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

Primary Purpose

Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ad26.COV2.S
Placebo
Sponsored by
Janssen Vaccines & Prevention B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

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 has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients
  • 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 within 30 days (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or investigational 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

Sites / Locations

  • Achieve Clinical Research, LLC
  • Hope Research Institute
  • Central Phoenix Medical Clinic
  • Quality of Life Medical & Research Center, LLC
  • Synexus Clinical Research US, Inc
  • Woodland International Research Group
  • Synexus Clinical Research US, Inc
  • eStudySite
  • Ark Clinical Research
  • Anthony Mills Medical, Inc
  • Benchmark Research
  • Artemis Institute for Clinical Research
  • Paradigm Clinical Research Centers, Inc.
  • JEM Research, LLC
  • Prestige Clinical Research Center, Inc.
  • Avail Clinical Research, LLC
  • Velocity Clinical Research, Hallandale Beach
  • Health Awareness inc.
  • Altus Research, Inc
  • Compass Research, Melbourne
  • Suncoast Research Group
  • Behavioral Clinical Research , Inc
  • Clinical NeuroScience Solutions, Inc
  • Progressive Medical Research
  • Meridien Research
  • Palm Beach Research Center
  • Atlanta Center for Medical Research
  • Accel Research Sites
  • The University Of Chicago Medicine
  • Great Lakes Clinical Trials
  • The South Bend Clinic Center for Research
  • Heartland Research Associates, LLC
  • University of Kentucky
  • Centex Studies, Inc.
  • Ochsner Clinic Foundation
  • Centennial Medical Group
  • Optimal Research
  • Meridian Clinical Research, LLC
  • Henry Ford Health Systems
  • Cherry Street Services, Inc.
  • Washington University School of Medicine
  • Hassman Research Institute, LLC.
  • Jersey Shore University Medical Center
  • Medpharmics, LLC
  • Meridian Clinical Research, LLC
  • Regional Clinical Research, Inc.
  • Allergy Asthma Immunology of Rochester, PC (AAIR) - Research Center
  • Richmond Behavioral Associates
  • American Health Network, LLC
  • Wilmington Health Associates
  • CTI Clinical Trial and Consulting Services
  • Lynn Health Science Institute
  • Medical University of South Carolina
  • Coastal Carolina Research Center
  • Centennial Medical Center
  • Centex Studies, Inc.
  • Centex Studies, Inc.
  • Texas Center for Drug Development, Inc
  • Centex Studies, Inc.
  • Endeavor Clinical Trials, LLC
  • Tranquility Clinical Research
  • JBR Clinical Research
  • Alliance for Multispeciality Research
  • Anima
  • Institute of Tropical Medicine Antwerp
  • Center for Vaccinology (CEVAC)
  • UZ Leuven
  • Az Sint-Maarten
  • Private Practice RESPISOM Namur
  • Hospital Nossa Senhora da Conceicao S.A
  • Ministerio da Saude - Hospital dos Servidores do Estado - RJ
  • Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ
  • Instituto de infectologia Emilio Ribas
  • Centro de Referencia E Treinamento Dst/Aids
  • Fundacion Cardiomet CEQUIN
  • IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
  • Asistencia Cientifica de Alta Complejidad S.A.S
  • Centro Medico Imbanaco de Cali S.A.
  • T Y C Inversiones S A S Grupsalud
  • CHU de Montpellier, Hopital Saint-Eloi
  • Hopital Saint-Antoine
  • Hopital Cochin
  • Groupe Hospitalier Sud Hôpital Haut-Leveque Service d'hematologie
  • CHU Saint-Etienne - Hôpital Nord
  • Hopital Purpan
  • Hopital Rangueil
  • Hôpital de Brabois Adultes
  • Klinikum rechts der Isar der TU Munchen
  • Riverside Medical Center
  • West Visayas State University Medical Center
  • Tropical Disease Foundation
  • Makati Medical Center
  • Medical Center Manila
  • TREAD Research Tygerberg Hospital
  • Centre of Tuberculosis Research Innovation
  • Worthwhile Clinical trials
  • Peermed Clinical Trial Centre
  • Dr AA Mahomed Medical Centre
  • VX Pharma
  • Dr J.M. Engelbrecht Trial Site
  • Be Part Yoluntu Centre
  • Hosp. Univ. Germans Trias I Pujol
  • Hosp. Quiron Barcelona
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. Vall D Hebron
  • Hosp. Univ. de La Princesa
  • Clinica Univ. de Navarra
  • Hosp. Univ. de La Paz
  • Hosp. Quiron Madrid Pozuelo
  • Clinica Univ. de Navarra
  • Queen Elizabeth Hospital
  • Powys Teaching Local Health Board - Bronllys Hospital
  • Brighton & Sussex University Hospitals NHS Trust
  • University Hospitals Bristol NHS Trust
  • Cambridge University Hospitals NHS Foundation Trust
  • Ninewells Hospital
  • Royal Free Hospital
  • Leicester Royal Infirmary
  • Guy's and St Thomas' Hospital
  • Imperial College London and Imperial College Healthcare NHS Trust
  • Central Manchester University Hospitals NHS Foundation Trust
  • Newcastle upon Tyne Hospitals NHS Foundation Trust
  • University of Oxford
  • Derriford Hospital
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ad26.COV2.S

