| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy Volunteers (Prevention of COVID-19 and influenza) |
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| E.1.1.1 | Medical condition in easily understood language |
| Healthy Volunteers (Prevention of COVID-19 and influenza) |
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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 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10059430 |
| E.1.2 | Term | Influenza immunization |
| E.1.2 | System Organ Class | 100000004865 |
|
| 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 |
1. To demonstrate the NI of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadrivalent standard-dose influenza vaccine administered alone.
2. To demonstrate the NI of the binding antibody after concomitant administration of Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of Ad26.COV2.S vaccine administered alone. |
|
| E.2.2 | Secondary objectives of the trial |
1.To assess safety and reactogenicity of a single dose of Ad26.COV2.S vaccine when administered separately or concomitantly with a seasonal
quadrivalent standard/high-dose influenza vaccine in participants aged 18/65 years and older
2.To assess the humoral immune response against the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S and a quadrivalent high-dose influenza vaccine vs the high-dose influenza vaccine alone, and of Ad26.COV2.S after concomitant administration versus alone
3.To assess the humoral response to SARS CoV-2 after the concomitant administration of Ad26.COV2.S and a seasonal quadrivalent standard/high-dose influenza vaccine versus the Ad26.COV2.S vaccine alone in naïve individuals
4.To compare seroconversion and assess seroprotection rates against the 4 influenza vaccine strains after the concomitant administration of Ad26.COV2.S and a seasonal quadrivalent influenza vaccine versus the seasonal quadrivalent influenza vaccine alone |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Participant is male or female aged ≥18 years of age, on the day of signing the ICF.
a. Groups 3 and 4 only: Participant is male or female aged ≥65 years of age, on the day of signing the ICF.
2. Participant must be healthy, in the investigator’s clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participants may have underlying illnesses, as long as the symptoms and signs are medically controlled.
3. Participant either received complete primary vaccination with an authorized/licensed COVID-19 vaccine (completed ≥6 months prior to the last vaccination against COVID-19) or is COVID-19 vaccine-naïve.
4. In the investigator’s clinical judgment, the participant may have a stable and well-controlled medical condition including comorbidities associated with an increased risk of progression to severe COVID-19) (including stable/well controlled HIV infection). If participants are on medication for a medical condition (including comorbidities associated with an increased risk of progression to severe COVID-19), the medication dose cannot have been modified within 4 weeks preceding vaccination. Participants will be included on the basis of relevant medical history at the investigator’s discretion.
5. Contraceptive (birth control) use by participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
Before randomization, participants who were born female must be either
a. Not of childbearing potential
b. Of childbearing potential and practicing a highly effective method of contraception and agrees to remain on such a method of contraception from signing the informed consent until 3 months after the administration of the last study vaccine. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first vaccination.
6. All participants who were born female and are of childbearing potential must:
a. Have a negative highly sensitive urine pregnancy test at screening
b. Have a negative highly sensitive urine pregnancy test on the day of vaccination prior to each study vaccine administration.
7. Participant agrees to not donate or receive bone marrow, blood, and blood products from the administration of the study vaccine until 3 months after receiving the study vaccines
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| E.4 | Principal exclusion criteria |
1. Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC (100.4°F) within 24 hours prior to the planned dose of study vaccine.
2. Participant has a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancies considered cured with minimal risk of recurrence per investigator’s clinical judgment).
3. Participant has a known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
4. Participant has a history of severe allergic reactions (eg, anaphylaxis) to any component of the seasonal quadrivalent influenza vaccines, including egg protein, or following a previous dose of any influenza vaccine.
5. Participant has an abnormal function of the immune system resulting from:
a. Clinical conditions (eg, autoimmune disease or immunodeficiency) are expected to have an impact on the immune response elicited by the study vaccine. Participants with autoimmune diseases (eg, autoimmune thyroiditis, autoimmune inflammatory rheumatic diseases such as rheumatoid arthritis and type 1 diabetes) that are stable and controlled without the use of systemic immunomodulators and glucocorticoids may be enrolled at the discretion of the investigator.
b. Chronic or recurrent use of systemic corticosteroids within 6 months before administration of the study vaccine and during the treatment period of the study at immunosuppressive doses. An immunosuppressive steroid dose is considered to be >20 mg prednisone or equivalent daily for 2 consecutive weeks.
c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 6 months before administration of the first study vaccine and during the treatment period of the study.
