Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol Clinical Trial
— ENSEMBLEOfficial title:
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
| Verified date | May 2024 |
| Source | Janssen Vaccines & Prevention B.V. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 44325 |
| Est. completion date | March 31, 2023 |
| Est. primary completion date | March 31, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies - All participants of childbearing potential must: have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration - Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine - Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study - Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 [COVID 19] signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Note: Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the electronic clinical outcome assessment (eCOA) questionnaires Exclusion Criteria: - Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor - Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine ; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine - Participant previously received a coronavirus vaccine - Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) within 30 days or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | CEMEDIC | Buenos Aires | |
| Argentina | CIPREC | Buenos Aires | |
| Argentina | Helios Salud Sa | Buenos Aires | |
| Argentina | Centro Medico Viamonte SRL | Ciudad Autonoma Buenos Aires | |
| Argentina | Clinical Trials Division-Stamboulian Servicios de Salud | Ciudad Autonoma Buenos Aires | |
| Argentina | Fundacion Huesped | Ciudad Autonoma De Buenos Aire | |
| Argentina | Clínica y Maternidad Suizo Argentina | Ciudad Autonoma de Buenos Aires | |
| Argentina | CEMIC Saavedra | Ciudad de Buenos Aires | |
| Argentina | Hospital J. M. Ramos Mejía | Ciudad de Buenos Aires | |
| Argentina | Hospital Italiano de La Plata | La Plata | |
| Argentina | Instituto Medico Platense | La Plata | |
| Argentina | DIM Clinica Privada | Ramos Mejia | |
| Brazil | Faculdade de Medicina Barretos FACISB | Barretos | |
| Brazil | Santa Casa de Misericordia de Belo Horizonte | Belo Horizonte | |
| Brazil | Universidade Federal De Minas Gerais - Hospital das Clínicas | Belo Horizonte | |
| Brazil | L2IP Instituto de Pesquisas Clinicas | Brasilia | |
| Brazil | Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro | Campinas | |
| Brazil | Fundacao Universidade Federal de Mato Grosso do Sul | Campo Grande | |
| Brazil | Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose | Criciúma | |
| Brazil | Oncovida - Centro de Onco-Hematologia de Mato Grosso | Cuiaba | |
| Brazil | Hospital Nossa Senhora Das Gracas | Curitiba | |
| Brazil | Centro de Estudos e Pesquisas em Moléstias Infecciosas | Natal | |
| Brazil | Hospital das Clinicas de Porto Alegre | Porto Alegre | |
| Brazil | Hospital Nossa Senhora da Conceicao S A | Porto Alegre | |
| Brazil | Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP | Ribeirao Preto | |
| Brazil | Fundacao Oswaldo Cruz | Rio de Janeiro | |
| Brazil | Instituto Brasil de Pesquisa Clinica | Rio de Janeiro | |
| Brazil | Ministerio da Saude - Hospital dos Servidores do Estado - RJ | Rio de Janeiro | |
| Brazil | Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu | Rio de Janeiro | |
| Brazil | Fundacao Bahiana De Infectologia | Salvador | |
| Brazil | Universidade Municipal de Sao Caetano do Sul | Sao Caetano do Sul | |
| Brazil | Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base | Sao Jose do Rio Preto | |
| Brazil | Centro de Referencia E Treinamento Dst/Aids | Sao Paulo | |
| Brazil | CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos | Sao Paulo | |
| Brazil | Hospital Das Clinicas Da Faculdade De Medicina Da USP | Sao Paulo | |
| Brazil | Instituto de infectologia Emilio Ribas | Sao Paulo | |
| Brazil | Real e Benemerita Associacao Portuguesa de Beneficencia | Sao Paulo | |
| Brazil | CPQuali Pesquisa Clinica LTDA ME | São Paulo | |
| Brazil | Sociedade Beneficente de Senhoras - Hospital Sírio Libanês | São Paulo | |
| Chile | Centro de Estudios Clínicos e Investigación Médica (CeCim) | Santiago | |
| Chile | Facultad de Medicina Universidad de Chile | Santiago | |
