Trial Outcomes & Findings for The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection (NCT NCT06065176)
NCT ID: NCT06065176
Last Updated: 2026-01-28
Results Overview
Difference in the number of symptomatic SARS-CoV-2 infections between randomized, study-vaccinated participants and the comparator group who did not receive an updated COVID-19 vaccine (2023-2024 formula).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1188 participants
Primary outcome timeframe
24 weeks after enrollment
Results posted on
2026-01-28
Participant Flow
The BEEHIVE trial enrolled and monitored participants from 22 November 2023 through 9 September 2024. 5590 participants were screened.
1188 total participants enrolled.
Participant milestones
| Measure |
Novavax COVID-19 Booster
452 participants received a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
|
Pfizer COVID-19 Booster
457 participants received a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
|
Non-boosted Comparison Group
279 participants did not receive a dose of the study vaccine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
452
|
457
|
279
|
|
Overall Study
COMPLETED
|
437
|
440
|
266
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
13
|
Reasons for withdrawal
| Measure |
Novavax COVID-19 Booster
452 participants received a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
|
Pfizer COVID-19 Booster
457 participants received a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
|
Non-boosted Comparison Group
279 participants did not receive a dose of the study vaccine.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
11
|
10
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
|
Overall Study
No longer met eligibility requirements to continue participation.
|
3
|
5
|
1
|
Baseline Characteristics
The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection
Baseline characteristics by cohort
| Measure |
Novavax COVID-19 Booster
n=452 Participants
452 participants received a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
|
Pfizer COVID-19 Booster
n=457 Participants
457 participants received a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
|
Non-boosted Comparison Group
n=279 Participants
279 participants did not receive a dose of the study vaccine.
|
Total
n=1188 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
10 Participants
n=72 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
409 Participants
n=41 Participants
|
406 Participants
n=1581 Participants
|
246 Participants
n=4626 Participants
|
1061 Participants
n=72 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=41 Participants
|
46 Participants
n=1581 Participants
|
31 Participants
n=4626 Participants
|
117 Participants
n=72 Participants
|
|
Sex/Gender, Customized
Sex Assigned at Birth · Female
|
248 Participants
n=41 Participants
|
250 Participants
n=1581 Participants
|
147 Participants
n=4626 Participants
|
645 Participants
n=72 Participants
|
|
Sex/Gender, Customized
Sex Assigned at Birth · Male
|
203 Participants
n=41 Participants
|
206 Participants
n=1581 Participants
|
132 Participants
n=4626 Participants
|
541 Participants
n=72 Participants
|
|
Sex/Gender, Customized
Sex Assigned at Birth · Prefer Not to Answer
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
7 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=41 Participants
|
23 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
51 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
13 Participants
n=72 Participants
|
|
Race (NIH/OMB)
White
|
393 Participants
n=41 Participants
|
394 Participants
n=1581 Participants
|
241 Participants
n=4626 Participants
|
1028 Participants
n=72 Participants
|
|
Race (NIH/OMB)
More than one race
|
34 Participants
n=41 Participants
|
25 Participants
n=1581 Participants
|
16 Participants
n=4626 Participants
|
75 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
13 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=41 Participants
|
49 Participants
n=1581 Participants
|
25 Participants
n=4626 Participants
|
128 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
398 Participants
n=41 Participants
|
408 Participants
n=1581 Participants
|
254 Participants
n=4626 Participants
|
1060 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after enrollmentPopulation: mITT population. Combining both vaccinated arms in a single group most appropriately represents the study's primary objective. The two vaccinated arms are assessed relative to each other in the study's secondary objective.
Difference in the number of symptomatic SARS-CoV-2 infections between randomized, study-vaccinated participants and the comparator group who did not receive an updated COVID-19 vaccine (2023-2024 formula).
Outcome measures
| Measure |
Non-Booster Comparator Group
n=278 Participants
279 participants who consented to enrollment but declined receipt of a study vaccine dose.
|
Randomized Group
n=898 Participants
909 were randomized into the protein subunit (N=452) and mRNA (N=457) groups.
Randomized participants received a single intramuscular dose of either study vaccine (0.3 mL for mRNA and 0.5 mL for protein subunit) in the deltoid.
|
|---|---|---|
|
Number of Symptomatic SARS-CoV-2 Infections Between Randomized, Study-vaccinated Participants and the Comparator Group
|
48 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: 24 weeks after study enrollmentPopulation: mITT population
Difference in the number of symptomatic SARS-CoV-2 infections between the protein subunit and mRNA vaccine groups.
