Infections, Rotavirus
Conditions
Keywords
Gastroenteritis
Brief summary
This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves male or female infants from the age of 6 weeks at the time of the first vaccination. The vaccination course must be completed by the age of 24 weeks.
Detailed description
The protocol posting has been amended to reflect the two new vaccine presentations that have been launched in Korea. The current PMS will thus collect safety information from subjects who have received either Rotarix or Rotarix liquid formulation (oral suspension or prefilled syringe) in the course of their routine clinical practice according to the prescribing information in Korea.
Interventions
BIOLOGICALRotarix or Rotarix liquid formulation
GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine (oral suspension or prefilled syringe).
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 24 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Infants who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the PMS. * A male or female infant from the age of 6 weeks at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the infant.
Exclusion criteria
• At the time of PMS entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited General Symptoms | During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period | Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period | During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period | During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period | During the 31 day follow-up period after each vaccine dose for Year 5 study period | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period | During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 & Year 2 Study Period | During the post-marketing study period for Year 1 & Year 2 study period | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period | During the post-marketing study period for Year 3 & Year 4 study period | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period | During the post-marketing study period for Year 5 study period | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period | During the post-marketing study period for Year 1 to Year 6 study period | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. |
Countries
South Korea
Participant flow
Recruitment details
This post marketing study (PMS) covered a period of 6 consecutive years. Results were presented for Years 1, 2, 3, 4, 5 (Year \[Y\] 1 & Y2 data combined and presented at the Y2 time point and Y3 & Y4 data combined and presented at the Y4 time point) along with consolidated surveillance data from Y1- Y6 timepoint.
Pre-assignment details
Consolidated participant flow and baseline measure data were given for Years 1 to 6 time point in order to account for all the subjects participating in this study.
Participants by arm
| Arm | Count |
|---|---|
| Rotarix Group Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. | 3,111 |
| Total | 3,111 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Lost to Follow-up | 510 |
| Overall Study | Other | 17 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Rotarix Group |
|---|---|
| Age, Continuous | 9.6 weeks STANDARD_DEVIATION 2.22 |
| Race/Ethnicity, Customized Chinese | 2 Participants |
| Race/Ethnicity, Customized Japanese | 2 Participants |
| Race/Ethnicity, Customized Korean | 3107 Participants |
| Sex: Female, Male Female | 1525 Participants |
| Sex: Female, Male Male | 1586 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3,111 |
| other Total, other adverse events | 684 / 3,111 |
| serious Total, serious adverse events | 26 / 3,111 |
Outcome results
Primary
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the post-marketing study period for Year 1 to Year 6 study period
Population: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available for Year 1 to Year 6 study period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period | 26 Participants |
Primary
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 & Year 2 Study Period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the post-marketing study period for Year 1 & Year 2 study period
Population: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented for whom data were available at Year 1 and Year 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 & Year 2 Study Period | 6 Participants |
Primary
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the post-marketing study period for Year 3 & Year 4 study period
Population: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented for whom data were available at Year 3 and Year 4.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period | 13 Participants |
Primary
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the post-marketing study period for Year 5 study period
Population: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented for whom data were available at Year 5.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period | 4 Participants |
Primary
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.
Time frame: During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period
Population: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 1 and Year 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Cough | 204 Participants |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Diarrhoea | 50 Participants |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Irritability | 405 Participants |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Loss of appetite | 259 Participants |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Temperature | 135 Participants |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Vomiting | 200 Participants |
Primary
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period
Population: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available for the Year 1 to Year 6 study period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period | 1201 Participants |
Primary
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period
Population: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 1 and Year 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period | 334 Participants |
Primary
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period
Population: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 3 and Year 4.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period | 413 Participants |
Primary
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 31 day follow-up period after each vaccine dose for Year 5 study period
Population: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 5.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period | 254 Participants |