| Chile | Hospital Padre Hurtado | Santiago | |
| Chile | Centro de Investigacion del Maule | Talca | |
| Chile | Hospital Dr Hernan Henriquez Aravena | Temuco | |
| Chile | Centro de Estudios Clinicos V Region Ltda | Vina del Mar | |
| Colombia | Centro de Reumatologia y Ortopedia | Barranquilla | |
| Colombia | Clinica de la Costa | Barranquilla | |
| Colombia | Hospital Universidad del Norte | Barranquilla | |
| Colombia | Centro de Atencion e Investigacion Medica S.A. - CAIMED | Bogota | |
| Colombia | Medplus Medicina Prepagada S.A. | Bogota | |
| Colombia | Solano y Terront Servicios Médicos Ltda. | Bogota | |
| Colombia | Centro de Investigaciones Clinicas S A S | Cali | |
| Colombia | Fundación Valle del Lili | Cali | |
| Colombia | Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca | Floridablanca | |
| Colombia | Fundacion Oftalmologica de Santander - FOSCAL | Floridablanca | |
| Colombia | Fundacion Centro de Investigacion Clinica CIC | Medellin | |
| Colombia | Programa de Estudio y Control de Enfermedades Tropicales | Medellin | |
| Colombia | Hospital Pablo Tobon Uribe | Medellín | |
| Mexico | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Ciudad de Mexico | |
| Mexico | Instituto Nacional de Salud Publica | Cuernavaca | |
| Mexico | Hospital Civil Fray Antonio Alcalde | Guadalajara | |
| Mexico | Unidad de Atención Medica e Investigacion en Salud (UNAMIS) | Merida | |
| Mexico | CAIMED Investigacion en salud S.A de C.V. | Mexico | |
| Mexico | Centro Medico Nacional Siglo XXI IMSS | Mexico | |
| Mexico | Instituto Nacional de Enfermedades Respiratorias | Mexico | |
| Mexico | Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez' | Monterrey | |
| Mexico | Infectolab | Tijuana | |
| Peru | Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM) | Callao | |
| Peru | Centro de Invetigaciones Medicas | Callao | |
| Peru | Hospital Nacional Daniel Alcides Carrion | Callao | |
| Peru | Asociacion Civil Selva Amazonica (ACSA) | Iquitos | |
| Peru | Asociacion Civil Impacta Salud y Educacion- San Miguel CRS | Lima | |
| Peru | Asociacion Civil Via Libre | Lima | |
| Peru | Hospital Nacional Arzobispo Loayza | Lima | |
| Peru | Hospital Nacional Edgardo Rebagliati Martins | Lima | |
| Peru | Instituto de Investigacion Nutricional | Lima | |
| Peru | Asociacion Civil Impacta Salud y Educacion - Barranco | Lima - Barranco | |
| South Africa | Josha Research | Bloemfontein | |
| South Africa | Desmond Tutu HIV Foundation | Cape Town | |
| South Africa | Desmond Tutu Hiv Foundation - University Of Cape Town | Cape Town | |
| South Africa | Family Clinical Research Unit FAM-CRU | Cape Town | |
| South Africa | Masiphumelele Research Centre | Cape Town | |
| South Africa | Synexus Helderberg Clinical Research Centre | Cape Town | |
| South Africa | TASK Central | Cape Town | |
| South Africa | University of Cape Town IDM/CIDRI Research Site | Cape Town | |
| South Africa | Ndlovu Elandsdoorn Site | Dennilton | |
| South Africa | SA Medical Research Council | Durban | |
| South Africa | SA Medical Research Council | Durban | |
| South Africa | CRISMO Bertha Gxowa Research Centre | Johannesburg | |
| South Africa | Shandukani Research Centre | Johannesburg | |
| South Africa | The Aurum Institute Klerksdorp Clinical Research Centre | Klerksdorp | |
| South Africa | Centre for the AIDS Programme of Research in South Africa | KwaZulu-Natal | |
| South Africa | Qhakaza Mbokodo Research Centre | KwaZulu-Natal | |
| South Africa | South African Medical Research Council Chatsworth Clinical Research Site | KwaZulu-Natal | |
| South Africa | Stanza Clinical Research Centre : Mamelodi | Mamelodi East | |
| South Africa | Mzansi Ethical Research Centre | Middelburg | |
| South Africa | Nelson Mandela Academic Clinical Research Unit 'NeMACRU' | Mthatha | |
| South Africa | PHOENIX PHARMA (Pty) Ltd | Port Elizabeth | |
| South Africa | MeCRU Clinical Research Unit | Pretoria | |
| South Africa | Synexus Watermeyer | Pretoria | |
| South Africa | The Aurum Institute Rustenburg Clinical Research Site | Rustenburg | |
| South Africa | Setshaba Research Centre | Soshanguve | |
| South Africa | Perinatal HIV Research Unit (PHRU), Kliptown | Soweto | |
