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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001543-36 | EudraCT Number |
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This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (HBV) vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotarix Group | Experimental | Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule. |
|
| Placebo Group | Placebo Comparator | Subjects received 2 oral doses of placebo according to a 0, 1 month schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarix | Biological | Two-dose oral vaccination. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains | Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. | From 2 weeks after Dose 2 up to 2 years of age |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains | A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system). | From 2 weeks after Dose 2 up to 2 years of age |
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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 | Aichi | 451-0052 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21640780 | Background | Kawamura N, Tokoeda Y, Oshima M, Okahata H, Tsutsumi H, Van Doorn LJ, Muto H, Smolenov I, Suryakiran PV, Han HH. Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life. Vaccine. 2011 Aug 26;29(37):6335-41. doi: 10.1016/j.vaccine.2011.05.017. Epub 2011 Jun 2. | |
| Background | Kawamura N et al. Efficacy of Human Rotavirus (G1P[8] strain) Vaccine (HRV) RIX4414 in Japanese Infants during the Two-year Efficacy Follow-up Period. Abstract presented at the 114th Annual Meeting of Japan Pediatric Society (JPS). Tokyo, Japan, 12-14 August 2011. | ||
| Background | Kawamura N et al. Efficacy of human rotavirus vaccine RIX4414 in Japanese infants from 2 weeks post dose 2 up to data lock point. Abstract presented at the 28th meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010. | ||
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 107625 | Informed Consent Form | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotarix Group | Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule. |
| FG001 | Placebo Group | Subjects received 2 oral doses of placebo according to a 0, 1 month schedule. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
Two-dose oral administration. |
|
| Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type | Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). | From 2 weeks after Dose 2 up to 2 years of age |
| Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types | Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). | From 2 weeks after Dose 2 up to 2 years of age |
| Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains | Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. | From 2 weeks after Dose 2 up to 2 years of age |
| Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains | Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). | From Dose 1 up to 2 years of age |
| Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration | Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL). | 2 months after Dose 2 |
| Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies | Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative. | 2 months after Dose 2 |
| Number of Subjects Reporting Solicited Symptoms | Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting. | During the 8-day follow-up period after each dose |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | During the 31-day follow-up period after each dose |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | Serious adverse events (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. | Up to 2 years of age |
| Chiba |
| 275-8580 |
| Japan |
| GSK Investigational Site | Fukuoka | 802-8533 | Japan |
| GSK Investigational Site | Hiroshima | 720-8520 | Japan |
| GSK Investigational Site | Hiroshima | 730-8518 | Japan |
| GSK Investigational Site | Hiroshima | 730-8798 | Japan |
| GSK Investigational Site | Hiroshima | 734-8530 | Japan |
| GSK Investigational Site | Hiroshima | 737-0811 | Japan |
| GSK Investigational Site | Hokkaido | 003-0021 | Japan |
| GSK Investigational Site | Hokkaido | 065-0033 | Japan |
| GSK Investigational Site | Kagawa | 765-8501 | Japan |
| GSK Investigational Site | Kanagawa | 247-8533 | Japan |
| GSK Investigational Site | Miyagi | 981-3203 | Japan |
| GSK Investigational Site | Miyagi | 983-8520 | Japan |
| GSK Investigational Site | Nagano | 386-8610 | Japan |
| GSK Investigational Site | Nagasaki | 856-8562 | Japan |
| GSK Investigational Site | Niigata | 957-8588 | Japan |
| GSK Investigational Site | Okayama | 701-0204 | Japan |
| GSK Investigational Site | Okayama | 701-1192 | Japan |
| GSK Investigational Site | Osaka | 591-8025 | Japan |
| Background |
| Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8. |
| 34788488 | Derived | Bergman H, Henschke N, Hungerford D, Pitan F, Ndwandwe D, Cunliffe N, Soares-Weiser K. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev. 2021 Nov 17;11(11):CD008521. doi: 10.1002/14651858.CD008521.pub6. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107625 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107625 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107625 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107625 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107625 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107625 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rotarix Group | Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule. |
| BG001 | Placebo Group | Subjects received 2 oral doses of placebo according to a 0, 1 month schedule. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | weeks |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains | Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. | The analysis was performed on the according-to-protocol (ATP) cohort for efficacy. | Posted | Number | subjects | From 2 weeks after Dose 2 up to 2 years of age |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains | A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system). | The analysis was performed on the according-to-protocol (ATP) cohort for efficacy. | Posted | Number | subjects | From 2 weeks after Dose 2 up to 2 years of age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type | Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). | The analysis was performed on the according-to-protocol (ATP) cohort for efficacy. | Posted | Number | subjects | From 2 weeks after Dose 2 up to 2 years of age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types | Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). | The analysis was performed on the according-to-protocol (ATP) cohort for efficacy. | Posted | Number | subjects | From 2 weeks after Dose 2 up to 2 years of age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains | Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. | The analysis was performed on the according-to-protocol (ATP) cohort for efficacy. | Posted | Number | subjects | From 2 weeks after Dose 2 up to 2 years of age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains | Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system). | The analysis was performed on the Total Vaccinated cohort. | Posted | Number | subjects | From Dose 1 up to 2 years of age |
|
| ||||||||||||||||||||||||||||||
| Secondary | Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration | Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL). | The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | Units per milliliter (U/mL) | 2 months after Dose 2 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies | Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative. | The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity. | Posted | Number | subjects | 2 months after Dose 2 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Solicited Symptoms | Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting. | The analysis was performed on the Total Vaccinated cohort. | Posted | Number | subjects | During the 8-day follow-up period after each dose |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | The analysis was performed on the Total Vaccinated cohort. | Posted | Number | subjects | During the 31-day follow-up period after each dose |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | Serious adverse events (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. | The analysis was performed on the Total Vaccinated cohort. | Posted | Number | subjects | Up to 2 years of age |
|
|
Not provided
Not provided
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 received 2 oral doses of Rotarix according to a 0, 1 month schedule. | 72 | 508 | 411 | 508 | ||
| EG001 | Placebo Group | Subjects received 2 oral doses of placebo according to a 0, 1 month schedule. | 44 | 257 | 204 | 257 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (unspecified) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Acute tonsilitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Kawasaki's disease | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Breath holding | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Erythema infectiosum | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Weight gain poor | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (unspecified) | Non-systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Non-systematic Assessment |
| |
| Cough | General disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | General disorders | MedDRA | Systematic Assessment |
| |
| Fever | General disorders | MedDRA | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA | Systematic Assessment |
| |
| Loss of appetite | General disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | General 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| 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
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