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| ID | Type | Description | Link |
|---|---|---|---|
| 444563/005 (Rota-005) | |||
| 444563/023 (Rota-023) | |||
| 444563/028 (Rota-028) | |||
| 444563/029 (Rota-029) | |||
| 102247 (Rota-036) | |||
| 106481 (Rota-054) |
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This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.
Serum samples collected from 6 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRV Group | Subjects who had received 2 doses of HRV vaccine in previous studies. |
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| Placebo Group | Subjects who had received 2 doses of placebo in previous studies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum sample | Procedure | Serum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study. Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity rates for anti-PCV-1 antibodies. | At 1-2 months post dose 2 of HRV vaccine or placebo. | |
| Seroconversion rates for anti-PCV-1 antibodies. | At 1-2 months post dose 2 of HRV vaccine or placebo. |
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Inclusion Criteria:
Not applicable as no subjects will be actively enrolled in this study, only the sera samples of the subjects who were a part of previously conducted trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:
Exclusion Criteria:
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Infants aged 6 to 12 weeks from 6 previously completed clinical trials, who received 2 doses of either Rotarix™ 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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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Serum samples
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