A Phase 3 interventional study of Ad26.COV2.S and Placebo in Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 225 sites in 8 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Janssen Vaccines & Prevention B.V. · Phase 3, Interventional, and Prevention
The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 44,325 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Janssen Vaccines & Prevention B.V. is the lead sponsor of 48 studies on the registry; none are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 32 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive 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 coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5\*10\^10 vp dose level.
Biological: Ad26.COV2.S
Participants will receive 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 will be offered to receive 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 vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5\*10\^10 vp dose level.
Biological: Ad26.COV2.S · Other: Placebo
Ad26.COV2.S will be administered at a single dose of 5\*10\^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.
Also known as: JNJ-78436735, Ad26COVS1
Participants will receive Placebo.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase
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: From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase
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: From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6
Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
Participants who received the booster dose 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-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])
Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
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])
Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase)
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])
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase
Molecularly confirmed 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. Seronegative is defined as N-serology seronegative at the time of boosting or at the Year 1 visit if not boosted.
Time frame: From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase
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: From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)
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 on Day 1 (Day 2)
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)
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 on Day 1 (Day 15)
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)
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 on Day 1 (Day 29)
Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase)
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 on Day 1 (Day 15)
Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase)
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 on Day 1 (Day 29)
Area Under the Curve (AUC) of 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 (Double Blind Phase)
AUC of SARS-CoV-2 Viral Load was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.
Time frame: From Day 15 to end of the COVID-19 episode (Day 189)
Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase
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 on Day1 (Day 15)
Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase)
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 on Day 1 (Day 29)
Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Double Blind Phase)
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 on Day 1 (Day 15)
Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Double Blind Phase)
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 on Day 1 (Day 29)
Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase)
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 on Day 1 (Day 15)
Number of Participants With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase)
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 on Day 1 (Day 29)
Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Double Blind Phase)
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 at Month 6
Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Double Blind Phase)
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
Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Double Blind Phase)
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 on Day 1 (Day 29)
Number of Participants With First Occurrence of Molecularly Confirmed, Moderate to Severe/Critical COVID-19 for Seronegative Participants (Double Blind Phase)
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. Seronegative is defined as N-serology seronegative at the time of boosting or at the Year 1 visit if not boosted.
Time frame: 1 day after double-blind vaccination on Day 1 (Day 2)
Number of Participants With Serious Adverse Events (SAEs) (Double Blind Phase)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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: Baseline (Day 1) up to 35 weeks
Number of Participants With Adverse Events of Special Interest (AESI) (Double Blind Phase)
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: Baseline (Day 1) up to 35 weeks
Number of Participants With Medically-Attended Adverse Events (MAAEs) (Double Blind Phase)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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 (up to 6 months)
Number of Participants With MAAEs Leading to Study Discontinuation (Double Blind Phase)
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
Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Double Blind Phase)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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)
Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Double Blind Phase)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with pharmaceutical/biological agent under study. 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)
Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Double Blind Phase)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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)
Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Double Blind Phase)
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
Number of Participants With Antibody Titers to Ad26.COV2.S (Booster Phase)
Number of participants with antibody titers to Ad26.COV2.S to measure immune response were reported.
Time frame: 28 days after booster vaccination on Day 365 (up to Day 393)
Number of Participants With Binding Antibodies to SARS- CoV-2S Protein as Measured by ELISA (Booster Phase)
Number of participants with binding antibodies to SARS- CoV-2S protein as measured by ELISA was reported.
Time frame: 29 days after booster vaccination on Day 365 (Day 394)
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.
| Milestone | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo | Combined Double-blind and Open-label Phase: All Participants |
|---|---|---|---|
| Started | 22174 | 22150 | 0 |
| Vaccinated | 21898 | 21890 | 0 |
| Completed | 21138 | 20662 | 0 |
| Not completed | 1036 | 1488 | 0 |
| Withdrew: Adverse event | 1 | 2 | 0 |
| Withdrew: Death | 34 | 63 | 0 |
| Withdrew: Lost to follow-up | 271 | 333 | 0 |
| Withdrew: Physician decision | 17 | 17 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 376 | 714 | 0 |
| Withdrew: Other | 61 | 98 | 0 |
| Withdrew: Randomized not vaccinated | 276 | 260 | 0 |
| Milestone | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo | Combined Double-blind and Open-label Phase: All Participants |
|---|---|---|---|
| Started | 0 | 0 | 43788 |
| Completed | 0 | 0 | 31593 |
| Not completed | 0 | 0 | 12195 |
| Withdrew: Adverse event | 0 | 0 | 6 |
| Withdrew: Death | 0 | 0 | 324 |
| Withdrew: Lost to follow-up | 0 | 0 | 4978 |
| Withdrew: Physician decision | 0 | 0 | 342 |
| Withdrew: Protocol violation | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 4332 |
| Withdrew: Other | 0 | 0 | 2211 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Age: 18-59 years | 381 | 847 |
| Age: Greater than or equal to (>=) 60 years | 103 | 220 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Age: 18-59 years | 340 | 716 |
| Age: >=60 years | 93 | 167 |
| All participants | 433 | 883 |
Participants who received the booster dose 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-booster vaccination (day of vaccination and the subsequent 7 days).
