Varicella
Conditions
Keywords
Varicella
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.
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.
Interventions
BIOLOGICALVARIVAX™
Attenuated live varicella vaccine
Sponsors
Merck Sharp & Dohme LLC
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With One or More Adverse Events (AEs) | 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 | 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 | 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) | 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 | 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 | 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) | 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 | 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 | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 727 |
| Total | 727 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Enrolled more than once | 2 |
| Overall Study | Failed to meet inclusion criteria | 2 |
| Overall Study | Investigated before study start | 13 |
| Overall Study | Outside chief indications | 10 |
Baseline characteristics
| Characteristic | VARIVAX |
|---|---|
| Age, Continuous | 1.19 years STANDARD_DEVIATION 0.92 |
| Age, Customized <2 years | 686 Participants |
| Age, Customized ≥2 years | 41 Participants |
| Sex: Female, Male Female | 347 Participants |
| Sex: Female, Male Male | 380 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 105 / 727 |
| serious Total, serious adverse events | 4 / 727 |
Outcome results
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
Time frame: Up to 42 days after vaccination
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VARIVAX | Percentage of Participants With One or More Adverse Drug Reactions (ADRs) | 3.30 percentage of participants |
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.
Time frame: Up to 42 days after vaccination
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VARIVAX | Percentage of Participants With One or More Adverse Events (AEs) | 37.69 Percentage of Participants |
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.
Time frame: Up to 42 days after vaccination
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VARIVAX | Percentage of Participants With One or More AEs by Age | 36.01 percentage of participants |
| Female Participants | Percentage of Participants With One or More AEs by Age | 65.85 percentage of participants |
p-value: 0.0001Chi-squared
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.
Time frame: Up to 42 days after vaccination
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VARIVAX | Percentage of Participants With One or More AEs by Gender | 37.63 percentage of participants |
| Female Participants | Percentage of Participants With One or More AEs by Gender | 37.75 percentage of participants |
p-value: 0.9733Chi-squared
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
Time frame: Up to 42 days after vaccination
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VARIVAX | Percentage of Participants With One or More Serious ADRs | 0 percentage of participants |
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.
Time frame: Up to 42 days after vaccination
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VARIVAX | Percentage of Participants With One or More Serious Adverse Events (SAEs) | 0.55 percentage of participants |
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
Time frame: Up to 42 days after vaccination
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VARIVAX | Percentage of Participants With One or More Unexpected ADRs | 0.14 percentage of participants |
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
Time frame: Up to 42 days after vaccination
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VARIVAX | Percentage of Participants With One or More Unexpected AEs | 26.00 percentage of participants |
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
Time frame: Up to 42 days after vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VARIVAX | Percentage of Participants With One or More Unexpected SAEs | 0.28 percentage of participants |