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NCT00518492 Clinical Trial

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

Healthy Clinical Trial

Official title:
Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00518492
Other study ID # 6108A1-1002
Secondary ID
Status Completed
Phase Phase 1
First received August 16, 2007
Last updated September 15, 2009
Start date August 2007
Est. completion date April 2008

Study information
Verified date September 2009
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 25 Years
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immunogenicity at 6 and 12 months post 6108A1-500 study. 6 and 12 months No
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