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 has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00645346
First received: March 21, 2008
Last updated: December 7, 2011
Last verified: December 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

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 ]

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

  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645346

Locations
Switzerland
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
  More Information

No publications provided

Responsible Party: Novartis Vaccines and Diagnostics s.r.l., Novartis
ClinicalTrials.gov Identifier: NCT00645346     History of Changes
Other Study ID Numbers: V98P2
Study First Received: March 21, 2008
Last Updated: December 7, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by Novartis:
GBS

ClinicalTrials.gov processed this record on August 28, 2014