![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Novartis Novartis Vaccines |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00657683 |
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.
Condition | Intervention | Phase |
---|---|---|
Invasive Group B Streptococcus (GBS) Disease |
Biological: Monovalent GBS-CRM glycoconjugate vaccine Biological: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I, Randomized, Single-Blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age |
Enrollment: | 65 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: Monovalent GBS-CRM glycoconjugate vaccine
1 dose of GBS conjugate vaccine
|
2: Placebo Comparator |
Biological: Placebo
1 dose of placebo
|
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |
Institute for Pharmacokinetic and Analytical Studies, I.P.A.S. S.A. | |
Ligornetto, Switzerland, 6853 |
Study Chair: | Novartis Vaccines | Novartis Vaccines |
Responsible Party: | Novartis Vaccines ( Novartis ) |
Study ID Numbers: | V98P1 |
Study First Received: | March 27, 2008 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00657683 |
Health Authority: | Switzerland: Swissmedic |
GBS GBS prevention |
Healthy |