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

NCT04894305 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2021-12-22

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S (0.3 milliliter \[mL\] versus 0.5 mL) and to demonstrate non-inferiority (NI) of Ad26.COV2.S (0.3 mL versus 0.5 mL), 28 days after vaccination.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Ad26.COV2.S

Ad26.COV2.S will be administered as IM injection.

Sponsors & Collaborators

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2021-12-08
Completion
2021-12-08
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04894305 on ClinicalTrials.gov