Placebo

Arm Description

Participants will receive intramuscular (IM) injection of Ad26.COV2.S vaccine on Day 1 and Day 57 in the double-blind phase. At unblinding visit (open-label phase), participants who have not yet received second vaccination will receive second dose of Ad26.COV2.S vaccine on Day 57, if applicable and newly enrolled participants will either receive IM injection of one dose of Ad26.COV2.S vaccine on Day 1 or two doses of Ad26.COV2.S vaccine on Day 1 and Day 57. All ongoing participants who only received a single vaccination with Ad26.COV2.S in the study will be offered to receive single booster dose of Ad26.COV2.S in the open label phase preferably within 6 to 12 months after the participant's first Ad26.COV2.S vaccination.

Participants will receive IM injection of placebo on Day 1 and Day 57 in the double-blind phase. At unblinding visit (open-label phase), participants initially receiving placebo will be offered to receive IM injection of a single dose of Ad26.COV2.S vaccine. All ongoing participants who only received a single vaccination with Ad26.COV2.S in the study will be offered to receive single booster dose of Ad26.COV2.S in the open label phase preferably within 6 to 12 months after the participant's first Ad26.COV2.S vaccination.

Outcomes

Primary Outcome Measures

Double Blind Phase and Open-label Phase: Number of Participants with Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of signs and symptoms or severe COVID-19 defined in Food and Drug Administration (FDA) guidance.

Secondary Outcome Measures

Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Double Blind Phase: Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention
Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray, computed tomographic [CT] findings) and linked to any molecularly confirmed COVID-19 at least 14 days after the second vaccination will be reported.
Double Blind Phase: 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
The viral load of Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) will be assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs will be used to detect and/or quantify SARS-CoV-2.
Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19
Molecularly confirmed mild COVID-19 is 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. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea.
Double Blind Phase: Number of Participants with First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition
Molecularly confirmed moderate and severe/critical COVID-19 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 this 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.
Double Blind Phase: Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19
BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate, or severe/critical COVID-19 case.
Double Blind Phase: Serologic Conversion Between Baseline and Other Blood Samples up to Unblinding Visit Using an Enzyme-linked Immunosorbent Assay (ELISA)
Serologic conversion between baseline and other blood samples up to unblinding visit using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported.
Double Blind Phase: Number of Participants With Asymptomatic Infection Detected By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)
Number of participants with asymptomatic infection as assessed by RT-PCR will be reported.
Double Blind Phase: Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed)
Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after second vaccination (Day 71) to end of Study (2.3 years) will be reported.
Double Blind Phase and Open-label Phase: Number of Participants with Serious Adverse Events (SAEs)
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.
Double Blind Phase and Open-label Phase: Number of Participants with Adverse Events of Special Interest (AESIs)
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.
Double Blind Phase and Open-label Phase: Number of Participants with Medically-attended Adverse Events (MAAEs)
MAAEs are 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 will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Double Blind Phase and Open-label Phase: Number of Participants with Medically-attended Adverse Events (MAAEs) Leading to Study Discontinuation
MAAEs are 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 will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Double Blind Phase: Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination
Participants will be 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 each vaccination (day of each vaccination and the subsequent 7 days).
Double Blind Phase: Number of Participants with Solicited Systemic AEs During 7 Days Following Each Vaccination
Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Participants should record the temperature in the e-Diary in the evening of the day of each vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post each vaccination (day of each vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Double Blind Phase: Number of Participants with Unsolicited Adverse Events (AEs) During 28 Days Post-vaccination
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Double Blind Phase: SARS-CoV-2 Binding Antibodies Assessed by ELISA
SARS-CoV-2 binding antibodies as assessed ELISA to measure humoral immune response will be reported.

Full Information

First Posted
November 3, 2020
Last Updated
July 21, 2023
Sponsor
Janssen Vaccines & Prevention B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04614948
Brief Title
A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults
Acronym
ENSEMBLE 2
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
June 18, 2023 (Actual)
Study Completion Date
June 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Vaccines & Prevention B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults in the double-blind phase and to describe COVID-19 outcomes, safety, and immunogenicity in the different study cohorts in open-label phase.
Detailed Description
The aim of the COVID-19 vaccine clinical development program is to develop a safe and effective vaccine for the prevention of COVID-19. Ad26.COV2.S, a COVID-19 vaccine based on a human replication-incompetent Ad26 vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus spike (S) protein, is being developed. The study will consist of: a screening phase (up to 28 days), study period (60-week), and a long-term follow-up period (1 additional year). The total study duration will be maximum 2 years and 3 months for the participants. Assessments for efficacy (COVID-19 signs and symptoms, etc.), immunogenicity (such as humoral immune responses), and safety (such as adverse events [AEs] monitoring) will be performed throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31831 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ad26.COV2.S
Arm Type
Experimental
Arm Description
Participants will receive intramuscular (IM) injection of Ad26.COV2.S vaccine on Day 1 and Day 57 in the double-blind phase. At unblinding visit (open-label phase), participants who have not yet received second vaccination will receive second dose of Ad26.COV2.S vaccine on Day 57, if applicable and newly enrolled participants will either receive IM injection of one dose of Ad26.COV2.S vaccine on Day 1 or two doses of Ad26.COV2.S vaccine on Day 1 and Day 57. All ongoing participants who only received a single vaccination with Ad26.COV2.S in the study will be offered to receive single booster dose of Ad26.COV2.S in the open label phase preferably within 6 to 12 months after the participant's first Ad26.COV2.S vaccination.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive IM injection of placebo on Day 1 and Day 57 in the double-blind phase. At unblinding visit (open-label phase), participants initially receiving placebo will be offered to receive IM injection of a single dose of Ad26.COV2.S vaccine. All ongoing participants who only received a single vaccination with Ad26.COV2.S in the study will be offered to receive single booster dose of Ad26.COV2.S in the open label phase preferably within 6 to 12 months after the participant's first Ad26.COV2.S vaccination.
Intervention Type
Biological
Intervention Name(s)
Ad26.COV2.S
Other Intervention Name(s)
JNJ-78436735, Ad26COVS1, VAC31518
Intervention Description
Ad26.COV2.S vaccine will be administered on Day 1 and Day 57 in the double-blind phase. At unblinding visit Ad26.COV2.S vaccine will be administered to participants at Day 57 who have not yet received second vaccination and in newly enrolled participants as either single dose on Day 1 or two doses on Day 1 and Day 57. Single dose of Ad26.COV2.S vaccine will also be administered to participants initially receiving placebo. Single booster dose of Ad26.COV2.S vaccine will be given to participants in the open label phase who have received only a single vaccination with Ad26.COV2.S.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as IM injection on Day 1 and Day 57.
Primary Outcome Measure Information:
Title
Double Blind Phase and Open-label Phase: Number of Participants with Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19
Description
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of signs and symptoms or severe COVID-19 defined in Food and Drug Administration (FDA) guidance.
Time Frame
At least 14 days after the second vaccination (Day 71) to the end of study (2 years and 3 months [after last participant enrolled])
Secondary Outcome Measure Information:
Title
Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus
Description
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Time Frame
1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months)
Title
Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus
Description
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Time Frame
14 days after the second vaccination (Day 71) to end of study (2 years and 3 months)
Title
Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline
Description
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Time Frame
1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months)
Title
Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline
Description
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Time Frame
14 days after the 1st vaccination (Day 15) to end of study (2 years and 3 months)
Title
Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline
Description
Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Time Frame
28 days after the 1st vaccination (Day 29) to end of study (2 years and 3 months)
Title
Double Blind Phase: Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention
Description
Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray, computed tomographic [CT] findings) and linked to any molecularly confirmed COVID-19 at least 14 days after the second vaccination will be reported.
Time Frame
At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months)
Title
Double Blind Phase: 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
Description
The viral load of Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) will be assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs will be used to detect and/or quantify SARS-CoV-2.
Time Frame
At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months)
Title
Double Blind Phase: Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19
Description
Molecularly confirmed mild COVID-19 is 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. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea.
Time Frame
At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months)
Title
