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Our Commitment to Transparency

At Johnson & Johnson, we believe the transparency of clinical trial data advances science and medicine and is in the best interest of the patients and consumers who use our pharmaceutical products and the healthcare professionals who prescribe them. We support the overall principles of clinical trial data transparency with the goal of advancing medical sciences.

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) publicly disclose information about our clinical trials in external public registries, such as ClinicalTrials.gov and the EU Clinical Trials Register. We also respect and uphold the principles developed by the pharmaceutical industry: PhRMA Principles for Responsible Clinical Trial Data Sharing and the International Federation of Pharmaceutical Manufacturers & Associations Principles for Responsible Clinical Trial Data Sharing. We expeditiously seek publication of all results from clinical trials in in patients in peer-reviewed medical journals, and after regulatory approval, we make both our Clinical Study Reports and clinical trial participant data available for sharing with researchers through the Yale University Open Data Access (YODA) Project.

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) is committed to sharing information related to the Phase 3 studies of its investigational COVID-19 vaccine candidate – The ‘ENSEMBLE Study’ and the ‘ENSEMBLE 2 Study’ – including details of our study protocols.

ENSEMBLE

  • The study was primarily designed to monitor participants until approximately 154 cases of confirmed moderate-to-severe COVID-19 have been seen, and to follow the participants for up to 2-years even if efficacy is established earlier. This will allow establishment of vaccine efficacy in line with the statistical requirements detailed in the FDA Guidance Document entitled ‘Development and Licensure of Vaccines to Prevent COVID-19.'
  • The study also allows for real-time counting of COVID-19 cases as they occur in case the pre-specified statistical requirements for vaccine efficacy are met even before reaching 154 cases. This might occur if the vaccine is even more effective than what was assumed when designing the study. This evaluation will be done through the Study Data and Safety Monitoring Board (DSMB), a group of experts that is independent from Janssen.
  • The real-time counting may start after observing 20 of the required moderate-to-severe COVID-19 cases and only after meeting additional criteria in order to ensure adequate information is collected to assess the benefit/risk based on safety and efficacy after vaccination. The criteria include requirements for: post vaccination follow-up time, number of observed severe/critically ill cases, and number of required observed events among clinical trial participants who are 60 years or older.

ENSEMBLE 2

  • The study was primarily designed to monitor participants until approximately 104 cases of confirmed moderate-to-severe COVID-19 have been seen, and to follow the participants for up to 2-years even if efficacy is established earlier. This will allow establishment of vaccine efficacy in line with the statistical requirements detailed in the FDA Guidance Document entitled ‘Development and Licensure of Vaccines to Prevent COVID-19.'
  • The study also allows for real-time counting of COVID-19 cases as they occur in case the pre-specified statistical requirements for vaccine efficacy are met even before reaching 104 cases. This might occur if the vaccine is even more effective than what was assumed when designing the study. This evaluation will be done through the Study Data and Safety Monitoring Board (DSMB), a group of experts that is independent from Janssen.
  • The real-time counting may start after observing a minimum of 6 COVID-19 cases for the ≥60 years age group or at least 20 of the required moderate-to-severe COVID-19 cases and only after meeting additional criteria in order to ensure adequate information is collected to assess the benefit/risk based on safety and efficacy after vaccination. The criteria include requirements for: post vaccination follow-up time, number of observed severe/critically ill cases, and number of required observed events among clinical trial participants who are 60 years or older.

Included below are the Study Overview sections of the informed consent for participants enrolling in our Phase 3 studies.

About Our ENSEMBLE Study

Why are these studies being done?
These studies are being done to test Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S. Doctors and scientists hope it will prevent or lessen the severity of disease caused by severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2). This virus causes a disease called COVID-19. The SARS-CoV-2 virus is passed from person to person primarily by small droplets from the nose or mouth when an infected person coughs, sneezes or speaks. Most people who are infected have mild COVID-19 disease such as cough and tiredness, but some people have severe disease and can even die.

Ad26.COV2.S may help to prevent disease by stimulating the human body to form an immune response against the virus that causes the disease. This defensive response is a way your body fights infections. This study will help determine if Ad26.COV2.S is safe for humans and protective against COVID-19 disease.