| Participants | OL Phase: Ad26.COV2.S 5*10^10 vp + Ad26.COV2.S 5*10^10 vp Booster | Open Label Phase: mRNA 2 Dose Schedule + Ad26.COV2.S 5*10^10 vp Booster | OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster |
|---|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase) | 3758 | 135 | 204 |
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.
| Participants | OL Phase: Ad26.COV2.S 5*10^10 vp + Ad26.COV2.S 5*10^10 vp Booster | Open Label Phase: mRNA 2 Dose Schedule + Ad26.COV2.S 5*10^10 vp Booster | OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster |
|---|---|---|---|
| Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase) | 3559 | 145 | 198 |
Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
| Participants | OL Phase: Ad26.COV2.S 5*10^10 vp + Ad26.COV2.S 5*10^10 vp Booster | Open Label Phase: mRNA 2 Dose Schedule + Ad26.COV2.S 5*10^10 vp Booster | OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster |
|---|---|---|---|
| Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase) | 2133 | 58 | 95 |
Molecularly confirmed 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. Seronegative is defined as N-serology seronegative at the time of boosting or at the Year 1 visit if not boosted.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase | 56 | 205 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase | 46 | 176 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase) | 575 | 1189 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase) | 487 | 1079 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase) | 436 | 895 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase) | 18 | 74 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase) | 16 | 64 |
AUC of SARS-CoV-2 Viral Load was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.
| Log10 copies*day per milliliter | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Area Under the Curve (AUC) of 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 (Double Blind Phase) | 823.7 ± 33.668 | 921.47 ± 25.706 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase | 11 | 15 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase) | 10 | 12 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Double Blind Phase) | 492 | 1067 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Double Blind Phase) | 441 | 884 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase) | 495 | 1082 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase) | 443 | 895 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Double Blind Phase) | 550 | 724 |
Number of participants with asymptomatic infection detected by RT-PCR at the time of the Month 6/unblinding visit were reported.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Double Blind Phase) | 10 | 12 |
Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) were reported.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Double Blind Phase) | 1038 | 1699 |
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. Seronegative is defined as N-serology seronegative at the time of boosting or at the Year 1 visit if not boosted.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With First Occurrence of Molecularly Confirmed, Moderate to Severe/Critical COVID-19 for Seronegative Participants (Double Blind Phase) | 575 | 1189 |
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) (Double Blind Phase) | 235 | 358 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With Adverse Events of Special Interest (AESI) (Double Blind Phase) | 6 | 5 |
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With Medically-Attended Adverse Events (MAAEs) (Double Blind Phase) | 1672 | 1885 |
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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With MAAEs Leading to Study Discontinuation (Double Blind Phase) | 1 | 2 |
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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).
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Double Blind Phase) | 1839 | 684 |
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with pharmaceutical/biological agent under study. 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.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Double Blind Phase) | 2021 | 1307 |
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
| Participants | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Double Blind Phase) | 456 | 422 |
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).
| ELISA units per milliliter (EU/mL) | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo |
|---|---|---|
| Baseline (Day 1) | NA (NA to NA) | NA (NA to NA) |
| Day 29 | 336 (284 to 398) | NA (NA to NA) |
| Day 71 | 526 (437 to 633) | NA (NA to NA) |
Number of participants with antibody titers to Ad26.COV2.S to measure immune response were reported.
No measurements were reported for this outcome.
Number of participants with binding antibodies to SARS- CoV-2S protein as measured by ELISA was reported.
