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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01053767
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : December 8, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Group B Streptococcus (GBS) Disease Biological: Group B streptococcus (GBS) vaccine Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Primary Completion Date : August 2010
Study Completion Date : December 2010
Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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
Sponsors and Collaborators
Novartis Vaccines
More Information

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01053767     History of Changes
Other Study ID Numbers: V98P2E1
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

Keywords provided by Novartis ( Novartis Vaccines ):
Group B streptococcus

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs