NCT01053767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 11, 2020

Status Verified

December 1, 2011

Enrollment Period

7 months

First QC Date

January 19, 2010

Last Update Submit

February 8, 2020

Conditions

Group B Streptococcus (GBS) Disease

Keywords

Group B streptococcusGBSVaccine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Arm 1

NO INTERVENTION

This is a phlebotomy study.

Biological: Group B streptococcus (GBS) vaccine

Interventions

Group B streptococcus (GBS) vaccineBIOLOGICAL

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.

Arm 1

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals who have given written consent.
  • Individuals who participated in V98P2 and received the complete schedule of vaccinations.

You may not qualify if:

  • Individuals who have not given written consent.
  • Subjects who did not receive the complete schedule of vaccination in V98P2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Pharmacokinetic and Analytical Studies

Via Mastri, 36, CH - 6853 Ligornetto, Switzerland

Location

MeSH Terms

Conditions

Guillain-Barre SyndromeDisease

Interventions

Vaccines

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 21, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

February 11, 2020

Record last verified: 2011-12

Locations

CH(1)