Study Interventions and Procedures
immune-mediated diseases
ADVERSE EVENTS
The composition of RZV and mRNA-1273 is provided in the Anti-gE antibodies were measured using an enzyme-linked immunosorbent assay at GSK [Solicited local and systemic adverse events (AEs) with onset within 7 days after each vaccination were recorded using electronic diaries. Unsolicited AEs were recorded for 30 days after each vaccination. Serious adverse events (SAEs), intercurrent medical conditions, potential immune-mediated diseases (pIMDs), pregnancies, AEs of special interest (AESIs), and cases of COVID-19 and HZ were collected up to 6 months after RZV2. All solicited AEs were considered causally related to study vaccination. Causal relationship to vaccination of all other AEs was assessed by the investigators and independently by the sponsor. A joint safety review team with GSK and Moderna representatives oversaw participant safety. Randomization was temporarily paused as per protocol after 10% of participants were vaccinated and safety data were collected for 7 days postvaccination.The protocol-defined list of AESIs, AE intensity grading table, causality assessment criteria by the investigator, and protocol-defined study holding rules are provided in the 