A Study to Assess the Persistence of Two GBS Antibodies in Women Previously Immunized With a GBS Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01053767
First received: January 19, 2010
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Group B Streptococcus (GBS) Disease
Biological: Group B streptococcus (GBS) vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   20 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053767

Locations
Switzerland
Institute for Pharmacokinetic and Analytical Studies
Via Mastri, 36, CH - 6853 Ligornetto, Switzerland
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01053767     History of Changes
Other Study ID Numbers: V98P2E1
Study First Received: January 19, 2010
Last Updated: December 7, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by Novartis:
Group B streptococcus
GBS
Vaccine

ClinicalTrials.gov processed this record on April 17, 2014