COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04765384

Not reported

Not reported

2021-02-21

Completed

nonRCT

Non-randomized

Single group assignment

Open label

multi-center

Prevention

inclusion criteria: if on medication for a condition, the medication dose must have been stable for at least 4 weeks preceding vaccination participant must be healthy as confirmed by medical history, physical examination, vital signs, and obstetric history performed at screening. participant may have underlying illnesses, as long as the symptoms and signs are medically controlled participant will be at second or third trimester of pregnancy, that is, week 16 to week 38 of gestation (inclusive), at the time of vaccination, based on ultrasound at the time of screening (or not longer than 10 days prior to vaccination if performed elsewhere) 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 must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study participant either received their last covid-19 vaccination with an authorized/licensed covid-19 vaccine (at least 4 months prior to first study vaccination) or is covid 19 vaccine-naïve

participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy) participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence) participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood participant has a positive diagnostic test result (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between) participant has a history of thrombosis with thrombocytopenia syndrome (tts), including cerebral venous sinus thrombosis (cvst), or heparin-induced thrombocytopenia (hit) participant has a history of capillary leak syndrome (cls)

1

Janssen Vaccines & Prevention B.V.

18

45

Brazil;South Africa;United States

High risk patients

N/A

98

Number of Participants with Adverse Events of Special Interest (AESIs);Number of Participants with AEs leading to Discontinuation;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination or Until Resolution;Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination or Until Resolution;Number of Participants with Unsolicited AEs;Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After Vaccination

None

Phase 2

[{"arm_notes": "nan", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]