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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

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ClinicalTrials.gov Identifier: NCT00657683
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : December 8, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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Study Type : Interventional  (Clinical Trial)
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 : December 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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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. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. To study the magnitude and durability of GBS-specific antibody responses over 12 months. [ Time Frame: 12 months ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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, 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657683


Locations
Switzerland
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00657683     History of Changes
Other Study ID Numbers: V98P1
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

Keywords provided by Novartis ( Novartis Vaccines ):
GBS
GBS prevention

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs