A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS Vaccine
|ClinicalTrials.gov Identifier: NCT01052935|
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Group B Streptococcus (GBS) Disease||Biological: Group B streptococcus (GBS) vaccine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Extension Study to Assess the Long-Term Persistence of GBS Serotype Ia Antibodies in Women Previously Immunized With a GBS Ia Crm-Glycoconjugate Vaccine|
|Study Start Date :||January 2010|
|Primary Completion Date :||January 2010|
|Study Completion Date :||October 2010|
No Intervention: Arm 1
This is a phlebotomy study.
Biological: Group B streptococcus (GBS) vaccine
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 V98P1 study.
- Antibody (Ab) response data at 24-months after the last injection given in study V98P1 GMCs, GMRs and associated 95% confidence intervals will also be determined [ Time Frame: 24- months post last injection from V98P1 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052935
|Institute for Pharmacokinetic and Analytical Studies|
|Via Mastri, 36, CH - 6853 Ligornetto, Switzerland|