Outcome measures
| Measure |
Non-Booster Comparator Group
n=444 Participants
279 participants who consented to enrollment but declined receipt of a study vaccine dose.
|
Randomized Group
n=454 Participants
909 were randomized into the protein subunit (N=452) and mRNA (N=457) groups.
Randomized participants received a single intramuscular dose of either study vaccine (0.3 mL for mRNA and 0.5 mL for protein subunit) in the deltoid.
|
|---|---|---|
|
Number of Symptomatic SARS-CoV-2 Infections Between the Protein Subunit and mRNA Vaccine Groups.
|
52 Participants
|
42 Participants
|
Adverse Events
Novavax COVID-19 Booster
Serious events: 1 serious events
Other events: 401 other events
Deaths: 0 deaths
Pfizer COVID-19 Booster
Serious events: 5 serious events
Other events: 436 other events
Deaths: 0 deaths
Non-boosted Comparison Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Novavax COVID-19 Booster
n=452 participants at risk
452 participants received a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
|
Pfizer COVID-19 Booster
n=457 participants at risk
457 participants received a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
|
Non-boosted Comparison Group
n=279 participants at risk
279 participants did not receive a dose of the study vaccine.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Serious injuries due to auto accident
|
0.00%
0/452 • From enrollment until the end of follow-up, up to 24 weeks
|
0.22%
1/457 • Number of events 1 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Infections and infestations
Infections due to complications of surgery
|
0.00%
0/452 • From enrollment until the end of follow-up, up to 24 weeks
|
0.44%
2/457 • Number of events 3 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Psychiatric disorders
Hospitalization due to mental health crisis
|
0.00%
0/452 • From enrollment until the end of follow-up, up to 24 weeks
|
0.22%
1/457 • Number of events 3 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Emergency Cesarean Section due to premature labor
|
0.22%
1/452 • Number of events 1 • From enrollment until the end of follow-up, up to 24 weeks
|
0.22%
1/457 • Number of events 1 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
Other adverse events
| Measure |
Novavax COVID-19 Booster
n=452 participants at risk
452 participants received a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
|
Pfizer COVID-19 Booster
n=457 participants at risk
457 participants received a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2023-2024 formula (XBB containing) in the deltoid muscle of the arm.
|
Non-boosted Comparison Group
n=279 participants at risk
279 participants did not receive a dose of the study vaccine.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Injection Site Pain
|
61.3%
277/452 • Number of events 277 • From enrollment until the end of follow-up, up to 24 weeks
|
83.6%
382/457 • Number of events 382 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Injection Site Swelling
|
11.3%
51/452 • Number of events 51 • From enrollment until the end of follow-up, up to 24 weeks
|
24.7%
113/457 • Number of events 113 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Injection Site Tenderness
|
74.6%
337/452 • Number of events 337 • From enrollment until the end of follow-up, up to 24 weeks
|
88.6%
405/457 • Number of events 405 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
32.3%
146/452 • Number of events 146 • From enrollment until the end of follow-up, up to 24 weeks
|
52.5%
240/457 • Number of events 240 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Immune system disorders
Fatigue
|
38.7%
175/452 • Number of events 175 • From enrollment until the end of follow-up, up to 24 weeks
|
54.9%
251/457 • Number of events 251 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Immune system disorders
Fever
|
2.9%
13/452 • Number of events 13 • From enrollment until the end of follow-up, up to 24 weeks
|
8.8%
40/457 • Number of events 40 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Immune system disorders
Joint Pain
|
10.6%
48/452 • Number of events 48 • From enrollment until the end of follow-up, up to 24 weeks
|
20.8%
95/457 • Number of events 95 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Immune system disorders
Malaise
|
18.6%
84/452 • Number of events 84 • From enrollment until the end of follow-up, up to 24 weeks
|
38.7%
177/457 • Number of events 177 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Immune system disorders
Nausea
|
5.8%
26/452 • Number of events 35 • From enrollment until the end of follow-up, up to 24 weeks
|
9.2%
42/457 • Number of events 55 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
|
Immune system disorders
Headache
|
26.8%
121/452 • Number of events 121 • From enrollment until the end of follow-up, up to 24 weeks
|
36.8%
168/457 • Number of events 168 • From enrollment until the end of follow-up, up to 24 weeks
|
0.00%
0/279 • From enrollment until the end of follow-up, up to 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place