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

• ClinicalTrials.gov Identifier: NCT04505722
• Recruitment Status: Completed
• First Posted: August 10, 2020
• Results First Posted: April 15, 2022
• Last Update Posted: May 6, 2023
• Sponsor: Janssen Vaccines & Prevention B.V.
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Ad26.COV2.S	Placebo	Total
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
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%

Outcome Measures

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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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.

Adverse Events

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
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• 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):

Sadoff J, Gray G, Vandebosch A, Cardenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Van Dromme I, Spiessens B, Vingerhoets J, Custers J, Scheper G, Robb ML, Treanor J, Ryser MF, Barouch DH, Swann E, Marovich MA, Neuzil KM, Corey L, Stoddard J, Hardt K, Ruiz-Guinazu J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S. N Engl J Med. 2022 Mar 3;386(9):847-860. doi: 10.1056/NEJMoa2117608. Epub 2022 Feb 9.

Sadoff J, Struyf F, Douoguih M. A plain language summary of how well the single-dose Janssen vaccine works and how safe it is. Future Virol. 2021 Nov;16(11):725-739. doi: 10.2217/fvl-2021-0199. Epub 2021 Nov 1.

Sadoff J, Gray G, Vandebosch A, Cardenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Fennema H, Spiessens B, Offergeld K, Scheper G, Taylor KL, Robb ML, Treanor J, Barouch DH, Stoddard J, Ryser MF, Marovich MA, Neuzil KM, Corey L, Cauwenberghs N, Tanner T, Hardt K, Ruiz-Guinazu J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. 2021 Jun 10;384(23):2187-2201. doi: 10.1056/NEJMoa2101544. Epub 2021 Apr 21.

Williams TC, Burgers WA. SARS-CoV-2 evolution and vaccines: cause for concern? Lancet Respir Med. 2021 Apr;9(4):333-335. doi: 10.1016/S2213-2600(21)00075-8. Epub 2021 Jan 29. No abstract available.

• 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: May 6, 2023