Years | Age ≥2 Years |
|---|---|---|
| Percentage of Participants With One or More AEs by Age | 36.01 | 65.85 |
An ADR is an AE (defined above) for which relatedness to the use of the product cannot be ruled out
| percentage of participants | VARIVAX |
|---|---|
| Percentage of Participants With One or More Adverse Drug Reactions (ADRs) | 3.30 |
Unexpected AEs differed from AEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome
| percentage of participants | VARIVAX |
|---|---|
| Percentage of Participants With One or More Unexpected AEs | 26.00 |
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 | VARIVAX |
|---|---|
| Percentage of Participants With One or More Unexpected ADRs | 0.14 |
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 | VARIVAX |
|---|---|
| Percentage of Participants With One or More Serious Adverse Events (SAEs) | 0.55 |
A serious ADR is an SAE (defined above) for which relatedness to the use of the product cannot be ruled out
| percentage of participants | VARIVAX |
|---|---|
| Percentage of Participants With One or More Serious ADRs | 0 |
Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome
| percentage of participants | VARIVAX |
|---|---|
| Percentage of Participants With One or More Unexpected SAEs | 0.28 |
Collected over Up to 42 days after vaccination. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VARIVAX | — | 4/727 (0.6%) | 105/727 (14.4%) |
| Event | VARIVAX |
|---|---|
| PyrexiaGeneral disorders | 1/727 |
| BronchitisInfections and infestations | 1/727 |
| PneumoniaInfections and infestations | 1/727 |
| Decreased appetiteMetabolism and nutrition disorders | 1/727 |
| OliguriaRenal and urinary disorders | 1/727 |
| Event | VARIVAX |
|---|---|
| BronchitisInfections and infestations | 58/727 |
| PyrexiaGeneral disorders | 51/727 |
| Age, Continuous(years) | VARIVAX |
|---|---|
| Mean | 1.19 ± 0.92 |
| Age, Customized(Participants) | VARIVAX |
|---|---|
| <2 years | 686 |
| ≥2 years | 41 |
| Sex: Female, Male(Participants) | VARIVAX |
|---|---|
| Female | 347 |
| Male | 380 |
No study locations are listed for this record.
The record gives a start of Jun 2007, a primary completion of May 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2013, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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