| South Africa | Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital | Soweto | |
| South Africa | The Aurum Institute: Tembisa - Clinic 4 | Tembisa | |
| South Africa | CAPRISA Vulindlela Clinic | Vulindlela | |
| South Africa | University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre | Westdene Johannesburg Gauteng | |
| South Africa | SATVI, Brewelskloof Hospital | Worcester | |
| United States | Synexus Clinical Research US Inc | Akron | Ohio |
| United States | Raymond G. Murphy VA Medical Center | Albuquerque | New Mexico |
| United States | Anaheim Clinical Trials, LLC | Anaheim | California |
| United States | Synexus Clinical Research US Inc | Anderson | South Carolina |
| United States | University of Michigan Neuorsurgery A. Alfred Taubman Health Care Center | Ann Arbor | Michigan |
| United States | Emory University of Medicine | Atlanta | Georgia |
| United States | Childrens Hospital Colorado | Aurora | Colorado |
| United States | Benchmark Research | Austin | Texas |
| United States | Optimal Research, LLC | Austin | Texas |
| United States | Baltimore VA Medical Center | Baltimore | Maryland |
| United States | Alabama Vaccine Research Clinic at UAB | Birmingham | Alabama |
| United States | Synexus Clinical Research US Inc | Birmingham | Alabama |
| United States | University of Alabama Birmingham | Birmingham | Alabama |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | The Brigham and Women's Hospital, Inc. | Boston | Massachusetts |
| United States | Bronx Veterans Affairs Medical Center | Bronx | New York |
| United States | Tryon Medical Group | Charlotte | North Carolina |
| United States | Jesse Brown VAMC Department of Surgery | Chicago | Illinois |
| United States | Northwestern University | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | The University Of Chicago Medicine | Chicago | Illinois |
| United States | University of IL Chicago | Chicago | Illinois |
| United States | CTI Clinical Trial and Consulting Services | Cincinnati | Ohio |
| United States | Synexus Clinical Research US Inc | Cincinnati | Ohio |
| United States | Velocity Clinical Research | Cincinnati | Ohio |
| United States | Rapid Medical Research | Cleveland | Ohio |
| United States | VA Medical Center | Columbia | South Carolina |
| United States | Synexus Clinical Research US Inc | Columbus | Ohio |
| United States | Corvallis Clinic PC | Corvallis | Oregon |
| United States | AIDS Arms Incorporated Trinity Health and Wellness Center | Dallas | Texas |
| United States | Baylor Scott & White Research Institute | Dallas | Texas |
| United States | North Texas Infectious Diseases Consultants | Dallas | Texas |
| United States | Synexus Clinical Research US Inc | Dallas | Texas |
| United States | Atlanta VA Medical Center | Decatur | Georgia |
| United States | The Hope Clinic at Emory University | Decatur | Georgia |
| United States | Avail Clinical Research, LLC | DeLand | Florida |
| United States | Rocky Mountain Regional VA Medical Center | Denver | Colorado |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Meridian Clinical Research, LLC | Endwell | New York |
| United States | Carolina Institute for Clinical Research | Fayetteville | North Carolina |
| United States | North Florida South Georgia Veteran Health System | Gainesville | Florida |
| United States | Synexus Clinical Research US Inc | Glendale | Arizona |
| United States | Cherry Street Services, Inc. | Grand Rapids | Michigan |
| United States | Velocity Clinical Research, Hallandale Beach | Hallandale Beach | Florida |
| United States | Research Centers of America, LLC | Hollywood | Florida |
| United States | Gordon Crofoot, MD | Houston | Texas |
| United States | Texas Center for Drug Development Inc | Houston | Texas |
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| United States | Optimal Research | Huntsville | Alabama |
| United States | University of Mississippi Medical Center | Jackson | Mississippi |
| United States | The Center For Pharmaceutical Research | Kansas City | Missouri |
| United States | Clinical Research Center of Nevada | Las Vegas | Nevada |
| United States | Clinical Research Consortium, an AMR company | Las Vegas | Nevada |
