CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Ad26.COV2.Sbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04765384
NCT04765384Phase 2Completed
CompareCT.gov

An Open-label, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants

Janssen Vaccines & Prevention B.V.·interventional·Posted Feb 21, 2021·Updated May 25, 2025

In Brief

A Phase 2 clinical trial evaluating Ad26.COV2.S for COVID-19 Prevention. Completed, enrolled 51 participants across 18 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19 Prevention
CountriesBrazil, South Africa, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 21, 2021
Enrollment StartAug 27, 2021
Primary CompletionNov 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.4 years ago

Interventions

Ad26.COV2.Sbiological

Participants will receive intramuscular (IM) injection of Ad26.COV2.S.