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The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator.
One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study.
The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo.
The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotarix Group | Experimental | All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). |
|
| Placebo Group | Placebo Comparator | All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarix | Biological | Two-dose oral vaccination. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo. | Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample. | On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Human Rotavirus (HRV) Shedding Per Study Group. | Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen. | From Day 0 up to Week 13. |
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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 | Santo Domingo | Dominican Republic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22008819 | Background | Rivera L, Pena LM, Stainier I, Gillard P, Cheuvart B, Smolenov I, Ortega-Barria E, Han HH. Horizontal transmission of a human rotavirus vaccine strain--a randomized, placebo-controlled study in twins. Vaccine. 2011 Nov 28;29(51):9508-13. doi: 10.1016/j.vaccine.2011.10.015. Epub 2011 Oct 18. |
| 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 |
|---|---|---|---|
| 106260 | Informed Consent 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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Within each pair of twins enrolled in the study, one subject was assigned to the Rotarix Group and one to the Placebo Group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotarix Group | All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). |
| FG001 | Placebo Group | All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotarix Group | All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). |
| BG001 | Placebo Group |
| 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 | Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo. | Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample. | The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity. | Posted | Number | subjects | On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3. |
|
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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 | All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | 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 |
| 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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| Placebo |
| Biological |
Two-dose oral administration. |
|
| Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission. | Dissimilar amino acid substitutions in the HRV vaccine strain isolated from the twin receiving placebo, when compared to the genetic variation of HRV vaccine strain isolated from the Rotarix vaccine recipients, were counted as genetic variation differences. | During the entire study period (up to Visit 4, Week 17). |
| Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission. | Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission. | During the entire study period (up to Visit 4, Week 17). |
| Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion. | Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose. | At Visit 3 (Week 13). |
| Anti-rotavirus IgA Antibody Concentration. | Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals. | At Visit 3 (Week 13). |
| Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes. | GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting. RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA). | Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs). | An AE is 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. | Within 31 days after any doses. |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs). | A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Up to Visit 4. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 106260 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106260 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106260 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106260 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106260 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106260 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Not vaccinated at Visit 3 |
|
All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). |
| BG002 | Total | Total of all reporting groups |
| Weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
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| Secondary | Duration of Human Rotavirus (HRV) Shedding Per Study Group. | Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen. | The analysis was performed on the According To Protocol analysis for immunogenicity, on the twins whose placebo recipient had at least one stool sample positive for the rotavirus strain. | Posted | Median | Inter-Quartile Range | Number of days | From Day 0 up to Week 13. |
|
|
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| Secondary | Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission. | Dissimilar amino acid substitutions in the HRV vaccine strain isolated from the twin receiving placebo, when compared to the genetic variation of HRV vaccine strain isolated from the Rotarix vaccine recipients, were counted as genetic variation differences. | The analysis was performed on the According To Protocol analysis for immunogenicity, on the twins who received placebo and those who received Rotarix vaccine, in case of transmission. | Posted | Number | Genetic variation difference | During the entire study period (up to Visit 4, Week 17). |
|
|
|
| Secondary | Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission. | Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission. | The analysis was performed on the According To Protocol analysis for immunogenicity, on the twins who received placebo in case of transmission. | Posted | Number | Subjects | During the entire study period (up to Visit 4, Week 17). |
|
|
|
| Secondary | Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion. | Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose. | The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity. | Posted | Number | subjects | At Visit 3 (Week 13). |
|
|
|
| Secondary | Anti-rotavirus IgA Antibody Concentration. | Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals. | The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | U/mL | At Visit 3 (Week 13). |
|
|
|
| Secondary | Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes. | GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting. RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA). | The analyses were performed on the Total Vaccinated Cohort | Posted | Number | subjects | Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE. |
|
|
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | An AE is 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. | The analyses were performed on the Total Vaccinated Cohort | Posted | Number | subjects | Within 31 days after any doses. |
|
|
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| Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs). | A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | The analyses were performed on the Total Vaccinated Cohort | Posted | Number | subjects | Up to Visit 4. |
|
|
|
| 0 |
| 100 |
| 5 |
| 100 |
| 69 |
| 100 |
| EG001 | Placebo Group | All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). | 0 | 100 | 6 | 100 | 71 | 100 |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Bacterial sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA | Non-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 |