A Study to Assess the Persistence of Two GBS Antibodies in Women Previously Immunized With a GBS Vaccine
|ClinicalTrials.gov Identifier: NCT01053767|
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : December 8, 2011
|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 :||95 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 Serotypes Ib and III Antibodies in Women Previously Immunized With a GBS Ib and III Crm-Glycoconjugate Vaccine|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||December 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 V98P2 study.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053767
|Institute for Pharmacokinetic and Analytical Studies|
|Via Mastri, 36, CH - 6853 Ligornetto, Switzerland|