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A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04505722
Recruitment Status : Active, not recruiting
First Posted : August 10, 2020
Results First Posted : April 15, 2022
Last Update Posted : June 8, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
Interventions Biological: Ad26.COV2.S
Other: Placebo
Enrollment 44325
Recruitment Details A total of 44325 participants were randomized, of which 1 participant was randomized in error due to lack of a signed informed consent form. This participant has not been included in the analysis.
Pre-assignment Details Per protocol amendment 6 (04-Sep-2021), booster vaccination was offered at Year 1 to all ongoing participants; data is still under evaluation, so primary outcome measure results of booster phase will be reported in Mar-2024. Participant flow (PF) information below included data from study start date (07-Sep-2020) to data cutoff date (09-Jul-2021), hence 3 deaths reported in AE section but not included in PF as onset date of fatal AEs was before 9jul2021, however participants died after 9jul2021.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level. Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Period Title: Overall Study
Started 22174 22150
Vaccinated 21898 21890
Participants in Entire Double Blind Phase 21894 21882
Completed 0 0
Not Completed 22174 22150
Reason Not Completed
Adverse Event             1             2
Death             34             63
Lost to Follow-up             271             333
Physician Decision             17             17
Protocol Violation             0             1
Withdrawal by Subject             376             714
Other             61             98
Still ongoing             21138             20662
Randomized not vaccinated             276             260
Arm/Group Title Ad26.COV2.S Placebo Total
Hide Arm/Group Description Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level. Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level. Total of all reporting groups
Overall Number of Baseline Participants 21898 21890 43788
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21898 participants 21890 participants 43788 participants
50.7  (15.08) 50.7  (15.04) 50.7  (15.06)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21898 participants 21890 participants 43788 participants
Female
9828
  44.9%
9907
  45.3%
19735
  45.1%
Male
12067
  55.1%
11979
  54.7%
24046
  54.9%
Undifferentiated
2
   0.0%
4
   0.0%
6
   0.0%
Unknown
1
   0.0%
0
   0.0%
1
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21898 participants 21890 participants 43788 participants
American Indian or Alaska Native
2083
   9.5%
2060
   9.4%
4143
   9.5%
Asian
743
   3.4%
686
   3.1%
1429
   3.3%
Native Hawaiian or Other Pacific Islander
56
   0.3%
47
   0.2%
103
   0.2%
Black or African American
4253
  19.4%
4262
  19.5%
8515
  19.4%
White
12858
  58.7%
12843
  58.7%
25701
  58.7%
More than one race
1207
   5.5%
1248
   5.7%
2455
   5.6%
Unknown or Not Reported
698
   3.2%
744
   3.4%
1442
   3.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21898 participants 21890 participants 43788 participants
ARGENTINA
1498
   6.8%
1498
   6.8%
2996
   6.8%
BRAZIL
3644
  16.6%
3635
  16.6%
7279
  16.6%
CHILE
563
   2.6%
570
   2.6%
1133
   2.6%
COLOMBIA
2125
   9.7%
2123
   9.7%
4248
   9.7%
MEXICO
238
   1.1%
241
   1.1%
479
   1.1%
PERU
886
   4.0%
885
   4.0%
1771
   4.0%
SOUTH AFRICA
3287
  15.0%
3289
  15.0%
6576
  15.0%
UNITED STATES
9657
  44.1%
9649
  44.1%
19306
  44.1%
1.Primary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Main Study)
Hide Description Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription-polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute, oxygen saturation (SpO2) <= 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame 14 Days after double-blind vaccination (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Efficacy (PP) set: participants of the FAS (all randomized participants with double-blind study vaccine administration, regardless of protocol deviations and serostatus at enrollment) who received double-blind study vaccine and who were seronegative at the time of vaccination and who had no other major protocol deviations to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19400 19398
Measure Type: Count of Participants
Unit of Measure: Participants
Age: 18-59 years
381
   2.0%
847
   4.4%
Age: Greater than or equal to (>=) 60 years
103
   0.5%
220
   1.1%
2.Primary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status (Main Study)
Hide Description Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >=20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats/minute and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute, SpO2 less than or equal to (<=) 93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the Intensive Care Unit (ICU), death defined as per Food and Drug Administration (FDA) guidance.
Time Frame 28 Days after double-blind vaccination (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the Full Analysis Set (FAS) who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19113 18924
Measure Type: Count of Participants
Unit of Measure: Participants
Age: 18-59 years
340
   1.8%
716
   3.8%
Age: >=60 years
93
   0.5%
167
   0.9%
3.Primary Outcome
Title Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
Hide Description Participants who receive the booster dose was asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days).
Time Frame Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])
Outcome Measure Data Not Reported
4.Primary Outcome
Title Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
Hide Description Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.
Time Frame Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])
Outcome Measure Data Not Reported
5.Primary Outcome
Title Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
Hide Description Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time Frame Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1])
Outcome Measure Data Not Reported
6.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)
Hide Description SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time Frame From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)
Outcome Measure Data Not Reported
7.Primary Outcome
Title Number of Participants With Adverse Events of Special Interest (AESI) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase)
Hide Description Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Time Frame From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months)
Outcome Measure Data Not Reported
8.Primary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Hide Description Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame 14 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 546)
Outcome Measure Data Not Reported
9.Primary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Hide Description Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame 28 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 560)
Outcome Measure Data Not Reported
10.Primary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Hide Description Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame 14 days after booster vaccination (Day 379) to end of study (up to 2 years and 3 month)
Outcome Measure Data Not Reported
11.Primary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase)
Hide Description Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame 28 days after booster vaccination (Day 393) to end of study (up to 2 years and 3 month)
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)
Hide Description Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame 14 Days after double-blind vaccination (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19400 19398
Measure Type: Count of Participants
Unit of Measure: Participants
56
   0.3%
205
   1.1%
13.Secondary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study)
Hide Description Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame 28 Days after double-blind vaccination (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19113 18924
Measure Type: Count of Participants
Unit of Measure: Participants
46
   0.2%
176
   0.9%
14.Secondary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
Hide Description Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame 1 Day after double-blind vaccination (Day 2)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 21898 21890
Measure Type: Count of Participants
Unit of Measure: Participants
575
   2.6%
1189
   5.4%
15.Secondary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
Hide Description Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame 14 days after double-blind vaccination (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine, regardless of their Serostatus at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. This excludes participants who had a COVID-19 case with an onset before day 15.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 21537 21467
Measure Type: Count of Participants
Unit of Measure: Participants
487
   2.3%
1079
   5.0%
16.Secondary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study)
Hide Description Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Time Frame 28 days after double-blind vaccination (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine, regardless of their Serostatus at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. This excludes participants who had a COVID-19 case with an onset before day 29.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 21244 20978
Measure Type: Count of Participants
Unit of Measure: Participants
436
   2.1%
895
   4.3%
17.Secondary Outcome
Title Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)
Hide Description Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation [ECMO], linked to objective measures such as decreased oxygenation, X-ray or computed tomography [CT] findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination were reported.
Time Frame 14 days after double-blind vaccination (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19400 19398
Measure Type: Count of Participants
Unit of Measure: Participants
18
   0.1%
74
   0.4%
18.Secondary Outcome
Title Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study)
Hide Description Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and ECMO, linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination were reported.
Time Frame 28 Days after double-blind vaccination (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19113 18924
Measure Type: Count of Participants
Unit of Measure: Participants
16
   0.1%
64
   0.3%
19.Secondary Outcome
Title SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants With Molecularly Confirmed, Moderate to Severe/Critical COVID-19 (Main Study)
Hide Description The viral load of SARS-CoV-2 was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.