Double Blind Phase: Number of Participants with First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition
Description
Molecularly confirmed moderate and severe/critical COVID-19 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 this 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
At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months)
Title
Double Blind Phase: Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19
Description
BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate, or severe/critical COVID-19 case.
Time Frame
At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months)
Title
Double Blind Phase: Serologic Conversion Between Baseline and Other Blood Samples up to Unblinding Visit Using an Enzyme-linked Immunosorbent Assay (ELISA)
Description
Serologic conversion between baseline and other blood samples up to unblinding visit using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported.
Time Frame
Between baseline and unblinding visit (up to 6 months)
Title
Double Blind Phase: Number of Participants With Asymptomatic Infection Detected By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)
Description
Number of participants with asymptomatic infection as assessed by RT-PCR will be reported.
Time Frame
Up to 2 years and 3 months
Title
Double Blind Phase: Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed)
Description
Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after second vaccination (Day 71) to end of Study (2.3 years) will be reported.
Time Frame
At least 14 days after the second vaccination (Day 71) to end of study (2 years and 3 months)
Title
Double Blind Phase and Open-label Phase: Number of Participants with Serious Adverse Events (SAEs)
Description
SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time Frame
Up to 2 years and 3 months
Title
Double Blind Phase and Open-label Phase: Number of Participants with Adverse Events of Special Interest (AESIs)
Description
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.
Time Frame
Up to 2 years and 3 months
Title
Double Blind Phase and Open-label Phase: Number of Participants with Medically-attended Adverse Events (MAAEs)
Description
MAAEs are 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 will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Time Frame
6 months after the last vaccination (Up to 34 weeks)
Title
Double Blind Phase and Open-label Phase: Number of Participants with Medically-attended Adverse Events (MAAEs) Leading to Study Discontinuation
Description
MAAEs are 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 will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Time Frame
Up to 2 years and 3 months
Title
Double Blind Phase: Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination
Description
Participants will be 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 each vaccination (day of each vaccination and the subsequent 7 days).
Time Frame
Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57)
Title
Double Blind Phase: Number of Participants with Solicited Systemic AEs During 7 Days Following Each Vaccination
Description
Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Participants should record the temperature in the e-Diary in the evening of the day of each vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post each vaccination (day of each vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Time Frame
Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57)
Title
Double Blind Phase: Number of Participants with Unsolicited Adverse Events (AEs) During 28 Days Post-vaccination
Description
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Time Frame
Up to Day 29 (28 days after first vaccination on Day 1), up to Day 85 (28 days after second vaccination on Day 57)
Title
Double Blind Phase: SARS-CoV-2 Binding Antibodies Assessed by ELISA
Description
SARS-CoV-2 binding antibodies as assessed ELISA to measure humoral immune response will be reported.
Time Frame
Up to 2 years and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) 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 has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients 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 within 30 days (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or investigational 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Vaccines & Prevention B.V. Clinical Trial
Organizational Affiliation
Janssen Vaccines & Prevention B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Achieve Clinical Research, LLC
City
Vestavia Hills
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Central Phoenix Medical Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Quality of Life Medical & Research Center, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
eStudySite
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Ark Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Anthony Mills Medical, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Benchmark Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95684
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc.
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
JEM Research, LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Prestige Clinical Research Center, Inc.
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Velocity Clinical Research, Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Health Awareness inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Altus Research, Inc
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Compass Research, Melbourne
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Behavioral Clinical Research , Inc
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Clinical NeuroScience Solutions, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Accel Research Sites
City
Eatonton
State/Province
Georgia
ZIP/Postal Code
31204
Country
United States
Facility Name
The University Of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
The South Bend Clinic Center for Research
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617-2808
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Centex Studies, Inc.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Optimal Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Henry Ford Health Systems
