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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_004 | Other Identifier | Merck |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VARIVAXâ„¢ | Biological | Attenuated live varicella vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Korean participants being vaccinated with VARIVAX in usual practice
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow | Posted | Number | Percentage of Participants | Up to 42 days after vaccination |
|
Up to 42 days after vaccination
Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (15.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (15.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| 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 |
| Failed to meet inclusion criteria |
|
| years |
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| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | 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. |
|
|
| Primary | 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. | AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow | Posted | Number | percentage of participants | Up to 42 days after vaccination |
|
|
|
|
| Primary | 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. | AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow | Posted | Number | percentage of participants | Up to 42 days after vaccination |
|
|
|
|
| Primary | 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 | ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow | Posted | Number | percentage of participants | Up to 42 days after vaccination |
|
|
|
| Primary | 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 | Unexpected AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow | Posted | Number | percentage of participants | Up to 42 days after vaccination |
|
|
|
| Primary | 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 | Unexpected ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow | Posted | Number | percentage of participants | Up to 42 days after vaccination |
|
|
|
| Primary | 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. | SAEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow | Posted | Number | percentage of participants | Up to 42 days after vaccination |
|
|
|
| Primary | 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 | Serious ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow | Posted | Number | percentage of participants | Up to 42 days after vaccination |
|
|
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| Primary | 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 | Posted | Number | percentage of participants | Up to 42 days after vaccination |
|
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|
| 4 |
| 727 |
| 105 |
| 727 |
| Bronchitis | Infections and infestations | MedDRA (15.0) |
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| Pneumonia | Infections and infestations | MedDRA (15.0) |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) |
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| Oliguria | Renal and urinary disorders | MedDRA (15.0) |
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| Bronchitis | Infections and infestations | MedDRA (15.0) |
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| D007239 | Infections |
| D045424 |
| Complex Mixtures |