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

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.

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Key information

Conditions

Group B Streptococcus (GBS) Disease Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Disease Attributes Guillain-Barre Syndrome Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders

Age range

20 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Institute for Pharmacokinetic and Analytical Studies

Via Mastri, 36, CH - 6853 Ligornetto, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group B streptococcus (GBS) vaccine

Biological

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jan 21, 2010
Registry last updated: Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed