Vaccine Use in Pregnancy

Objectives

To demonstrate the feasibility of identifying and validating vaccine exposure in pregnancy.

Methods

Two study designs were used. 1) Women who contacted the Research Coordinating Center of OTIS (a pregnancy registry) were invited to participate; those who agreed were asked details about their vaccine. 2) Exposure information was gathered within an ongoing case-control surveillance program, Pregnancy Health Invertiew Study (Birth Defects Study). The questionnaire was modified to include specific questions about vaccine exposure.

Results

We have demonstrated that it is possible to not only identify vaccine exposure in pregnancy but also to obtain important vaccine details. This is true for vaccines administered in both traditional and non-traditional settings.

We were further able to distinguish thimerosal-free from thimerosal-containing vaccine, a potentially important factor in assessing risks and safety. We found that almost one-third of flu vaccine was administered in non-traditional settings, highlighting the importance of documenting exposures outside of computerized health care databases.

Investigators and Study Staff

Investigators:

Allen A. Mitchell, M.D., Principal Investigator
Carol Louik, Sc.D., Co-Investigator
Martha M. Werler, Sc.D., Co-Investigator

Study Staff:

Dawn Jacobs, R.N., M.P.H., Project Coordinator
Fiona Rice, M.P.H., Program Coordinator
Paula Wilder, Research Coordinator
Rita Krolak, R.N., Research Coordinator
Nastia Dynkin, Computer Programmer

Nurse Interviewers:

Clare Coughlin, R.N.
Moira Quinn, R.N.
Kathleen Sheehan, R.N.
Mary Thibeault, R.N.
Laurie Cincotta, R.N.
Nancy Rodriguez, Interpreter
Laine Fletcher, Interpreter
Ileana Gatica, Interpreter

Research Assistants:

Joan Shander
Nicole Gonzalez
Lindsay Andrus

Study Details

Source of Funding:

Sanofi Pasteur, Inc.

Study Period:

September 2006 to February 2008