Time Frame 14 Days after double-blind vaccination (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded. Here Number of participants analyzed signifies participants evaluable for this OM.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 483 1041
Mean (Standard Error)
Unit of Measure: Log10 copies*day per milliliter
823.7  (33.668) 921.47  (25.706)
20.Secondary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)
Hide Description Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
Time Frame 14 Days after double-blind vaccination (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19400 19398
Measure Type: Count of Participants
Unit of Measure: Participants
11
   0.1%
15
   0.1%
21.Secondary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study)
Hide Description Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
Time Frame 28 Days after double-blind vaccination (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19113 18924
Measure Type: Count of Participants
Unit of Measure: Participants
10
   0.1%
12
   0.1%
22.Secondary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)
Hide Description Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
Time Frame 14 Days after double-blind vaccination (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19400 19398
Measure Type: Count of Participants
Unit of Measure: Participants
492
   2.5%
1067
   5.5%
23.Secondary Outcome
Title Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study)
Hide Description Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
Time Frame 28 Days after double-blind vaccination (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19113 18924
Measure Type: Count of Participants
Unit of Measure: Participants
441
   2.3%
884
   4.7%
24.Secondary Outcome
Title Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)
Hide Description BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Time Frame 14 Days after double-blind vaccination (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19400 19398
Measure Type: Count of Participants
Unit of Measure: Participants
495
   2.6%
1082
   5.6%
25.Secondary Outcome
Title Number of Participant With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study)
Hide Description BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Time Frame 28 Days after double-blind vaccination (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19113 18924
Measure Type: Count of Participants
Unit of Measure: Participants
443
   2.3%
895
   4.7%
26.Secondary Outcome
Title Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Main Study)
Hide Description Number of participants with SARS-CoV-2 seroconversion based on antibodies to nucleocapsid (N) protein using enzyme-linked immunosorbent assay (ELISA) and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 N protein was reported.
Time Frame From Day 29 until end of double-blind phase (up to 284 days after first vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a COVID-19 case with an onset or discontinued before day 29 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19113 18924
Measure Type: Count of Participants
Unit of Measure: Participants
550
   2.9%
724
   3.8%
27.Secondary Outcome
Title Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Main Study)
Hide Description Number of participants with asymptomatic infection detected by RT-PCR at the time of the Month 6/unblinding visit were reported.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a COVID-19 case with an onset or discontinued before day 29 in PP set were excluded.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19113 18924
Measure Type: Count of Participants
Unit of Measure: Participants
10
   0.1%
12
   0.1%
28.Secondary Outcome
Title Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Main Study)
Hide Description Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) were reported.
Time Frame 28 Days after double-blind vaccination (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Here "N" signifies the excluded participants who had a COVID-19 case with an onset or discontinued before Day 29.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 19113 18924
Measure Type: Count of Participants
Unit of Measure: Participants
1038
   5.4%
1699
   9.0%
29.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) (Main Study)
Hide Description SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time Frame Up to 35 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 21894 21882
Measure Type: Count of Participants
Unit of Measure: Participants
235
   1.1%
358
   1.6%
30.Secondary Outcome
Title Number of Participants With Adverse Events of Special Interest (AESI) (Main Study)
Hide Description Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Time Frame Up to 35 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 21894 21882
Measure Type: Count of Participants
Unit of Measure: Participants
6
   0.0%
5
   0.0%
31.Secondary Outcome
Title Number of Participants With Medically-Attended Adverse Events (MAAEs) (Main Study)
Hide Description MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Time Frame Up to 6 months after double-blind vaccination on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 21894 21882
Measure Type: Count of Participants
Unit of Measure: Participants
1672
   7.6%
1885
   8.6%
32.Secondary Outcome
Title Number of Participants With MAAEs Leading to Study Discontinuation (Main Study)
Hide Description MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases was collected as part of the MAAEs.
Time Frame Up to 35 weeks
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Hide Analysis Population Description
FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 21894 21882
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.0%
2
   0.0%
33.Secondary Outcome
Title Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Main Study)
Hide Description Participants who were enrolled in safety subset were asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time Frame Up to Day 8 (7 Days after double-blind vaccination on Day 1)
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Hide Analysis Population Description
Safety population is a subset of FAS for the analysis of solicited local adverse event. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 3356 3379
Measure Type: Count of Participants
Unit of Measure: Participants
1839
  54.8%
684
  20.2%
34.Secondary Outcome
Title Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Main Study)
Hide Description Participants who were enrolled in safety subset were instructed on how to record daily temperature using a thermometer provided for home use. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Time Frame Up to Day 8 (7 Days after double-blind vaccination on Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is a subset of FAS for the analysis of solicited systemic adverse event. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 3356 3379
Measure Type: Count of Participants
Unit of Measure: Participants
2021
  60.2%
1307
  38.7%
35.Secondary Outcome
Title Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Main Study)
Hide Description Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time Frame Up to Day 29 (28 Days after double-blind vaccination on Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is a subset of FAS for the analysis of unsolicited adverse event. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 3356 3379
Measure Type: Count of Participants
Unit of Measure: Participants
456
  13.6%
422
  12.5%
36.Secondary Outcome
Title Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Main Study)
Hide Description Binding antibodies to SARS-CoV-2 S protein as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response was reported. The lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 50.3 EU/mL and 58,158.10 EU/mL, respectively. A sample was considered positive if the value was strictly greater than the LLOQ (>LLOQ).
Time Frame Baseline (Day 1), Day 29, and Day 71
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Hide Analysis Population Description
PPI set included all randomized and vaccinated participants, including those who were part of the immunogenicity subset and for whom immunogenicity data were available, excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here N (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description:
Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
Overall Number of Participants Analyzed 193 167
Geometric Mean (95% Confidence Interval)
Unit of Measure: ELISA units per milliliter (EU/mL)
Baseline (Day 1) Number Analyzed 193 participants 167 participants
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Day 29 Number Analyzed 177 participants 154 participants
336
(284 to 398)
NA [1] 
(NA to NA)
Day 71 Number Analyzed 164 participants 138 participants
526
(437 to 633)
NA [1] 
(NA to NA)
[1]
Here NA signifies that the sample was not positive as Geometric mean, and 95% confidence interval value were less than LLOQ i.e., 50.3 EU/mL.
Time Frame Up to 35 weeks for DB Phase (SAEs and Other AEs); Up to 41 weeks for open-label plus DB Phase (all-cause mortality)
Adverse Event Reporting Description All-cause mortality and SAEs were monitored in FAS; other (not-including serious) adverse events were monitored in safety population (subset of FAS for solicited and unsolicited AEs analysis) as planned. 'Number of participants at risk' for SAEs are participants in entire double blind (DB) vaccination phase (who received outside vaccination before study start excluded from DB phase). All-cause mortality was reported for DB and open-label phase, while all other safety data reported for DB phase.
 
Arm/Group Title Ad26.COV2.S Placebo
Hide Arm/Group Description Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level. Participants received IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) are offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.
All-Cause Mortality
Ad26.COV2.S Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   36/21898 (0.16%)   64/21890 (0.29%) 
Hide Serious Adverse Events
Ad26.COV2.S Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   235/21894 (1.07%)   358/21882 (1.64%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/21894 (0.01%)  2/21882 (0.01%) 
Blood loss anaemia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Immune thrombocytopenia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Iron deficiency anaemia * 1  1/21894 (0.00%)  3/21882 (0.01%) 
Thrombocytopenia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Cardiac disorders     
Acute coronary syndrome * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Acute myocardial infarction * 1  2/21894 (0.01%)  7/21882 (0.03%) 
Angina pectoris * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Aortic valve stenosis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Arrhythmia * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Arteriosclerosis coronary artery * 1  2/21894 (0.01%)  1/21882 (0.00%) 
Atrial fibrillation * 1  2/21894 (0.01%)  0/21882 (0.00%) 
Atrial flutter * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Cardiac arrest * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Cardiac disorder * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Cardiac failure * 1  2/21894 (0.01%)  4/21882 (0.02%) 
Cardiac failure congestive * 1  2/21894 (0.01%)  4/21882 (0.02%) 
Coronary artery disease * 1  2/21894 (0.01%)  0/21882 (0.00%) 
Coronary artery stenosis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Myocardial infarction * 1  2/21894 (0.01%)  3/21882 (0.01%) 
Myocardial ischaemia * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Pericarditis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Tachycardia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Ventricular tachycardia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Endocrine disorders     
Hyperparathyroidism * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Eye disorders     
Diplopia * 1  1/21894 (0.00%)  2/21882 (0.01%) 
Retinal vein thrombosis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Anal fistula * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Colitis * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Colitis ischaemic * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Colitis ulcerative * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Enteritis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Gallstone ileus * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Gastrointestinal haemorrhage * 1  1/21894 (0.00%)  2/21882 (0.01%) 
Gastrointestinal obstruction * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Gastrooesophageal reflux disease * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Haematemesis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Haemorrhoids * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Hiatus hernia * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Impaired gastric emptying * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Intestinal obstruction * 1  2/21894 (0.01%)  3/21882 (0.01%) 
Large intestine polyp * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Obstructive pancreatitis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Pancreatitis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Pancreatitis acute * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Pancreatolithiasis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Retroperitoneal haemorrhage * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Small intestinal obstruction * 1  1/21894 (0.00%)  3/21882 (0.01%) 
Upper gastrointestinal haemorrhage * 1  1/21894 (0.00%)  2/21882 (0.01%) 
General disorders     
Accidental death * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Chest pain * 1  3/21894 (0.01%)  2/21882 (0.01%) 
Death * 1  7/21894 (0.03%)  4/21882 (0.02%) 
Drowning * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Drug withdrawal syndrome * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Gait disturbance * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Malaise * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Multiple organ dysfunction syndrome * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Oedema peripheral * 1  2/21894 (0.01%)  0/21882 (0.00%) 
Pyrexia * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Sudden death * 1  1/21894 (0.00%)  3/21882 (0.01%) 
Hepatobiliary disorders     
Bile duct stone * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Cholecystitis * 1  3/21894 (0.01%)  1/21882 (0.00%) 
Cholecystitis acute * 1  2/21894 (0.01%)  1/21882 (0.00%) 
Cholecystitis chronic * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Cholelithiasis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Immune system disorders     
Allergy to chemicals * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Hypersensitivity * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Infections and infestations     
Abdominal wall abscess * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Abscess limb * 1  1/21894 (0.00%)  2/21882 (0.01%) 
Acute hepatitis B * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Appendicitis * 1  10/21894 (0.05%)  8/21882 (0.04%) 
Appendicitis perforated * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Bacteraemia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Bacterial infection * 1  0/21894 (0.00%)  1/21882 (0.00%) 
COVID-19 * 1  5/21894 (0.02%)  53/21882 (0.24%) 
COVID-19 pneumonia * 1  9/21894 (0.04%)  45/21882 (0.21%) 
Campylobacter infection * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Cellulitis * 1  2/21894 (0.01%)  2/21882 (0.01%) 
Chronic sinusitis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Clostridium difficile infection * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Complicated appendicitis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Cytomegalovirus infection * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Diarrhoea infectious * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Diverticulitis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Epiglottitis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Epstein-Barr virus infection * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Escherichia infection * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Gangrene * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Gastroenteritis * 1  3/21894 (0.01%)  2/21882 (0.01%) 
Genital abscess * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Implant site infection * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Infection * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Infective exacerbation of chronic obstructive airways disease * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Influenza * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Laryngitis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Liver abscess * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Lower respiratory tract infection * 1  1/21894 (0.00%)  3/21882 (0.01%) 
Lung abscess * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Medical device site infection * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Meningitis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Meningitis cryptococcal * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Neurosyphilis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Osteomyelitis * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Pelvic inflammatory disease * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Periorbital cellulitis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Perirectal abscess * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Peritoneal abscess * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Peritonsillar abscess * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Pilonidal cyst * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Pneumocystis jirovecii pneumonia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Pneumonia * 1  8/21894 (0.04%)  13/21882 (0.06%) 
Pneumonia bacterial * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Pneumonia viral * 1  2/21894 (0.01%)  1/21882 (0.00%) 
Pulmonary tuberculosis * 1  2/21894 (0.01%)  1/21882 (0.00%) 
Pyelonephritis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Respiratory syncytial virus bronchiolitis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Respiratory tract infection * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Scrotal abscess * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Sepsis * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Soft tissue infection * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Staphylococcal bacteraemia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Suspected COVID-19 * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Tonsillitis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Upper respiratory tract infection * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Urinary tract infection * 1  4/21894 (0.02%)  3/21882 (0.01%) 
Urinary tract infection bacterial * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Wound infection * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Anaemia postoperative * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Anastomotic complication * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Anastomotic ulcer haemorrhage * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Ankle fracture * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Craniocerebral injury * 1  2/21894 (0.01%)  2/21882 (0.01%) 
Fall * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Femur fracture * 1  2/21894 (0.01%)  1/21882 (0.00%) 
Foot fracture * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Forearm fracture * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Hand fracture * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Hip fracture * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Incarcerated incisional hernia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Injury * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Jaw fracture * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Ligament injury * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Ligament rupture * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Limb injury * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Lower limb fracture * 1  2/21894 (0.01%)  1/21882 (0.00%) 
Lumbar vertebral fracture * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Multiple fractures * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Multiple injuries * 1  2/21894 (0.01%)  1/21882 (0.00%) 
