Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarix or Rotarix liquid formulation | Biological | GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine (oral suspension or prefilled syringe). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting. | During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period |
| 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. | During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period |
| 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. | During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period |
| 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. | During the 31 day follow-up period after each vaccine dose for Year 5 study period |
| 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 |
Not provided
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Infants aged at least 6 weeks will be administered two doses of Rotarix or Rotarix liquid formulation (oral suspension or prefilled syringe) orally as per the prescribing information in Korea.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Seoul | 122-896 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27494163 | Derived | Shin SM, Kim CS, Karkada N, Liu A, Jayadeva G, Han HH. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix). Hum Vaccin Immunother. 2016 Oct 2;12(10):2590-2594. doi: 10.1080/21645515.2016.1189046. Epub 2016 Aug 5. |
| Label | URL |
|---|---|
| Full CSR posting. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting. | 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. | Posted | Count of Participants | Participants | During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period |
|
Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively.
Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus paralytic | Gastrointestinal disorders | MedDRA | Systematic Assessment | "Gastro-intestinal system disorders" SOC as per WHO-ART dictionary. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
Not provided
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C492457 | RIX4414 vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period |
| 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. | During the post-marketing study period for Year 1 & Year 2 study period |
| 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. | During the post-marketing study period for Year 3 & Year 4 study period |
| 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. | During the post-marketing study period for Year 5 study period |
| 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. | During the post-marketing study period for Year 1 to Year 6 study period |
| Other |
|
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | During the 31 day follow-up period after each vaccine dose for Year 5 study period |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | During the post-marketing study period for Year 1 & Year 2 study period |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | During the post-marketing study period for Year 3 & Year 4 study period |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | During the post-marketing study period for Year 5 study period |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | During the post-marketing study period for Year 1 to Year 6 study period |
|
|
|
| 0 |
| 3,111 |
| 26 |
| 3,111 |
| 684 |
| 3,111 |
|
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment | "Gastro-intestinal system disorders" SOC as per WHO-ART dictionary. |
|
| Otitis Media | Ear and labyrinth disorders | MedDRA | Systematic Assessment | "Resistance mechanism disorders" SOC as per WHO-ART dictionary. |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment | "Resistance mechanism disorders" SOC as per WHO-ART dictionary. |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA | Systematic Assessment | "Gastro-intestinal system disorders" SOC as per WHO-ART dictionary. |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | "Respiratory system disorders" SOC as per WHO-ART dictionary. |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment | "Urinary System Disorders" SOC as per WHO-ART dictionary. |
|
| Bronchopneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | "Respiratory system disorders" SOC as per WHO-ART dictionary. |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | "Respiratory system disorders" SOC as per WHO-ART dictionary. |
|
| Bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | "Respiratory system disorders" SOC as per WHO-ART dictionary. |
|
| Croup | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | "Respiratory system disorders" SOC as per WHO-ART dictionary. |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | "Respiratory system disorders" SOC as per WHO-ART dictionary. |
|
| Gastroenteritis viral | Gastrointestinal disorders | MedDRA | Systematic Assessment | "Gastro-intestinal system disorders" SOC as per WHO-ART dictionary. |
|
| Pneumonia viral | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | "Respiratory system disorders" SOC as per WHO-ART dictionary. |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA | Systematic Assessment | "Urinary System Disorders" SOC as per WHO-ART dictionary. |
|
| Fever | General disorders | MedDRA | Systematic Assessment | "Body as a whole - general disorders" SOC as per WHO-ART dictionary. |
|
| Cytomegalovirus Gastrointestinal Infection | Gastrointestinal disorders | MedDRA; WHO-ART | Systematic Assessment | "Secondary items - events" SOC as per WHO-ART dictionary. |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Irritability | General disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |