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This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotarix Group | Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarixâ„¢ | Biological | Two oral doses, with at least 4 weeks interval in-between |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea | Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius. Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day. | During the 8-day solicited follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Each Type of Solicited General Symptoms | Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting. | During the 8-day follow-up period |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Colombo | 03 | Sri Lanka |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Ruberu D et al. Post-marketing surveillance of a live-attenuated human rotavirus vaccine (Rotarixâ„¢) in India and Sri Lanka. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand, 18-20 October 2011. | ||
| 25424932 | Derived | 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 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotarix Group | Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 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 With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea | Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius. Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day. | Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented. | Posted | Number | subjects | During the 8-day solicited follow-up 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 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crying | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C492457 | RIX4414 vaccine |
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Unsolicited AEs cover 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 |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject | Throughout the study period (Day 0 to Month 3 or 4) |
| Lost to Follow-up |
|
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Subjects Reporting Each Type of Solicited General Symptoms | Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting. | Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented. | Posted | Number | subjects | During the 8-day follow-up period |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Unsolicited AEs cover 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 consisted of all vaccinated subjects with at least one vaccine administration documented. | Posted | Number | subjects | During the 31-day follow-up period |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject | Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented. | Posted | Number | subjects | Throughout the study period (Day 0 to Month 3 or 4) |
|
|
|
| 1 |
| 522 |
| 247 |
| 522 |
| Diarrhoea | General disorders | Systematic Assessment |
|
| Loss of appetite | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Vomiting | General disorders | 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 |
| Title | Measurements |
|---|
|
| Loss of appetite |
|
| Fever |
|
| Vomiting |
|