A Study to Assess the Persistence of a GBS Antibody 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 Serotype Ia Antibodies in Women Previously Immunized With a GBS Ia Crm-Glycoconjugate Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052935
• Other study ID #: V98P1E1
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2010
• Last updated: June 9, 2017
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: June 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2010
• Est. primary completion date: January 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 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.

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 V98P1 study.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	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 V98P1 GMCs, GMRs and associated 95% confidence intervals will also be determined		24- months post last injection from V98P1

External Links

•   Results for V98P1E1 from the Novartis Clinical Trials website