Methodologic approaches in studies using real-world data to measure pediatric safety and effectiveness of vaccines administered to pregnant women: a scoping review protocol.

OBJECTIVE: This scoping review aims to map studies using real-world data (RWD) to measure pediatric safety and effectiveness of vaccines administered to pregnant women. INTRODUCTION: In the United States, two vaccines are recommended for all pregnant women to prevent illness in the infant: inactivated influenza vaccine (recommended since 2004) and the combined tetanus-diphtheria-acellular pertussis (Tdap) vaccine (recommended since 2013). Because of the ethical constraints in conducting randomized clinical trials to measure the effects on the infant, there is great interest in using electronic health care data or administrative claims data to study the effects of maternal immunization on the infant's health, and it is anticipated that such studies may be submitted to support regulatory decision-making. This scoping review will map the studies conducted to date that address these questions and provide a context for considering the regulatory issues that may arise in the future. INCLUSION CRITERIA: Studies that report on pregnant women receiving immunization and the effectiveness or safety outcomes in their infants will be included. Study participants may be from any population or country, of any reproductive age, and with any health status. Studies will be included if they use real-world data (from electronic health records, administrative claims, pharmacy benefit records, or registries). METHODS: An electronic search of PubMed and Embase will identify citations for screening. The search will be limited to studies published in English during the preceding 10 years. Two reviewers will screen citations in a two-step process (titles and abstracts, then full-text articles), and two reviewers will extract data for summary and synthesis.