E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy Volunteers, with or without comorbidities (Prevention of SARS-CoV-2-mediated COVID-19) |
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E.1.1.1 | Medical condition in easily understood language |
Healthy Volunteers, some of which may have an underlying medical condition (Prevention of COVID-19) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084465 |
E.1.2 | Term | COVID-19 vaccination |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Double-blind phase: To demonstrate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed, moderate to severe/critical COVID-19, as compared to placebo, in SARS-CoV-2 seronegative adults |
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E.2.2 | Secondary objectives of the trial |
Double-blind phase: - To demonstrate the efficacy of Ad26.COV2.S in the prevention of moderate to severe/critical COVID-19 in adults regardless of their serostatus - To evaluate the efficacy of Ad26.COV2.S in the prevention of moderate to severe/critical COVID-19 - To assess the effect of Ad26.COV2.S on: 1. COVID-19 requiring medical intervention 2. SARS-CoV-2 viral RNA load for moderate to severe/critical COVID-19 3. Mild COVID-19 4. COVID-19 as defined by the US FDA harmonized case definition 5. All molecularly confirmed symptomatic COVID-19 6. Occurrence of confirmed asymptomatic or undetected infections with SARS-CoV-2 - To assess the efficacy of Ad26.COV2.S in the prevention of SARS-CoV-2 infection Both Double-blind Phase and Open-label Active Surveillance Phase: - To evaluate safety in terms of SAEs, AESIs, MAAEs, and MAAEs leading to study discontinuation
Full list of secondary objectives (double-blind and open-label) are in Protocol |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
First occurrence of molecularly confirmed, moderate to severe/critical COVID-19, with onset at least 14 days after the second vaccination (Day 71) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Efficacy: First occurrence of molecularly confirmed, moderate to severe/critical COVID-19, with onset -1 day after the 1st vaccination -at least 14 days after the second vaccination (Day 71) -14 days after the 1st vaccination (Day 15) -28 days after the 1st vaccination (Day 29) Safety: Occurrence and relationship of SAEs and AESIs (during the entire study), MAAEs (until 6 months after the last vaccination including the open-label vaccination or booster vaccination, whichever comes last), and MAAEs leading to study discontinuation (during the entire study) for all participants Immunogenicity: -Analysis of antibodies binding to the SARS-CoV-2 S protein by ELISA -SARS-CoV-2 neutralization as measured by virus neutralization assay (VNA; wildtype virus and/or pseudovirion expressing SARS-CoV-2 S protein) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Efficacy: Day 2, day 15, day 29, day 71 Safety: throughout the study |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Brazil |
Colombia |
Philippines |
South Africa |
United States |
France |
Spain |
Germany |
Belgium |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |