Trial NCT04649151
Publication Ali K, N Engl J Med, 2021
Dates: 2020-12-09 to 2021-02-28
Funding: Mixed (Moderna; Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA))
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / USA
Follow-up duration (months): 2.8 (median)
100 mcg mRNA-1273 (n=2489)
Placebo (n=1243)
Inclusion criteria
  • Male and female adolescents between the ages of 12 and 17 years
  • considered to be in good general health by the investigators
Exclusion criteria
  • Travel outside of the United States in the 28 days before screening
  • pregnancy or breast-feeding
  • acute illness or fever 24 hours before or at screening
  • previous administration of an investigational vaccine against SARS-CoV-2
  • current treatment with investigational agents for prophylaxis against Covid-19
Interventions
Intervention
2 IM doses of 100 mcg, 28 days apart
Control
2 IM doses of placebo, 28 days apart
Participants
Randomized
3732 participants
Characteristics of participants
Type of participants: Adolescents
N=3732
1915 males
Children: 3726
Pregnant women: 0
Mean age:
Age range: 12-17
Description of participants
Healthy adolescents in 26 centers in the USA
Primary outcome
In the register
1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 36 (7 days after each dose) ]; 2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (28 days after each dose) ]; 3. Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI) of Multisystem Inflammatory Syndrome in Children (MIS-C) [ Time Frame: Up to Day 394 (1 year after second dose) ]; 4. Number of Participants With Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of Protection From COVID-19 [ Time Frame: Day 57 (28 days after second dose) ]; 5. Geometric Mean (GM) of the Serum Ab Level [ Time Frame: Day 57 (28 days after second dose) ]; 6. Seroresponse Rate of Vaccine Recipients [ Time Frame: Day 57 (28 days after second dose) ]
In the report
1. Safety; 2. Reactogenicity; 3. Geometric mean titer ratio of pseudovirus neutralizing antibody titers; 4. Serologic response
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: No, The study is ongoing. Access to patient-level data and supporting clinical documents with qualified external researchers may be available upon request once the trial is complete.
Data accessibility: Not reported, corresponding author: Roderick McPhee, roderick.mcphee@modernatx.com
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the trial registry, protocol, statistical analysis plan and supplementary materials were used in data extraction and assessment of risk of bias. There were no substantive differences between the published article and the trial registry, protocol and statistical analysis plan in population, procedures, interventions or outcomes. The trial achieved its target sample size. The article reports immunogenicity results of an analysis based on noninferiority of neutralizing antibody titers in adolescents compared with young adults, these results were not extracted.