Trial NCT04368988
Publication Formica N, PLoS Med, 2021
Dates: 2020-08-24 to 2020-09-25
Funding: Mixed (Coalition for Epidemic Preparedness Innovations; Novavax Inc)
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / Australia, USA
Follow-up duration (months): 1.15
• Placebo (n = 257)
• NVX-CoV2373 5mcg 2 doses (n = 258
• NVX-CoV2373 5mcg 1 dose (n = 257
• NVX-CoV2373 25mcg 2 doses (n = 258
• NVX-CoV2373 25mcg 1 dose (n = 258
Inclusion criteria
  • Men and non-pregnant women 18 to 84 years of age
  • body mass index of 17 to 35
  • participants with underlying medical conditions could be enrolled if the conditions were judged clinically to be stable.
Exclusion criteriaNR
Interventions
Intervention
2 IM doses 5-mcg on days 0, 21
1 IM dose 5-mcg day 0, 1 IM dose placebo day 21
2 IM doses 25-mcg on days 0, 21
1 IM dose 25-mcg day 0, 1 IM dose placebo day 21
Control
2 IM doses placebo on days 0, 21
Participants
Randomized
1288 participants
Characteristics of participants
Type of participants: Adults
N=1288
630 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Healthy adults (stable comorbidities permitted) aged 18-84 years at 17 centers in Australia and USA
Primary outcome
In the register
Serum IgG Antibody Levels Expressed as GMTs (day 35); Serum IgG Antibody Levels Expressed as GMFRs (day 35); Serum IgG Antibody Levels Expressed as SCRs (day 35); Participants with Solicited Adverse Events (AEs) (28 days); Participants with Unsolicited AEs (35 days)
In the report
Primary endpoints were immunoglobulin G (IgG) anti-spike protein response, 7-day solicited reactogenicity, and unsolicited adverse events.
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: NR,
Data accessibility: NR
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 was used in data extraction and assessment of risk of bias. Protocol and statistical analysis plan were not available at the time of data collection. There were no substantive differences between the article and the registry in population, procedures, interventions or outcomes. This is a preliminary analysis of outcomes in a study in which follow up is ongoing. The study achieved its pre-stated sample size.
This trial was updated on October 11th 2021, after publication of the study report.