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Cherry Street Services, Inc.
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1035
Country
United States
Facility Name
Hassman Research Institute, LLC.
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Medpharmics, LLC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Regional Clinical Research, Inc.
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Allergy Asthma Immunology of Rochester, PC (AAIR) - Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
American Health Network, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Wilmington Health Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
CTI Clinical Trial and Consulting Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77073
Country
United States
Facility Name
Texas Center for Drug Development, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Centex Studies, Inc.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
Endeavor Clinical Trials, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Tranquility Clinical Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Alliance for Multispeciality Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Anima
City
Alken
ZIP/Postal Code
3570
Country
Belgium
Facility Name
Institute of Tropical Medicine Antwerp
City
Antwerpen
ZIP/Postal Code
2000
Country
Belgium
Facility Name
Center for Vaccinology (CEVAC)
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Az Sint-Maarten
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Private Practice RESPISOM Namur
City
Namur
ZIP/Postal Code
5101
Country
Belgium
Facility Name
Hospital Nossa Senhora da Conceicao S.A
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Ministerio da Saude - Hospital dos Servidores do Estado - RJ
City
Rio de Janeiro
ZIP/Postal Code
20221-160
Country
Brazil
Facility Name
Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ
City
Rio de Janeiro
ZIP/Postal Code
21040-900
Country
Brazil
Facility Name
Instituto de infectologia Emilio Ribas
City
Sao Paulo
ZIP/Postal Code
01246-900
Country
Brazil
Facility Name
Centro de Referencia E Treinamento Dst/Aids
City
Sao Paulo
ZIP/Postal Code
02141-000
Country
Brazil
Facility Name
Fundacion Cardiomet CEQUIN
City
Armenia
Country
Colombia
Facility Name
IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Facility Name
Asistencia Cientifica de Alta Complejidad S.A.S
City
Bogota
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A.
City
Cali
ZIP/Postal Code
760042
Country
Colombia
Facility Name
T Y C Inversiones S A S Grupsalud
City
Santa Marta
ZIP/Postal Code
470001
Country
Colombia
Facility Name
CHU de Montpellier, Hopital Saint-Eloi
City
Montpellier
ZIP/Postal Code
34295 cedex 05
Country
France
Facility Name
Hopital Saint-Antoine
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Groupe Hospitalier Sud Hôpital Haut-Leveque Service d'hematologie
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Saint-Etienne - Hôpital Nord
City
Saint-Etienne Cedex 2
ZIP/Postal Code
42055
Country
France
Facility Name
Hopital Purpan
City
Toulouse Cedex 09
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Rangueil
City
Toulouse
ZIP/Postal Code
31054
Country
France
Facility Name
Hôpital de Brabois Adultes
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Klinikum rechts der Isar der TU Munchen
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Riverside Medical Center
City
Bacolod
ZIP/Postal Code
6100
Country
Philippines
Facility Name
West Visayas State University Medical Center
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Tropical Disease Foundation
City
Makati
ZIP/Postal Code
1230
Country
Philippines
Facility Name
Makati Medical Center
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Medical Center Manila
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
TREAD Research Tygerberg Hospital
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Centre of Tuberculosis Research Innovation
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Worthwhile Clinical trials
City
Johannesburg
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Peermed Clinical Trial Centre
City
Kempton Park
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Dr AA Mahomed Medical Centre
City
Moloto
ZIP/Postal Code
1022
Country
South Africa
Facility Name
VX Pharma
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Dr J.M. Engelbrecht Trial Site
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Be Part Yoluntu Centre
City
Western Cape
ZIP/Postal Code
7626
Country
South Africa
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Quiron Barcelona
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08063
Country
Spain
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hosp. Univ. de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Clinica Univ. de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hosp. Univ. de La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Powys Teaching Local Health Board - Bronllys Hospital
City
Brecon
ZIP/Postal Code
LD3 0UL
Country
United Kingdom
Facility Name
Brighton & Sussex University Hospitals NHS Trust
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Trust
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Royal Free Hospital
City
Hampstead
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Facility Name
Guy's and St Thomas' Hospital
City
London,
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Imperial College London and Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Central Manchester University Hospitals NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
University of Oxford
City
Oxford
ZIP/Postal Code
OX3 7JX
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2SB
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Citations:
PubMed Identifier
36113538
Citation
Hardt K, Vandebosch A, Sadoff J, Le Gars M, Truyers C, Lowson D, Van Dromme I, Vingerhoets J, Kamphuis T, Scheper G, Ruiz-Guinazu J, Faust SN, Spinner CD, Schuitemaker H, Van Hoof J, Douoguih M, Struyf F; ENSEMBLE2 study group. Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2022 Dec;22(12):1703-1715. doi: 10.1016/S1473-3099(22)00506-0. Epub 2022 Sep 13. Erratum In: Lancet Infect Dis. 2022 Nov 7;:
Results Reference
derived

Learn more about this trial

A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults

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