- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01053767
A Study to Assess the Persistence of Two GBS Antibodies in Women Previously Immunized With a GBS Vaccine
February 8, 2020 updated by: Novartis Vaccines
A Phase I Extension Study to Assess the Long-Term Persistence of GBS Serotypes Ib and III Antibodies in Women Previously Immunized With a GBS Ib and III Crm-Glycoconjugate Vaccine
This study looks at the body's immune response to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P2 study.
Blood will be drawn and evaluated for GBS antibody levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
95
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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CH - 6853 Ligornetto
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Via Mastri, 36, CH - 6853 Ligornetto, Switzerland
- Institute for Pharmacokinetic and Analytical Studies
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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
20 years to 42 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Individuals who have given written consent.
- Individuals who participated in V98P2 and received the complete schedule of vaccinations.
Exclusion Criteria:
- Individuals who have not given written consent.
- Subjects who did not receive the complete schedule of vaccination in V98P2.
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Arm 1
This is a phlebotomy study.
|
No vaccine will be administered in this study. Only one study visit is required. Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P2 study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Antibody (Ab) response data at 24-months after the last injection given in study V98P2 GMCs, GMRs and associated 95% confidence intervals will also be determined.
Time Frame: 24- months post last injection from V98P2
|
24- months post last injection from V98P2
|
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
January 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
January 19, 2010
First Submitted That Met QC Criteria
January 19, 2010
First Posted (Estimate)
January 21, 2010
Study Record Updates
Last Update Posted (Actual)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 8, 2020
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- V98P2E1
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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