Moderna mRNA-1273 vaccine Clinical Study Protocol [pdf]

Clinical study protocols are usually confidential and not publicly available. I see a lot of discussion on HN about clinical trials, so this is a good opportunity to dig into the details if people are interested.

In terms of measuring efficacy, it's explicitly spelled out.

- All participants may have up to 7 scheduled clinic visits, including Screening, Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759.

- Surveillance for COVID-19 will be performed through weekly contacts with the participant via a combination of telephone calls and completion of an eDiary starting at Day 1 through the end of the study. Participants with symptoms of COVID-19 lasting at least 48 hours (except for fever and/or respiratory symptoms) will return to the clinic or will be visited at home by medically qualified site staff within 72 hours (an “Illness Visit”) to collect an NP swab sample for RT-PCR testing for SARS-CoV-2 and other respiratory pathogens, or alternatively, if a clinic or home visit is not possible, will submit a saliva (or nasal swab) sample for SARS-CoV-2 RT-PCR testing.

- In the event that success criteria are met either at the time of the interim analyses or when the total number of cases toward the primary endpoint have accrued, participants will continue to be followed in a blinded fashion until Month 25.