The main purposes of these studies are to see

  1. If the Ad26.COV2.S vaccine is safe
  2. To learn more about the side effects caused by the Ad26.COV2.S vaccine
  3. If the Ad26.COV2.S vaccine helps to prevent or lessen the severity of COVID-19.

In these studies, half of the participants will get a placebo instead of the Ad26.COV2.S vaccine. The placebo looks just like the Ad26.COV2.S vaccine and is given the same way: by injection (shot). But the placebo contains no active vaccine. Using a placebo in the study allows researchers to see potential differences between the investigational vaccine and the placebo. The placebo in these studies will be sodium chloride, also known as saline (saltwater).

Throughout this page, when the words “study vaccine” are used, they can mean Ad26.COV2.S or placebo.

ENSEMBLE

General Information about the study
Nearly 45,000 participants around the world are taking part in this study.

Participants who join the study will be in it for about 2 years. During the study staff will collect blood samples, saliva samples and nasal swabs. If you become sick with COVID-19 (you cannot get COVID-19 from the vaccine), the study staff will monitor you daily and request that you provide extra nasal swabs and saliva samples.

During the study, the company may learn new information about the study vaccine such as risks. Your study doctor will tell you as soon as possible about any new information that might make you change your mind about being in the study. It is possible that you will not benefit from participating in this study because we do not know if the vaccine works to prevent COVID-19 disease. There is a small chance you may have a bad reaction to the vaccine or that the vaccine may make you sicker if you do get COVID-19.

The study will be conducted in two stages for each age group. The first group consists of 2000 participants aged 18-59 who do not have other health conditions. After they have received the injection of the study vaccine or placebo and have been observed for 3 days following the injection, all the remaining participants in that age group will be enrolled. The same process will be followed for the group aged 60 and older. Participants will be informed whether they are in the first group or in the second group. If you do not qualify for the first group of participants due to other health conditions, you may still qualify for the second group of participants.

You may choose to not participate in this study, in which case you will not lose access to any medical care or other benefits already available to you or that you may need in the future.

In addition to funding from Johnson & Johnson, this study is co-funded by Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Health, both of which are part of U.S. Department of Health and Human Services.

ENSEMBLE 2

Up to 30,000 participants around the world will take part in this study.

Participants who join the study will be in it for about 2 years. During the study staff will collect blood samples, saliva samples and nasal swabs. If you become sick with COVID-19 (you cannot get COVID-19 from the vaccine), the study staff will monitor you daily and request that you provide extra nasal swabs and saliva samples.

During the study, the company may learn new information about the study vaccine such as risks. Your study doctor will tell you as soon as possible about any new information that might make you change your mind about being in the study. It is possible that you will not benefit from participating in this study because we do not know if the vaccine works to prevent COVID-19 disease. There is a small chance you may have a bad reaction to the vaccine or that the vaccine may make you sicker if you do get COVID-19.

The study will be conducted in two stages for each age group. The first group consists of 1,000 participants aged 18-59 who do not have other health conditions. After they have received the injection of the study vaccine or placebo and have been observed for 3 days following the injection, all the remaining participants in that age group will be enrolled. The same process will be followed for the group aged 60 and older. Participants will be informed whether they are in the first group or in the second group. If you do not qualify for the first group of participants due to other health conditions, you may still qualify for the second group of participants.

You may choose to not participate in this study, in which case you will not lose access to any medical care or other benefits already available to you or that you may need in the future.

_ _ _ _ _ _ _ _ _ _

For additional information about the ENSEMBLE and ENSEMBLE 2 Studies, please click here.

For additional details regarding the ENSEMBLE Study protocol, please click here.*

For additional details regarding the ENSEMBLE 2 Study protocol, please click here.**

* This link will take you to the version of the study protocol as of December 14, 2020. Please note any amendments and updates to the protocol will be made according to local requirements and relevant information from the protocol will be available on regional registries such as www.ClinicalTrials.gov.

** This link will take you to the version of the study protocol as of December 18, 2020. Please note any amendments and updates to the protocol will be made according to local requirements and relevant information from the protocol will be available on regional registries such as www.ClinicalTrials.gov.

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