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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01052935
First received: January 19, 2010
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 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 Serotype Ia Antibodies in Women Previously Immunized With a GBS Ia 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 V98P1 GMCs, GMRs and associated 95% confidence intervals will also be determined [ Time Frame: 24- months post last injection from V98P1 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: January 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 V98P1 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 V98P1 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 V98P1.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052935

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01052935     History of Changes
Other Study ID Numbers: V98P1E1
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 July 24, 2014