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

• Sponsor: Novartis Vaccines (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00645346
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Group B Streptococcus (GBS) Disease	Biological: GBS glycoconjugate vaccine; Biological: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• 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
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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.
Placebo Comparator: 2 Subjects will receive placebo control	Biological: Placebo; Subjects will receive one dose of placebo

Outcome Measures

Primary Outcome Measures

1. To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine [1 month]

Secondary Outcome Measures

1. To study the magnitude and durability of GBS-specific antibody responses over 12 months. [12 months]

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	Institute for Pharmacokinetic and Analytical Studies I.P.A.S.	Ligornetto		Switzerland	6853

Sponsors and Collaborators

• Novartis Vaccines

Investigators

• Study Chair: Novartis Vaccines, Novartis Vaccines

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00645346
• Other Study ID Numbers: V98P2
• First Posted: Mar 27, 2008
• Last Update Posted: Dec 8, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by , ,: GBS

Study Results

No Results Posted as of Dec 8, 2011