Gastroenteritis Rotavirus
Conditions
Keywords
Gastroenteritis rotavirus
Brief summary
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 32 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Infants Who Are Vaccinated With Rotateq For The Prevention Of Rotavirus Gastroenteritis Within Local Labeling Will Be Included
Exclusion criteria
* Participants who are vaccinated with Rotateq before study start * Participant who has a contraindication to Rotateq according to the local label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Any Adverse Experience | Up to 42 days after any Rotateq vaccination | 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. |
| Percentage of Participants With Any Adverse Drug Reaction | Up to 42 days after any Rotateq vaccination | An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rotateq Korean infants vaccinated with Rotateq in usual practice | 3,395 |
| Total | 3,395 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case report before date of contract | 40 |
| Overall Study | Case report unclear | 6 |
| Overall Study | Duplicate Case Report Form | 5 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Violation of vaccine dose or dosage | 351 |
Baseline characteristics
| Characteristic | Rotateq |
|---|---|
| Age, Continuous | 9.57 Weeks STANDARD_DEVIATION 1.03 |
| Age, Customized >10 weeks | 565 Participants |
| Age, Customized <8 weeks | 90 Participants |
| Age, Customized Between 8 and 10 weeks | 2740 Participants |
| Sex: Female, Male Female | 1692 Participants |
| Sex: Female, Male Male | 1703 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 210 / 3,395 |
| serious Total, serious adverse events | 8 / 3,395 |
Outcome results
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
Time frame: Up to 42 days after any Rotateq vaccination
Population: All enrolled participants who received at least 1 dose of study vaccine were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotateq | Percentage of Participants With Any Adverse Drug Reaction | 4.27 Percent of participants |
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.
Time frame: Up to 42 days after any Rotateq vaccination
Population: All enrolled participants who received at least 1 dose of study vaccine were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotateq | Percentage of Participants With Any Adverse Experience | 22.12 Percent of participants |