A Phase I, Randomized, Single-Blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00657683

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine. Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events and serious adverse events. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To study the magnitude and durability of GBS-specific antibody responses over 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy females 18 through 40 years of age;
have provided written informed consent after the nature of the study has been explained;
are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period);
are in good health as determined by: medical history, physical assessment, clinical judgment of the investigator

Exclusion Criteria:

unwilling or unable to give written informed consent to participate in the study;
pregnant (serum pregnancy test)
unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization
nursing (breastfeeding) mothers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657683

Locations

Switzerland
Institute for Pharmacokinetic and Analytical Studies, I.P.A.S. S.A.
Ligornetto, Switzerland, 6853

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

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

Keywords provided by Novartis:

GBS
GBS prevention

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009