| United States | Johnson County Clin-Trials | Lenexa | Kansas |
| United States | Central Kentucky Research Associates, Inc. | Lexington | Kentucky |
| United States | University of Kentucky | Lexington | Kentucky |
| United States | Central Arkansas Veterans Healthcare System | Little Rock | Arkansas |
| United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| United States | Ark Clinical Research | Long Beach | California |
| United States | Anthony Mills Medical, Inc | Los Angeles | California |
| United States | University of Louisville | Louisville | Kentucky |
| United States | Clinical Research Institute of Southern Oregon, P.C. | Medford | Oregon |
| United States | St Jude Children's Research Hospital | Memphis | Tennessee |
| United States | Benchmark Research | Metairie | Louisiana |
| United States | Clinical Trials Management, LLC | Metairie | Louisiana |
| United States | Suncoast Research Group | Miami | Florida |
| United States | University of Miami - Miller School of Medicine | Miami | Florida |
| United States | Abbott Northwestern Hospital Clinic | Minneapolis | Minnesota |
| United States | Coastal Carolina Research Center | Mount Pleasant | South Carolina |
| United States | PMG Research of Charleston, LLC | Mount Pleasant | South Carolina |
| United States | Synexus Clinical Research US Inc | Murray | Utah |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey |
| United States | New Orleans Adolescent Trials Unit CRS | New Orleans | Louisiana |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Southeast Louisiana Veterans Health Care Center | New Orleans | Louisiana |
| United States | Harlem Hospital Center | New York | New York |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | New York Blood Center | New York | New York |
| United States | Saint Michaels Medical Center | Newark | New Jersey |
| United States | Advent Health Orlando | Orlando | Florida |
| United States | Orlando Immunology Center | Orlando | Florida |
| United States | Synexus Clinical Research US Inc | Orlando | Florida |
| United States | Stanford University Medical Center | Palo Alto | California |
| United States | Optimal Research | Peoria | Illinois |
| United States | MediSync Clinical Research | Petal | Mississippi |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Central Phoenix Medical Clinic | Phoenix | Arizona |
| United States | VA Medical Center | Phoenix | Arizona |
| United States | Synexus Clinical Research US Inc | Pinellas Park | Florida |
| United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | Oregon Health And Science University | Portland | Oregon |
| United States | Durham VAMC | Raleigh | North Carolina |
| United States | Wake Research Associates | Raleigh | North Carolina |
| United States | VA Sierra Nevada Health Care System | Reno | Nevada |
| United States | Rochester Clinical Research, Inc | Rochester | New York |
| United States | Meridian Clinical Research, LLC | Rockville | Maryland |
| United States | Optimal Research | Rockville | Maryland |
| United States | Saint Louis University | Saint Louis | Missouri |
| United States | Synexus Clinical Research US Inc | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | University of Utah | Salt Lake City | Utah |
| United States | Clinical Trials of Texas, Inc | San Antonio | Texas |
| United States | Synexus Clinical Research US Inc | San Antonio | Texas |
| United States | UCSD Antiviral Research Center AVRC | San Diego | California |
| United States | Wr-McCr, Llc | San Diego | California |
| United States | VA Medical Center | San Francisco | California |
| United States | Kaiser Permanente Washington Health Research Institute | Seattle | Washington |
| United States | Spartanburg Medical Research | Spartanburg | South Carolina |
| United States | James A Haley VA Hospital GNS | Tampa | Florida |
| United States | Synexus Clinical Research US Inc | The Villages | Florida |
| United States | Quality of Life Medical & Research Center, LLC | Tucson | Arizona |
| United States | Synexus Clinical Research US Inc | Tucson | Arizona |
| United States | Buynak Clinical Research | Valparaiso | Indiana |
| United States | Advanced Clinical Research | West Jordan | Utah |
