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This study looks at the body's immune response to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P2 study. Blood will be drawn and evaluated for GBS antibody levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | No Intervention | This is a phlebotomy study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group B streptococcus (GBS) vaccine | Biological | No vaccine will be administered in this study. Only one study visit is required. Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P2 study. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody (Ab) response data at 24-months after the last injection given in study V98P2 GMCs, GMRs and associated 95% confidence intervals will also be determined. | 24- months post last injection from V98P2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Pharmacokinetic and Analytical Studies | Via Mastri, 36 | CH - 6853 Ligornetto | Switzerland |
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| ID | Term |
|---|---|
| D020275 | Guillain-Barre Syndrome |
| D004194 | Disease |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |