COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05007080

Not reported

Not reported

2021-08-16

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: participant's age is 12 to 17 years of age at the time of first vaccination participant must be healthy, in the investigator's clinical judgement, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (covid-19) 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 participant and/or parent(s)/legal guardian(s) are available and willing to participate for the duration of the study visits and follow-up each participant or participant's parent(s)/legal guardian(s) must have access to a consistent means of contact either by telephone contact or email/computer

participant has a history of malignancy, bone marrow transplant, or solid organ transplant within 5 years before screening participant has a known or suspected allergy, history of anaphylaxis, or other serious adverse reactions, related to vaccines or their excipients (including specifically the excipients of the study vaccine) use of systemic corticosteroids at an immunosuppressive dose (treatment duration more than 14 days for one course or recurrent use) within 6 months before administration of study vaccine and during the study participants with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the participant if he/she participates in the study any serious, chronic, or progressive disease (example: diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, acquired immunodeficiency syndrome [aids] infection, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition)

6

Janssen Vaccines & Prevention B.V.

12

17

Argentina;Brazil;India;Mexico;South Africa

Healthy volunteers

N/A

304

Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2;Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1;Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2;Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1;Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2;Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1;Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2;Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2;Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Spike-enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days Post-dose 1;Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1;Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1;Groups 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C]);Groups 1, 2, and 3: Number of Participants With MAAEs Leading to Discontinuation;Groups 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs);Groups 4, 5 and 6: Number of Participants With AESI (Including MIS-C);Groups 4, 5 and 6: Number of Participants With MAAEs Leading to Discontinuation;Groups 4, 5 and 6: Number of Participants With Serious Adverse Events (SAEs);Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2

None

Phase 2

[{"arm_notes": "Group 1: Ad26.COV2.S Dose Level 1 (Lower Volume): 1-Dose Regimen", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 2: Ad26.COV2.S Dose Level 2: 1-Dose Regimen", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 3: Ad26.COV2.S Dose Level 3: 1-Dose Regimen", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 4: Ad26.COV2.S Dose Level 1: 2-Dose Regimen", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 5: Ad26.COV2.S Dose Level 2: 2-Dose Regimen", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Group 6: Ad26.COV2.S Dose Level 3: 2-Dose Regimen", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]