| United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Vaccines & Prevention B.V. |
United States, Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6 | |
| Primary | 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. | From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6 | |
| Primary | 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). | Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1]) | |
| Primary | 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. | Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1]) | |
| Primary | 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. | Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1]) | |
| Secondary | 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. | From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6 | |
| Secondary | 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. | From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6 | |
| Secondary | 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. | 1 day after double-blind vaccination on Day 1 (Day 2) | |
| Secondary | 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. | 14 days after double-blind vaccination on Day 1 (Day 15) | |
| Secondary | 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. | 28 days after double-blind vaccination on Day 1 (Day 29) | |
| Secondary | 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. | 14 days after double-blind vaccination on Day 1 (Day 15) | |
| Secondary | 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. | 28 Days after double-blind vaccination on Day 1 (Day 29) | |
| Secondary | 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. | From Day 15 to end of the COVID-19 episode (Day 189) | |
| Secondary | 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. | 14 Days after double-blind vaccination on Day1 (Day 15) | |
| Secondary | 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. | 28 Days after double-blind vaccination on Day 1 (Day 29) | |
| Secondary | 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. | 14 Days after double-blind vaccination on Day 1 (Day 15) | |
| Secondary | 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. | 28 Days after double-blind vaccination on Day 1 (Day 29) | |
| Secondary | 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. | 14 Days after double-blind vaccination on Day 1 (Day 15) | |
| Secondary | 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. | 28 Days after double-blind vaccination on Day 1 (Day 29) | |
| Secondary | 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. | From Day 29 until end of double-blind phase at Month 6 | |
| Secondary | 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. | Month 6 | |
| Secondary | 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. | 28 days after double-blind vaccination on Day 1 (Day 29) | |
| Secondary | 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. | 1 day after double-blind vaccination on Day 1 (Day 2) | |
| Secondary | 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. | Baseline (Day 1) up to 35 weeks | |
| Secondary | 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. | Baseline (Day 1) up to 35 weeks | |
| Secondary | 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. | Up to 6 months after double-blind vaccination on Day 1 (up to 6 months) | |
| Secondary | 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. | Up to 35 weeks | |
| Secondary | 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). | Up to Day 8 (7 Days after double-blind vaccination on Day 1) | |
| Secondary | 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. | Up to Day 8 (7 Days after double-blind vaccination on Day 1) | |
| Secondary | 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. | Up to Day 29 (28 Days after double-blind vaccination on Day 1) | |
| Secondary | 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). | Baseline (Day 1), Day 29, and Day 71 | |
| Secondary | 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. | 28 days after booster vaccination on Day 365 (up to Day 393) | |
| Secondary | 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. | 29 days after booster vaccination on Day 365 (Day 394) |