Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine
Year: 2025
Type: article
Abstract: Background The tetravalent dengue vaccine TAK-003 is contraindicated during pregnancy. Pregnant women were excluded from TAK-003 clinical studies; however, some pregnancies occurred unintentionally.Research design and methods This post-hoc analysis of phase 2 and 3 studies, evaluated pregnancy outcomes and neonatal adverse events (AEs), following unintentional vaccination during the time period (‘exposure window’) when women could be pregnant (within 44 days before last menstrual period until the outcome of pregnancyResults Of, 557 reported pregnancies 38 (TAK-003, n = 28/375; placebo, n = 10/182) occurred inside the exposure window. Of these 28 (TAK-003, n = 23; placebo, n = 5) resulted in live births, four resulted in elective terminations (TAK-003, n = 2; placebo, n = 2), five in spontaneous abortions (TAK-003, n = 3; placebo, n = 2) and one unknown outcome (placebo).Of the spontaneous abortions, there was no significant difference between TAK-003 and placebo recipients, or between those occurring within or outside the exposure window Six mothers who received TAK-003 in the exposure window and two neonates experienced serious AEs; none considered TAK-003 related.Conclusions This post-hoc analysis found no evidence of increased adverse pregnancy outcomes following unintentional TAK-003 vaccination occurring inside the exposure window compared with placebo.Clinical trial registration The clinical trials from which data were extracted are registered at www.clinicaltrials.gov;(identifiers are NCT02193087, NCT01511250, NCT02302066, NCT02425098, NCT03746015, NCT02747927, NCT03999996, NCT03423173, NCT03342898, NCT03771963, NCT04313244, NCT02948829, NCT035252119, NCT03341637).
Source: Expert Review of Vaccines
Institution: Takeda (Japan)
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4408547235