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

• Sponsor: Novartis Vaccines (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00657683
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 3.8

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: Monovalent GBS-CRM glycoconjugate vaccine; Biological: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 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 a Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: Monovalent GBS-CRM glycoconjugate vaccine; 1 dose of GBS conjugate vaccine
Placebo Comparator: 2	Biological: Placebo; 1 dose of placebo

Outcome Measures

Primary Outcome Measures

1. 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. [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, 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

Locations

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

• Responsible Party: Novartis Vaccines
• ClinicalTrials.gov Identifier: NCT00657683
• Other Study ID Numbers: V98P1
• First Posted: Apr 14, 2008
• Last Update Posted: Dec 8, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Novartis Vaccines: GBS; GBS prevention

Study Results

No Results Posted as of Dec 8, 2011