- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00645346
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
December 7, 2011 updated by: Novartis Vaccines
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ligornetto, Switzerland, 6853
- Institute for Pharmacokinetic and Analytical Studies I.P.A.S.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Subjects will receive either 5, 10 or 20 mcg of the vaccine
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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.
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Placebo Comparator: 2
Subjects will receive placebo control
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Subjects will receive one dose of placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine
Time Frame: 1 month
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1 month
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To study the magnitude and durability of GBS-specific antibody responses over 12 months.
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
March 21, 2008
First Submitted That Met QC Criteria
March 21, 2008
First Posted (Estimate)
March 27, 2008
Study Record Updates
Last Update Posted (Estimate)
December 8, 2011
Last Update Submitted That Met QC Criteria
December 7, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- V98P2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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