CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,188 enrolled
Drug / intervention
Novavax COVID-19 vaccine (2023-2024 formula XBB containing) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06065176
NCT06065176Phase 4Completed

Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy Study: Randomized Trial to Compare the Clinical Efficacy of Novavax vs. mRNA COVID-19 2023-2024 Updated Vaccines Among Adults in the United States

Sarang K. Yoon, DO, MOH·interventional·Posted Oct 3, 2023·Updated Jan 28, 2026

In Brief

A Phase 4 clinical trial evaluating Novavax COVID-19 vaccine (2023-2024 formula XBB containing) and Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing) for COVID-19 and 4 related conditions. Completed, enrolled 1,188 participants across 1 site.

Detailed Summary

The purpose of this research study is to find out how well two different 2023-2024 updated COVID-19 vaccines protect people from COVID-19 (the disease caused by the SARS-CoV-2 virus), and to determine if getting a 2023-2024 updated vaccine provides better protection from COVID-19 than not getting a vaccine. If the participant chooses to get a 2023-2024 updated COVID-19 vaccine as part of this study, they will have a 50/50 chance of receiving either the Novavax or Pfizer mRNA vaccine. If the participant decides not to get a 2023-2024 updated COVID-19 vaccine, the participant can still participate in other study activities. STUDY ACTIVITIES: * An online enrollment survey * An in-person enrollment visit * Weekly online surveys for 20 weeks * Weekly COVID-19 tests for 20 weeks * Additional online surveys if you have COVID-19 symptoms or tested positive for COVID-19. * Additional COVID-19 tests if you have COVID-19 symptoms or tested positive. * Online survey questions in the middle and at the end of the study

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsWestat, Novavax

Timeline

Phase 4CompletedFinished
202420252026
First PostedOct 3, 2023
Enrollment StartNov 22, 2023
Primary CompletionSep 2, 2024
Study CompletionSep 9, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.7 years ago

Interventions

Novavax COVID-19 vaccine (2023-2024 formula XBB containing)biological

Participants will receive a single dose of the Novavax vaccine.

Pfizer COVID-19 mRNA vaccine (2023-2024 formula XBB containing)biological

Participants will receive a single dose of the Pfizer vaccine.