Abracadabra
kiwifarms.net
- Joined
- May 10, 2021
The Moderna study is about a third dose of the vaccine:
“This is an optional third mRNA-1273 vaccination substudy, in subjects 18 years of age and older, who received both the first and second mRNA-1273 vaccinations in the main study and meet all other substudy eligibility criteria. This optional third mRNA-1273 vaccination substudy is designed to assess safety, reactogenicity, and immunogenicity through 12 months post third vaccination (Day 731).”
Approval of vaccines is dependent on primary completion date, not study completion date.
J&J Vaccine
| Actual Primary Completion Date : | January 22, 2021 |
| Estimated Study Completion Date : | January 2, 2023 |
“The proposed rule also noted that the current implementation of ClinicalTrials.gov uses the term “primary completion date” to refer to “completion date,” as defined in section 402(j)(1)(A)(v) of the PHS Act. This was done in the data bank to alert those submitting data to ClinicalTrials.govunder section 402(j) of the PHS Act that the definition of “completion date” differs from that of the term “study completion date,” which refers to the date on which the last subject makes the last visit as part of the clinical trial (commonly referred to as Last Patient Last Visit (LPLV)) and is also collected by ClinicalTrials.gov as an optional data element [Ref. 85].”
Has AstraZeneca been approved in the US? ClinicalTrials.gov is for vaccine approval in the US.
