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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004039-21 | EudraCT Number |
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GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.
The protocol was amended to reflect a change in the prescribing information. The age of the infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first vaccination. This protocol posting has been amended in order to comply with FDA AA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort Group | Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarix | Biological | Two doses of the oral vaccine |
| |
| Data collection |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea). | Grade 2 or 3 symptoms assessed include fever, vomiting and diarrhea. Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C or rectal temperature above 38.5°C and below or equal to 39.5°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhea was defined as at least 6 looser than normal stools per day. | During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited symptoms assessed included cough, diarrhea, fever, irritability, loss of appetite and vomiting. Any = Any reports of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 3 symptom: symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all, grade 3 fever = axillary temperature > 39.0°C, grade 3 vomiting = ≥ 3 episodes of vomiting/day and grade 3 diarrhea = ≥ 6 looser than normal stools/day. Related = symptom assessed by the investigator as causally related to the vaccination regardless of intensity grade. |
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Inclusion Criteria:
Exclusion Criteria:
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Filipino subjects aged at least 6 weeks at the time of first vaccination
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Alabang, Muntinlupa City | 1780 | Philippines | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25424932 | Background | Bravo L, Chitraka A, Liu A, Choudhury J, Kumar K, Berezo L, Cimafranca L, Chatterjee P, Garg P, Siriwardene P, Bernardo R, Mehta S, Balasubramanian S, Karkada N, Htay Han H. Reactogenicity and safety of the human rotavirus vaccine, Rotarix in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother. 2014;10(8):2276-83. doi: 10.4161/hv.29280. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotarix Group | Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Other |
Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning. |
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| During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2). |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose. |
| Number of Subjects Reporting Serious Adverse Events (SAE) | Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | Throughout the study period (Day 0 to one month post-Dose 2). |
| Binangonan, Rizal |
| Philippines |
| GSK Investigational Site | Cainta, Rizal | Philippines |
| GSK Investigational Site | City of Muntinlupa | 1780 | Philippines |
| GSK Investigational Site | Gen. Trias, Cavite | Philippines |
| GSK Investigational Site | Imus, Cavite | Philippines |
| GSK Investigational Site | Los Banos, Laguna | 4027 | Philippines |
| GSK Investigational Site | Makati City | Philippines |
| GSK Investigational Site | Manila | 1000 | Philippines |
| GSK Investigational Site | Manila | Philippines |
| GSK Investigational Site | Maybunga, Pasig City | Philippines |
| GSK Investigational Site | Pasay | Philippines |
| GSK Investigational Site | Pasig City, Metro Manila | 1600 | Philippines |
| GSK Investigational Site | Quezon City | 1102 | Philippines |
| GSK Investigational Site | Quezon City | 1113 | Philippines |
| GSK Investigational Site | Quezon City | Philippines |
| GSK Investigational Site | Talaba IV, Bacoor, Cavite | Philippines |
| GSK Investigational Site | Taytay, Rizal | Philippines |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotarix Group | Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea). | Grade 2 or 3 symptoms assessed include fever, vomiting and diarrhea. Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C or rectal temperature above 38.5°C and below or equal to 39.5°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhea was defined as at least 6 looser than normal stools per day. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented. | Posted | Number | Subjects | During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2). |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited symptoms assessed included cough, diarrhea, fever, irritability, loss of appetite and vomiting. Any = Any reports of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 3 symptom: symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all, grade 3 fever = axillary temperature > 39.0°C, grade 3 vomiting = ≥ 3 episodes of vomiting/day and grade 3 diarrhea = ≥ 6 looser than normal stools/day. Related = symptom assessed by the investigator as causally related to the vaccination regardless of intensity grade. | The analysis was performed on the Total Vaccinated cohort , which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented. | Posted | Number | Subjects | During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2). |
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AE) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented. | Posted | Number | Subjects | During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose. |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAE) | Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented. | Posted | Number | Participants | Throughout the study period (Day 0 to one month post-Dose 2). |
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Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
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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 | Rotarix Group | Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks. | 0 | 1,439 | 33 | 1,439 | 827 | 1,439 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Amoebic dysentery | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Amoebiasis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Diarrhoea infections | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Exanthema subitum | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Hypersomnia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Hypophagia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Intussusception | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Milk anyergy | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Roseola | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Urinary tract infection enterococcal | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Viral rash | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Fever | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Loss of appetite | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Vomiting | General disorders | MedDRA 15.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C492457 | RIX4414 vaccine |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Grade 2/3; Across Doses |
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