Trial EudraCT, 2022-000063-51; NCT05249829
Publication Lee I, medRxiv, 2023
Dates: 2022-02-16 to 2022-03-24
Funding: Private (Moderna, Inc.)
Conflict of interest: Yes
Multicenter / UK |
Follow-up duration (months): *
|50 mcg mRNA-1273.529=367
50 mcg mRNA-1273=357
1 IM dose of 50 mcg mRNA-1273.529, at least 90 days (median 4.0 months) after 1st boost with a mRNA vaccine + any prime vaccination.
1 IM dose of 50 mcg mRNA-1273, at least 90 days (median 4.1 months) after 1st boost with a mRNA vaccine + any prime vaccination.
|Characteristics of participants|
Type of participants: Aged at least 16 years including healthy, elderly and/or stable co-morbidities
Pregnant women: 0
Immunocompromized patients: 0
Age range: 19-87
|Description of participants|
Healthy or stable co-morbidities, at least 16 years who had previously received 2 injections of an authorized Covid-19 primary series vaccine with or without an mRNA-based booster as the third dose in 28 centres in UK.
|In the register|
1) Geometric Mean Titer (GMT) of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain [Time Frame: Up to Day 85 post-vaccination]; 2) Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [Time Frame: Up to Day 8 (7 days post-vaccination)]; 3) Number of Participants with Unsolicited Adverse Events (AEs) [Time Frame: Up to Day 29 (28 days post-vaccination)]; 4) Number of Participants with Serious AEs (SAEs) [Time Frame: Day 1 to end of study (Day 359)]; 5) Number of Participants with Medically Attended AEs (MAAEs) [Time Frame: Day 1 to end of study (Day 359)]; 6) Number of Participants with AEs Leading to Withdrawal [Time Frame: Day 1 to end of study (Day 359)]; 7) Number of Participants with AEs of Special Interest (AESIs) [Time Frame: Day 1 to end of study (Day 359)].
|In the report|
1) Geometric mean concentration (GMC) of mRNA-1273.529 and mRNA-1273 against the BA.1 strain at Day 29 and Month 3 after study vaccine administration; 2) Ratio of GMC_mRNA-1273.529/GMC_mRNA-1273 against the BA.1 strain at Day 29 and Month 3 after study vaccine administration; 3) Solicited local and systemic reactogenicity ARs during a 7-day follow up period after vaccination; 4) Unsolicited AEs during the 28-day follow-up period after vaccination; 5) SAEs, medically attended AEs (MAAEs), AEs leading to withdrawal, and AEs of special interest (AESIs) from Day 1 to end of study.
Yes, once the trial is complete
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the pre-print article and its supplement, the study registry was used in data extraction and risk of bias assessment. The protocol/statistical analysis plan was not available. Preliminary analysis for a study with ongoing follow-up, to the data cut-off date of August 4, 2022. There is no change from the trial registration in the intervention and control treatments. The registry reported GMT immunogenicity outcomes, however the paper reported GMC. The target sample size (n=3924) specified in the registry for parts 1 and 2 combined was not achieved (n=3548).|