| Participants | Homologous Booster Group (2 Doses of Ad26.COV2.S 5*10^10 vp) | Heterologous Booster Group: Placebo + 2 Doses of mRNA Vaccine + Ad26.COV2.S 5*10^10 vp | Heterologous Booster Group: Ad26.COV2.S 5*10^10 vp Booster After Any Other Schedule | Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp |
|---|---|---|---|---|
| Number of Participants With Binding Antibodies to SARS- CoV-2S Protein as Measured by ELISA (Booster Phase) | 64 | 26 | 9 | 3 |
Collected over DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Double-blind Phase: Ad26.COV2.S 5*10^10 vp | 36/21,898 (0.2%) | 235/21,898 (1.1%) | 2,451/3,356 (73%) |
| Double-blind Phase: Placebo | 64/21,890 (0.3%) | 358/21,890 (1.6%) | 1,653/3,380 (48.9%) |
| Combined Double-blind and Open-label Phase: All Participants | 324/43,788 (0.7%) | 2,758/43,788 (6.3%) | — |
| OL Phase: Ad26.COV2.S 5*10^10 vp + Ad26.COV2.S 5*10^10 vp Booster | — | — | 6,048/22,213 (27.2%) |
| Open Label Phase: mRNA 2 Dose Schedule + Ad26.COV2.S 5*10^10 vp Booster | — | — | 190/613 (31%) |
| OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster | — | — | 315/943 (33.4%) |
| Event | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo | Combined Double-blind and Open-label Phase: All Participants | OL Phase: Ad26.COV2.S 5*10^10 vp + Ad26.COV2.S 5*10^10 vp Booster | Open Label Phase: mRNA 2 Dose Schedule + Ad26.COV2.S 5*10^10 vp Booster | OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster |
|---|---|---|---|---|---|---|
| COVID-19Infections and infestations | 5/21898 | 53/21890 | 146/43788 | — | — | — |
| COVID-19 pneumoniaInfections and infestations | 9/21898 | 45/21890 | 105/43788 | — | — | — |
| DeathGeneral disorders | 7/21898 | 4/21890 | 59/43788 | — | — | — |
| PneumoniaInfections and infestations | 8/21898 | 13/21890 | 56/43788 | — | — | — |
| AppendicitisInfections and infestations | 10/21898 | 8/21890 | 54/43788 | — | — | — |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 4/21898 | 1/21890 | 54/43788 | — | — | — |
| Acute myocardial infarctionCardiac disorders | 2/21898 | 7/21890 | 53/43788 | — | — | — |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 9/21898 | 3/21890 | 50/43788 | — | — | — |
| Atrial fibrillationCardiac disorders | 2/21898 | 0/21890 | 47/43788 | — | — | — |
| Ischaemic strokeNervous system disorders | 3/21898 | 0/21890 | 45/43788 | — | — | — |
| Event | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo | Combined Double-blind and Open-label Phase: All Participants | OL Phase: Ad26.COV2.S 5*10^10 vp + Ad26.COV2.S 5*10^10 vp Booster | Open Label Phase: mRNA 2 Dose Schedule + Ad26.COV2.S 5*10^10 vp Booster | OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster |
|---|---|---|---|---|---|---|
| Vaccination site pain(Solicited)General disorders | 1781/3356 | 595/3380 | — | 3702/22213 | 134/613 | 201/943 |
| Headache (Solicited)Nervous system disorders | 1454/3356 | 900/3380 | — | 2220/22213 | 97/613 | 130/943 |
| Fatigue(Solicited)General disorders | 1420/3356 | 829/3380 | — | 2589/22213 | 115/613 | 155/943 |
| Myalgia(Solicited)Musculoskeletal and connective tissue disorders | 1246/3356 | 494/3380 | — | 2140/22213 | 105/613 | 126/943 |
| Nausea(Solicited)Gastrointestinal disorders | 550/3356 | 363/3380 | — | 968/22213 | 35/613 | 67/943 |
| Pyrexia(Solicited)General disorders | 250/3356 | 12/3380 | — | 169/22213 | 20/613 | 16/943 |
| Vaccination site erythema (Solicited)General disorders | 246/3356 | 134/3380 | — | 325/22213 | 12/613 | 27/943 |
| Vaccination site swelling(Solicited)General disorders | 198/3356 | 51/3380 | — | 316/22213 | 11/613 | 21/943 |
| FatigueGeneral disorders | 48/3356 | 70/3380 | — | 153/22213 | 5/613 | 21/943 |
| ChillsGeneral disorders | 70/3356 | 22/3380 | — | 20/22213 | 3/613 | 3/943 |
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(years) | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo | Total |
|---|---|---|---|
| Mean | 50.7 ± 15.08 | 50.7 ± 15.04 | 50.7 ± 15.06 |
| Sex/Gender, Customized(Participants) | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo | Total |
|---|---|---|---|
| Female | 9828 | 9907 | 19735 |
| Male | 12067 | 11979 | 24046 |
| Undifferentiated | 2 | 4 | 6 |
| Unknown | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 9875 | 9964 | 19839 |
| Not Hispanic or Latino | 11476 | 11367 | 22843 |
| Unknown or Not Reported | 547 | 559 | 1106 |
| Race (NIH/OMB)(Participants) | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2083 | 2060 | 4143 |
| Asian | 743 | 686 | 1429 |
| Native Hawaiian or Other Pacific Islander | 56 | 47 | 103 |
| Black or African American | 4253 | 4262 | 8515 |
| White | 12858 | 12843 | 25701 |
| More than one race | 1207 | 1248 | 2455 |
| Unknown or Not Reported | 698 | 744 | 1442 |
| Region of Enrollment(participants) | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Double-blind Phase: Placebo | Total |
|---|---|---|---|
| ARGENTINA | 1498 | 1498 | 2996 |
| BRAZIL | 3644 | 3635 | 7279 |
| CHILE | 563 | 570 | 1133 |
| COLOMBIA | 2125 | 2123 | 4248 |
| MEXICO | 238 | 241 | 479 |
| PERU | 886 | 885 | 1771 |
| SOUTH AFRICA | 3287 | 3289 | 6576 |
| UNITED STATES | 9657 | 9649 | 19306 |
Showing the first 100 of 225 sites across 8 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen Vaccines & Prevention B.V.