Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-04-30

Brief Summary

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Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent for this duration of immunity study to provide up to two additional blood samples. SBA \& IgG testing will be done on these samples taken at 6 \& 12 months. The sites participating in this duration of immunity study are the same sites participating in the 6108A1-500 study.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm 1

Includes subjects from a trial involving experimental vaccine and an active comparator vaccine. Comparator is Twinrix (not a MnB vaccine) and thus is comparator for safety but not immunogencity

Group Type EXPERIMENTAL

Blood Sampling

Intervention Type PROCEDURE

Blood draws at 6 and 12 months following end of 6108A1-500 trial.

Interventions

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Blood Sampling

Blood draws at 6 and 12 months following end of 6108A1-500 trial.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Completed study 6108A1-500 (three doses administered and visit 9 completed).

Exclusion Criteria

* Bleeding diathesis or condition associated with prolonged bleeding time.
* Any clinically significant chronic disease that, in the investigators judgment may be worsened by blood draw.

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes