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

This study is currently recruiting participants.

Verified by Novartis, March 2008

First Received: March 21, 2008 No Changes Posted

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00645346

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: GBS 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 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 [ 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: Yes ]

Estimated Enrollment:	130
Study Start Date:	February 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Subjects will receive either 5, 10 or 20 mcg of the vaccine	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.
2: Placebo Comparator Subjects will receive placebo control	Biological: Placebo Subjects will receive one dose of placebo

Eligibility

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

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: NCT00645346

Contacts

Contact: Novartis Vaccines

+1 800 244 7668

Locations

Switzerland
Institute for Pharmacokinetic and Analytical Studies I.P.A.S.	Recruiting
Ligornetto, Switzerland, 6853
Contact: Novartis Vaccines 1 800 244 7668
Principal Investigator: Novartis Vaccines

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Vaccines and Diagnostics s.r.l. )
Study ID Numbers:	V98P2
Study First Received:	March 21, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00645346 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by Novartis:

GBS

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 10, 2009