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

Novartis

Status and phase: Completed; Phase 1

Conditions: Group B Streptococcus (GBS) Disease

Treatments: Biological: Group B streptococcus (GBS) vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01052935

V98P1E1

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 20 to 42 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Arm 1

No Intervention group

Description:

This is a phlebotomy study.

Treatment:

Biological: Group B streptococcus (GBS) vaccine