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

Group B Streptococcus (GBS) Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053767
• Other study ID #: V98P2E1
• Status: Completed
• Phase: Phase 1
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Group B Streptococcus (GBS) Disease

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Institute for Pharmacokinetic and Analytical Studies	Via Mastri, 36	CH - 6853 Ligornetto

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24- months post last injection from V98P2

External Links

•   Results for V98P2E1 on the Novartis Clinical Trials website