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| ID | Type | Description | Link |
|---|---|---|---|
| 444563/022 | Other Identifier | GSK | |
| 444563/033 | Other Identifier | GSK | |
| 103477 | Other Identifier | GSK | |
| 104480 | Other Identifier | GSK |
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This study aims to test the clinical samples (stool and serum) previously collected during clinical development of HRV vaccine, to identify if there is any evidence of PCV-1 replication and/or immune response to the PCV-1 in vaccinated infants.
Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine (Rotarixâ„¢) are used in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRV Group | Subjects received two or three doses of HRV in previous studies. |
| |
| Placebo Group | Subjects received two or three doses of placebo in previous studies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool sample | Procedure | Stool samples collected at pre-determined time points in previous studies will be analysed to detect the presence of PCV-1 DNA and pattern of detection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of PCV-1 DNA and pattern of detection in the stool samples collected | At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination) | |
| Presence of serum anti-PCV-1 antibody | At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination) |
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Inclusion criteria:
Exclusion criteria:
- Not applicable
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Infants aged 6 to 12 weeks from 4 previously conducted clinical trials, who received 2 or 3 doses of either Rotarixâ„¢ or Placebo
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27657348 | Derived | Han HH, Karkada N, Jayadeva G, Dubin G. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix: A retrospective laboratory analysis. Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244. doi: 10.1080/21645515.2016.1231262. |
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Serum and stool samples
| Serum sample | Procedure | Serum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody. |
|
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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