Influenza Vaccines and Birth Outcomes Protocol (PRISM)

Project Title Influenza Vaccines and Birth Outcomes Protocol (PRISM)
Date Posted
Friday, January 20, 2017
Status
In progress
Deliverables
Description

This protocol describes the PRISM program’s efforts to develop a large database to be used for retrospective studies of potential adverse events following vaccination in pregnant women by linking mothers with infants and by incorporating an additional data source, specifically birth certificate data. Though not under investigation per se, influenza vaccines and oral clefts will be used as test cases to evaluate the capabilities of the new methods and data infrastructure. Medical record review will be conducted to confirm case status, confounders, and gestational age at delivery to better understand the strengths and limitations of using electronic data for surveillance. The results of this evaluation will be used to determine the feasibility of pregnancy outcome and birth outcome surveillance within Mini-Sentinel’s PRISM program and to evaluate the novel data linkages required to conduct such surveillance.

The Mini-Sentinel Operations Center posted this protocol for public comment from February 25, 2013, through March 11, 2013. A revised version was approved for implementation by FDA on December 5, 2014. A log of changes is included in the revised protocol (v2).  A second revised version was approved for implementation by FDA on January 3, 2017. A log of changes is included in the revised protocol (v3).

Medical Product
influenza vaccines
Health Outcome
Cleft lip without cleft palate
cleft palate without cleft lip
or cleft lip with cleft palate
Population / Cohort
Specified women ages 10-55
Time Period
Jan 2004-May 2012
Project Type
Safety Analyses
Assessment Type
Protocol
Workgroup Leader(s)

Alison Kawai, ScD and Grace Lee, MD, MPH, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA; Azadeh Shoaibi, MS, MHS, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Workgroup Members

Carolyn Balsbaugh, MPH, Sandra Feibelmann, MPH, Madelyn Pimentel, Megan Reidy, MPH, Lauren Zichittella, MS, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA; Susan Andrade, Meyers Primary Care Institute, a joint endeavor of Fallon Community Health Plan, Reliant Medical Group, and University of Massachusetts Medical School, Worcester, MA; Faith Barash, MD, MPH, Laura Polakowski, MD, MPH, Office of Biostatistics and Epidemiology Center for Biostatistics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD; Mano Selvan, PhD, Humana, Louisville, KY; Nancy Lin, ScD, OptumInsight Inc, Waltham, MA; Cheryl McMahill-Walraven, MSW, PhD, Aetna Inc, Blue Bell, PA; Nandini Selvam, PhD, MPH, HealthCore, Inc, Alexandria, VA

Data Sources
Mini-Sentinel Distributed Database, immunization registries in Florida, Michigan, Minnesota, New York City, New York State, Pennsylvania, Virginia, and Wisconsin, and vital events registries in to-be-determined states/cities
FDA Center
CBER