This study is a Phase 4, non-interventional, prospective pregnancy registry designed to evaluate the safety of VIMKUNYA® (chikungunya virus-like particle vaccine) when administered up to 28 days prior to conception or at any time during pregnancy. As pregnant women were not included in pre-authorization clinical trials, there is limited information available on the safety of VIMKUNYA in this population. This registry aims to address this gap by collecting real-world data on maternal, pregnancy, and infant outcomes following vaccine exposure.
The study population includes pregnant women in the United States, Europe, and other countries where VIMKUNYA is available, along with their offspring. Participants will be enrolled prospectively after vaccine exposure and followed through pregnancy and up to one year after delivery. Data will be collected via structured questionnaires at predefined timepoints, including enrolment, delivery, neonatal period, and infant follow-up visits.
The primary objective is to describe pregnancy outcomes, including full-term birth, preterm birth, spontaneous abortion, stillbirth, and congenital anomalies. Secondary objectives include characterization of neonatal and infant outcomes such as birth weight, gestational age, neonatal complications, growth, neurodevelopment, and survival up to one year of age.
Data will be analyzed descriptively, focusing on frequencies and proportions of outcomes among exposed pregnancies. As this is an observational registry without an internal comparator group, findings will be interpreted in the context of available background rates from external sources. The study is expected to run for approximately five years and will support postmarketing safety evaluation for regulatory authorities.