Trials / Completed
CompletedNCT01052935
A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS Vaccine
A Phase I Extension Study to Assess the Long-Term Persistence of GBS Serotype Ia Antibodies in Women Previously Immunized With a GBS Ia Crm-Glycoconjugate Vaccine
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Novartis · Industry
- Sex
- Female
- Age
- 20 Years – 42 Years
- Healthy volunteers
- Accepted
Summary
This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody levels.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Group B streptococcus (GBS) vaccine | 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 V98P1 study. |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2010-01-01
- Completion
- 2010-10-01
- First posted
- 2010-01-21
- Last updated
- 2017-06-14
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT01052935. Inclusion in this directory is not an endorsement.