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The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group HRV Lot A | Experimental |
| |
| Group HRV Lot B | Experimental |
| |
| Group HRV Lot C | Experimental |
| |
| Group Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarix | Biological | Two oral doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs). | Two months after Dose 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects. | Two months after Dose 1. | |
| Seroconversion rates to anti-rotavirus IgA antibody | Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects). |
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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 | Cali Colombia | Colombia | ||||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Lopez P, Herrera JFG, Cervantes Y, et al. Three consecutive production lots of the human monovalent RIX4414 G1P(8) rotavirus vaccine, Rotarixâ„¢ induce a consistent immune response in Latin American infants. Proc 4th World Congress Pediatr Infect Dis, Warsaw, Poland, 2005. |
| 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 |
|---|---|---|---|
| 444563/033 | Individual Participant Data Set | 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 | 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 oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles. |
|
| Vaccine take rates in a subset of subjects. | Two months after each dose |
| Presence of rotavirus in stool samples in a subset of subjects | On the day of each vaccination and on planned days following each vaccination. |
| For each type of solicited symptom, occurrence of the symptom | During the 8-day follow-up period after each vaccine dose |
| Occurrence of unsolicited symptoms | During the 31-day follow-up period after each vaccine dose. |
| Occurrence of serious adverse events | Throughout the study period. |
| Mexico City |
| 14050 |
| Mexico |
| GSK Investigational Site | Lima | Lima | Peru |
| GSK Investigational Site |
For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/033 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/033 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/033 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/033 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/033 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |