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U.S. Department of Health and Human Services

About FDA

Vaccine Database Initiative

Description: This project tracks the conversion of vaccine legacy clinical trial data into a standardized format and stores it in a newly created database so that OBE staff and other CBER staff can evaluate new approaches to analysis of safety and efficacy across studies.

Accomplishment: TBD

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Phase 1: Confirm reproducibility for all studies

6/30/2011

Completed 6/28/2011

B. Phase 2: Evaluate and determine which datasets can be pooled and create a new, larger dataset

9/30/2011

Completed 9/30/2011

C. Phase 3: Launch new exploratory studies on autoimmune conditions and detecting unexpected and rare adverse events

12/30/2011

Completed 12/19/2011

D. Phase 4: Perform subgroup analysis by gender on combined data.

1/31/2012

Completed 1/31/2012

E. Assess how combining data from multiple studies can contribute to improved public health outcomes

3/30/2012

(5/30/2012)

Completed 5/30/2012

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.