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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01053767

Enrollment

Registered

2010-01-21

Start date

2010-01-31

Completion date

2010-12-31

Last updated

2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Group B Streptococcus (GBS) Disease

Keywords

Group B streptococcus, GBS, Vaccine

Brief 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.

Interventions

BIOLOGICALGroup 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 42 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026