COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05091307

Not reported

Not reported

2021-10-25

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: 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 participant either received complete primary vaccination with an authorized/licensed coronavirus disease-2019 (covid-19) vaccine (completed greater than or equal to [>=] 6 months prior to the last vaccination received against covid-19) or is covid-19 vaccine-naive 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 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 participant must be willing to provide verifiable identification to be contacted and to contact the investigator during the study

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) participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature >= 38.0 degrees celsius (ºc) (100.4 degrees fahrenheit [°f]) within 24 hours prior to the planned dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator participant has history of thrombosis with thrombocytopenia syndrome (tts) or heparin-induced thrombocytopenia and thrombosis (hitt) participant has history of capillary leak syndrome participant received a licensed/registered severe acute respiratory syndrome coronavirus(-2) (sars-cov-2) vaccine less than 6 months prior to first study vaccination (other than study vaccination) participant has a history of any neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood

4

Janssen Vaccines & Prevention B.V.

18

100

Belgium;Poland;United States

Healthy volunteers

N/A

861

Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Antibodies Measured by Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) 28 Days After Administration of Ad26.COV2.S Vaccine;Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine

None

Phase 3

[{"arm_notes": "Concomitant dose on Day 1 (flu standard dose + Ad26.COV2.S IM) + and placebo on Day 29;18-64 years old", "treatment_id": 2010, "treatment_name": "Ad26.cov2.s+flu vaccine", "treatment_type": "Non replicating viral vector+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "(Flu standard dose+placebo) on day 1 + Ad26.COV2.S IM on day 29;18-64 years old", "treatment_id": 2010, "treatment_name": "Ad26.cov2.s+flu vaccine", "treatment_type": "Non replicating viral vector+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Concomitant dose on Day 1 (flu high dose + Ad26.COV2.S IM) + and placebo on Day 29;>65 years old", "treatment_id": 2010, "treatment_name": "Ad26.cov2.s+flu vaccine", "treatment_type": "Non replicating viral vector+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "(Flu high dose+placebo) on day 1 + Ad26.COV2.S IM on day 29;>65 years old", "treatment_id": 2010, "treatment_name": "Ad26.cov2.s+flu vaccine", "treatment_type": "Non replicating viral vector+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}]