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This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotarix Group | Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarixâ„¢ at an interval of not less than 4 weeks between the doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarixâ„¢ | Biological | Two doses of oral vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea) | Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°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 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day. | During the 8-day (Day 0 - Day 7) follow-up period after each vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited General Symptoms | Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day |
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Inclusion Criteria:
Exclusion Criteria:
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subjects from the age of 6 weeks at the time of the first Rotarixâ„¢ vaccination and less than 24 weeks of age at the time of second Rotarixâ„¢ vaccination
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bangalore | 560 011 | India | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Kumar k et al. Safety and reactogenicity of RIX4414 live attenuated human rotavirus vaccine: An Indian post-marketing surveillance study. Abstract presented at the 48th National Conference of Indian Academy of Pediatrics (Pedicon). Jaipur, India, 19-23 January 2011. | ||
| 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 who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarixâ„¢ at an interval of not less than 4 weeks between the doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotarix Group | Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarixâ„¢ at an interval of not less than 4 weeks between the doses. |
| 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 Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea) | Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°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 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day. | Analysis was performed on the Total Vaccinated Cohort. | Posted | Number | subjects | During the 8-day (Day 0 - Day 7) follow-up period after each vaccination. |
|
Serious adverse events: throughout the study period (Day 0-Day 30). Other adverse events: during the 8-day (Day 0-Day 7) follow-up period after each vaccination.
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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 who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarixâ„¢ at an interval of not less than 4 weeks between the doses. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | 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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| During the 8-day (Day 0 - Day 7) follow-up period after each vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 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 (Day 0 - Day 30) follow-up period after each vaccination |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are 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 (from Day 0 up to Day 30) |
| Bangalore |
| 560 095 |
| India |
| GSK Investigational Site | Chennai | 600 033 | India |
| GSK Investigational Site | Delhi | 110085 | India |
| GSK Investigational Site | Delhi | 110088 | India |
| GSK Investigational Site | Kolkata | 700064 | India |
| GSK Investigational Site | Kolkata | India |
| GSK Investigational Site | Mumbai | 400 053 | India |
| GSK Investigational Site | Mumbai | 400081 | India |
| GSK Investigational Site | Mumbai | India |
| GSK Investigational Site | New Delhi | 110087 | India |
| GSK Investigational Site | Pune | 411044 | India |
| Lost to Follow-up |
|
| 2nd dose received outside of the study |
|
| Vaccine not received as out of stock |
|
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Subjects Reporting Solicited General Symptoms | Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day | Analysis was performed on the Total Vaccinated Cohort. | Posted | Number | subjects | During the 8-day (Day 0 - Day 7) follow-up period after each vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 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. | Posted | Number | subjects | During the 31-day (Day 0 - Day 30) follow-up period after each vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are 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. | Posted | Number | subjects | Throughout the study period (from Day 0 up to Day 30) |
|
|
|
| 0 |
| 332 |
| 0 |
| 332 |
| 133 |
| 332 |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Decreased activity | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tongue discolouration | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | 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 |
|
| Temperature (axillary) |
|
| Vomiting |
|