COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003953-43/PL

Janssen Research & Development - Clinical Registry Group

ClinicalTrialsEU@its.jnj.com

2021-09-01

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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

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

4

Janssen Vaccines & Prevention B.V.

18

100

Belgium;Poland;United States;Netherlands

Healthy volunteers

N/A

225

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.

Declared number of arm (5.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Quadrivalent Afluria", "treatment_id": 627, "treatment_name": "Quadrivalent inactivated influenza vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "Fluzone \u00e0 haute dose", "treatment_id": 627, "treatment_name": "Quadrivalent inactivated influenza vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]