Muscle rupture * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Nasal injury * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Overdose * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Patella fracture * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Pneumothorax traumatic * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Post procedural haemorrhage * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Post vaccination syndrome * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Post-traumatic pain * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Radius fracture * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Road traffic accident * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Skin laceration * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Soft tissue injury * 1  2/21894 (0.01%)  1/21882 (0.00%) 
Stab wound * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Thermal burn * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Tibia fracture * 1  2/21894 (0.01%)  3/21882 (0.01%) 
Traumatic fracture * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Ulna fracture * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Urinary retention postoperative * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Wound * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Wrist fracture * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Investigations     
HIV test positive * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Haemoglobin decreased * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Pulse absent * 1  0/21894 (0.00%)  1/21882 (0.00%) 
SARS-CoV-2 test positive * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Smear cervix abnormal * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Diabetic ketoacidosis * 1  2/21894 (0.01%)  2/21882 (0.01%) 
Diabetic metabolic decompensation * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Hyperglycaemia * 1  0/21894 (0.00%)  3/21882 (0.01%) 
Metabolic acidosis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Obesity * 1  2/21894 (0.01%)  0/21882 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Back pain * 1  1/21894 (0.00%)  3/21882 (0.01%) 
Intervertebral disc protrusion * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Osteoarthritis * 1  4/21894 (0.02%)  1/21882 (0.00%) 
Pain in extremity * 1  2/21894 (0.01%)  0/21882 (0.00%) 
Rhabdomyolysis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Rotator cuff syndrome * 1  2/21894 (0.01%)  4/21882 (0.02%) 
Spinal osteoarthritis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Adenocarcinoma of colon * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Basal cell carcinoma * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Bladder cancer * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Brain cancer metastatic * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Breast cancer * 1  3/21894 (0.01%)  4/21882 (0.02%) 
Breast cancer metastatic * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Breast neoplasm * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Cancer pain * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Chronic myeloid leukaemia * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Colon cancer * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Ductal adenocarcinoma of pancreas * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Endometrial adenocarcinoma * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Endometrial cancer * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Gastric cancer * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Glioblastoma * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Intraductal proliferative breast lesion * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Intraosseous meningioma * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Invasive ductal breast carcinoma * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Lung adenocarcinoma * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Lung neoplasm malignant * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Malignant melanoma * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Metastases to liver * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Neoplasm of orbit * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Neuroendocrine tumour * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Oesophageal carcinoma * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Ovarian cancer * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Pancreatic neoplasm * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Pituitary tumour benign * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Prostate cancer * 1  2/21894 (0.01%)  1/21882 (0.00%) 
Skin papilloma * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Thymoma * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Thyroid cancer * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Uterine cancer * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Uterine leiomyoma * 1  1/21894 (0.00%)  4/21882 (0.02%) 
Nervous system disorders     
Bell's palsy * 1  2/21894 (0.01%)  0/21882 (0.00%) 
Brain stem stroke * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Carotid artery occlusion * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Carotid artery stenosis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Cerebral haemorrhage * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Cerebral infarction * 1  1/21894 (0.00%)  2/21882 (0.01%) 
Cerebral venous sinus thrombosis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Cerebrovascular accident * 1  3/21894 (0.01%)  6/21882 (0.03%) 
Cervical radiculopathy * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Complex regional pain syndrome * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Dizziness * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Epilepsy * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Guillain-Barre syndrome * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Hemiparesis * 1  2/21894 (0.01%)  0/21882 (0.00%) 
