drugset / Trial / NCT04765384

A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)

NCT04765384

Phase 2 Completed 51 enrolled Janssen Vaccines & Prevention B.V.
NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule at the standard dose level in adult participants during the second and/or third trimester of pregnancy and (potentially) post-partum; to assess the humoral immune response in peripheral blood of adult participants to Ad26.COV2.S administered IM as a 1-dose schedule during the second and/or third trimester of pregnancy, 28 days after vaccination.

Timeline

Start
2021-08-27
Primary completion
2023-11-24
Completion
2023-11-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Ad26.COV2.S Vaccine Intramuscular

Indications

No indication recorded.