Trials / Completed
CompletedNCT00645346
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 130 (actual)
- Sponsor
- Novartis Vaccines · Industry
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GBS glycoconjugate vaccine | Study subjects will receive either GBS conjugate vaccine or placebo. Total study size is 65. Study subjects will be followed for a total of 12 months after their last vaccination. |
| BIOLOGICAL | Placebo | Subjects will receive one dose of placebo |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2009-05-01
- Completion
- 2009-07-01
- First posted
- 2008-03-27
- Last updated
- 2011-12-08
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT00645346. Inclusion in this directory is not an endorsement.