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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Procedure: Blood Sampling

Study type: Interventional

Funder types: Industry

Identifiers

NCT00518492

6108A1-1002

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Arm 1

Experimental group

Description:

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

Treatment:

Procedure: Blood Sampling