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The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after birth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotarix Group | Experimental | subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarix TM | Biological | Oral, 2 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. | Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (<) 20 U/mL. | 2 months post-Dose 2 (at study Month 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Anti-rotavirus IgA Antibody Concentrations. | Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects. | 2 months post-Dose 2 (at study Month 4) |
| Number of Subjects Reporting Solicited General Symptoms. |
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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 | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24079716 | Derived | Lu CY, Chang LY, Shao PL, Suryakiran PV, Han HH, Huang LM. Immunogenicity, reactogenicity, and safety of a human rotavirus vaccine, Rotarix, in Taiwanese infants who received a dose of hepatitis B immunoglobulin after birth. J Formos Med Assoc. 2013 Sep;112(9):574-7. doi: 10.1016/j.jfma.2012.11.016. Epub 2013 Jan 3. |
| 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 |
|---|---|---|---|
| 114351 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotarix Group | subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months 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 2 and 4 months of age. |
| 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 |
| 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 Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. | Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (<) 20 U/mL. | The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4. | Posted | Number | Subjects | 2 months post-Dose 2 (at study Month 4) |
|
SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) 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 oral doses of Rotarix™ vaccine at 2 and 4 months of age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eczema | Skin and subcutaneous tissue disorders | Non-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 |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting. |
| During the 8-day (Days 0-7) post-vaccination period |
| Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample. | RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample. GE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA). | From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2) |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs). | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. | Within the 31-day (Days 0-30) follow-up period after vaccination |
| Number of Subjects Reporting Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | During the entire study period (from Dose 1 at Day 0 up to Month 4) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114351 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114351 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114351 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114351 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114351 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114351 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Serum Anti-rotavirus IgA Antibody Concentrations. | Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects. | The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4. | Posted | Geometric Mean | 95% Confidence Interval | U/mL | 2 months post-Dose 2 (at study Month 4) |
|
|
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| Secondary | Number of Subjects Reporting Solicited General Symptoms. | Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting. | The Total vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Number | Subjects | During the 8-day (Days 0-7) post-vaccination period |
|
|
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| Secondary | Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample. | RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample. GE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA). | The Total vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Number | Subjects | From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2) |
|
|
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. | The Total vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Number | Subjects | Within the 31-day (Days 0-30) follow-up period after vaccination |
|
|
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | The Total vaccinated cohort included all subjects with at least one vaccine administration documented. | Posted | Number | Subjects | During the entire study period (from Dose 1 at Day 0 up to Month 4) |
|
|
|
| 1 |
| 15 |
| 13 |
| 15 |
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cough | General disorders | Systematic Assessment |
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| Diarrhoea | General disorders | Systematic Assessment |
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| Irritability | General disorders | Systematic Assessment |
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| Loss of appetite | General disorders | Systematic Assessment |
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| Temperature | General disorders | Systematic Assessment |
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| 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.
| Title | Measurements |
|---|
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| Loss of appetite |
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| Temperature (Tympanic on rectal seting (>=38.0°C)) |
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| Vomiting |
|