Hemiplegia * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Hydrocephalus * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Hypertensive encephalopathy * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Intracranial aneurysm * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Intracranial mass * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Ischaemic stroke * 1  3/21894 (0.01%)  0/21882 (0.00%) 
Metabolic encephalopathy * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Migraine * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Optic neuritis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Paraparesis * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Seizure * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Spinal cord compression * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Spinal cord haematoma * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Subarachnoid haemorrhage * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Syncope * 1  2/21894 (0.01%)  2/21882 (0.01%) 
Transient global amnesia * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Transient ischaemic attack * 1  1/21894 (0.00%)  3/21882 (0.01%) 
Transverse sinus thrombosis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Uraemic encephalopathy * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion incomplete * 1  1/21894 (0.00%)  2/21882 (0.01%) 
Abortion spontaneous * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Ectopic pregnancy * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Foetal growth abnormality * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Psychiatric disorders     
Aggression * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Anxiety * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Catatonia * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Completed suicide * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Depression * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Major depression * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Mental status changes * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Substance dependence * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Suicidal ideation * 1  2/21894 (0.01%)  4/21882 (0.02%) 
Suicide attempt * 1  1/21894 (0.00%)  4/21882 (0.02%) 
Renal and urinary disorders     
Acute kidney injury * 1  2/21894 (0.01%)  2/21882 (0.01%) 
Bladder trabeculation * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Chronic kidney disease * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Haematuria * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Hydronephrosis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Nephrolithiasis * 1  3/21894 (0.01%)  2/21882 (0.01%) 
Renal colic * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Renal failure * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Renal haematoma * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Renal injury * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Renal mass * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Ureterolithiasis * 1  2/21894 (0.01%)  1/21882 (0.00%) 
Reproductive system and breast disorders     
Abnormal uterine bleeding * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Benign prostatic hyperplasia * 1  1/21894 (0.00%)  1/21882 (0.00%) 
Breast mass * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Heavy menstrual bleeding * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Ovarian hyperstimulation syndrome * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Prostatitis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Prostatomegaly * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Testicular torsion * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Vaginal haemorrhage * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  4/21894 (0.02%)  2/21882 (0.01%) 
Chronic obstructive pulmonary disease * 1  2/21894 (0.01%)  2/21882 (0.01%) 
Dyspnoea * 1  2/21894 (0.01%)  0/21882 (0.00%) 
Hypoxia * 1  2/21894 (0.01%)  0/21882 (0.00%) 
Pleural effusion * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Pleural mass * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Pneumonia aspiration * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Pneumothorax * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Pneumothorax spontaneous * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Pulmonary embolism * 1  9/21894 (0.04%)  3/21882 (0.01%) 
Pulmonary hypertension * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Pulmonary oedema * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Respiratory distress * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Respiratory failure * 1  0/21894 (0.00%)  2/21882 (0.01%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Urticaria * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Social circumstances     
Physical assault * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Vascular disorders     
Thrombophlebitis of the right upper limb cephalic vein * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Aortic stenosis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Deep vein thrombosis * 1  4/21894 (0.02%)  2/21882 (0.01%) 
Embolism venous * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Haematoma * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Hypertension * 1  2/21894 (0.01%)  2/21882 (0.01%) 
Hypertensive crisis * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Hypertensive urgency * 1  1/21894 (0.00%)  0/21882 (0.00%) 
Hypotension * 1  0/21894 (0.00%)  1/21882 (0.00%) 
Varicose vein * 1  0/21894 (0.00%)  1/21882 (0.00%) 
1
Term from vocabulary, MedDRA Version 24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Ad26.COV2.S Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   151/3356 (4.50%)   124/3380 (3.67%) 
General disorders     
Chills * 1  70/3356 (2.09%)  22/3380 (0.65%) 
Fatigue * 1  48/3356 (1.43%)  70/3380 (2.07%) 
Nervous system disorders     
Headache * 1  63/3356 (1.88%)  70/3380 (2.07%) 
1
Term from vocabulary, MedDRA Version 24.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: SENIOR ADVISOR CLINICAL DEVELOPMENT
Organization: Janssen R&D US
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT04505722    
Other Study ID Numbers: CR108876
VAC31518COV3001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Submitted: July 31, 2020
First Posted: August 10, 2020
Results First Submitted: January 25, 2022
Results First Posted: April 15, 2022
Last Update Posted: June 8, 2022