6. Participant has a history of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of febrile seizures during childhood.
7. Criterion deleted per Amendment 1.
8. Participant received treatment with immunoglobulins within 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) or blood products within 4 months before the administration of the first study vaccine or plans to receive such treatment during treatment period of the study.
9. Participant has history of TTS or heparin-induced thrombocytopenia and thrombosis (HITT).
10. Participant has history of capillary leak syndrome.
11. Participant received or plans to receive:
a. Licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccines.
b. Other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccines.
12. Participant received a licensed/registered SARS-CoV-2 vaccine less than 6 months prior to first study vaccination or during the course of this study (other than study vaccination)
13. Participant received vaccination with a seasonal influenza vaccine for the current influenza season in the Northern Hemisphere
14. Participant received an investigational drug (including any investigational agent for COVID-19 prophylaxis) or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the administration of the study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study
15. Participant is a woman who is pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the administration of the last study vaccine
16. Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
17. Participant had or plans to have major surgery (per the investigator’s judgment) within 4 weeks before the administration of the first study vaccine or will not have recovered from surgery at the time of vaccination
18. Participant has a contraindication to IM injections and blood draws (eg, bleeding disorders).
19. Participant has chronic active hepatitis B or hepatitis C infection per medical history.
20. Participant has had a major psychiatric illness or drug or alcohol abuse which in the investigator’s opinion would compromise the participant’s safety or compliance with the study procedures.
21. Participant has a positive diagnostic test result for current (viral RNA detection) SARS-CoV-2 infection prior to vaccine administration on Day 1
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| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Antibody hemagglutinin inhibition (HI) titers as measured by hemagglutinin inhibition assay (HAI) titers (geometric mean titers [GMTs]) against each of the 4 influenza vaccine strains at 28 days after the administration of a seasonal quadrivalent standard-dose influenza vaccine.
2. Antibody titers as measured by S enzyme-linked immunosorbent assay (S-ELISA) titers (geometric mean concentration [GMC]), 28 days after administration of Ad26.COV2.S vaccine. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| 28 days after vaccination |
|
| E.5.2 | Secondary end point(s) |
1. Solicited local (injection site) and systemic AEs for 7 days after each vaccination.
2. Unsolicited AEs for 28 days after each vaccination.
3. SAEs, MAAEs, and AESIs throughout the study.
4. AEs leading to withdrawal from the study throughout the study.
5. Antibody HI titers as measured by hemagglutinin inhibition (HAI) assay titers (GMTs) against each of the 4 influenza vaccine strains, 28 days after the administration of a seasonal quadrivalent standard-dose influenza vaccine.
6. Antibody titers as measured by S enzymelinked immunosorbent assay (S-ELISA) titers (GMC), 28 days after administration of Ad26.COV2.S
vaccine.
7. Antibody titers as measured by S-ELISA titers (GMC), 28 days after the administration of Ad26.COV2.S vaccine.
8. Seroconversion is defined for each of the 4 influenza vaccine strains at 28 days after the administration of a seasonal quadrivalent (high-dose
and standard dose) influenza vaccine:
- HI titer ≥1:40 in participants with a pre-vaccination HI titer of <1:10,
or
- a ≥4-fold HI titer increase in participants with a pre-vaccination HI titer of ≥1:10.
9. Seroprotection is defined for each of the 4 influenza vaccine strains as HI titer ≥1:40 at 28 days after the administration of a seasonal
quadrivalent (high-dose and standard-dose) influenza vaccine. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
- 7 and 28 days after vaccination
- SAEs, MAAEs, and AESIs throughout the study. |
|
| 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 | No |
| 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 | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
| Reactogenicity and Immunogenicity |
|
| 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 | 4 |
| 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 | 11 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 17 |
| 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 |
| United States |
| Poland |
| Belgium |
|
| E.8.7 | Trial has a data monitoring committee | No |
| 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 | |
| E.8.9.1 | In the Member State concerned months | 7 |
| E.8.9.1 | In the Member State concerned days | 15 |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
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