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
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 April 23, 2014