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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_012 | Other Identifier | Merck |
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This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Rotateq through collecting the safety information according to the Re-examination Regulation for New Drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotateq | Korean Infants vaccinated with Rotateq in usual practice. The Rotateq vaccination series consists of 3 ready-to-use liquid (oral) doses with the first dose to be administered at age 6-12 weeks and subsequent doses to be administered at 4 to 10-week intervals. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Any Adverse Experience | An adverse experience 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 of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. | Up to 42 days after any Rotateq vaccination |
| Percentage of Participants With Any Adverse Drug Reaction | An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out | Up to 42 days after any Rotateq vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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6-32 week old Korean Infants who are vaccinated with Rotateq in usual practice
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotateq | Korean infants vaccinated with Rotateq in usual practice |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline characteristics were reported for all enrolled participants who received at least 1 dose of study vaccine
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotateq | Korean infants vaccinated with Rotateq in usual practice |
| 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 Any Adverse Experience | An adverse experience 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 of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. | All enrolled participants who received at least 1 dose of study vaccine were included in the analysis | Posted | Number | Percent of participants | Up to 42 days after any Rotateq vaccination |
|
Up to 42 days after any Rotateq vaccination
All enrolled participants who received at least 1 dose of study vaccine were included in the analysis
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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 | Rotateq | Korean infants vaccinated with Rotateq in usual practice |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 16.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 |
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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 |
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| Violation of vaccine dose or dosage |
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| Duplicate Case Report Form |
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| Weeks |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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|
| Primary | Percentage of Participants With Any Adverse Drug Reaction | An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out | All enrolled participants who received at least 1 dose of study vaccine were included in the analysis | Posted | Number | Percent of participants | Up to 42 days after any Rotateq vaccination |
|
|
|
| 8 |
| 3,395 |
| 210 |
| 3,395 |
| Laryngitis | Infections and infestations | MedDRA 16.0 |
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| Pneumonia | Infections and infestations | MedDRA 16.0 |
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| Urinary tract infection | Infections and infestations | MedDRA 16.0 |
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| Enteritis | Gastrointestinal disorders | MedDRA 16.0 |
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| Pyrexia | General disorders | MedDRA 16.0 |
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In regard to surveillance results, any publication should be agreed by the sponsor in advance