Maternal Outcomes following RSVpreF Vaccination during prEgnancy (MORE)

Study identification

• EU PAS number:
  EUPAS1000000923
• Study ID:
  1000000923
• Official title and acronym:
  Maternal Outcomes following RSVpreF Vaccination during prEgnancy (MORE)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will evaluate the availability of existing real-world data from Kaiser Permanente Southern California (KPSC) documenting the burden of RSV disease in pregnant and postpartum women. These findings are informative to future investigations into the potential direct benefits of RSVpreF vaccination for pregnant and postpartum women.; ; This retrospective cohort study will use KPSC databases from October 2016 onward, with emphasis on September 2023 to the latest data when RSVpreF vaccine became available. The main cohort includes women aged 18–49 years with pregnancy records at KPSC. For exploratory purposes, a mother-infant sub-cohort of postpartum women with linked infant health records and confirmed RSV infection in children under one year will be created. ARI and LRTD episodes within this group will help assess under-ascertainment of RSV-related respiratory infections in postpartum women.
• Study status:
  Planned

Research institutions and networks

Institutions

Kaiser Permanente Southern California (KPSC)

Study timelines

Date when funding contract was signed

Planned:29/01/2026

Actual:29/01/2026

Study start date

Planned:30/06/2026

Data analysis start date

Planned:01/07/2026

Date of final study report

Planned:31/03/2027

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable