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

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ClinicalTrials.gov Identifier: NCT01052935
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : June 14, 2017
Novartis Vaccines
Information provided by (Responsible Party):

Brief Summary:
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 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)
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
Study Start Date : January 2010
Primary Completion Date : January 2010
Study Completion Date : October 2010

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 V98P1 study.

Primary Outcome Measures :
  1. 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 ]

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 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.

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): NCT01052935

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

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01052935     History of Changes
Other Study ID Numbers: V98P1E1
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Novartis:
Group B streptococcus

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs