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A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents

NCT04535453 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 635

Last updated 2023-06-22

Study results available
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Summary

The primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination; safety and reactogenicity of Ad26.COV2.S administered IM as a 2-dose or a single-dose schedule in adults (18-65 years or older) and to assess the safety and reactogenicity of Ad26.COV2.S, administered IM as single dose in adolescents (12-17 years) and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart) in adults (18-55 years and 65 years or older).

Conditions

  • Healthy

Interventions

BIOLOGICAL

Ad26.COV2.S

All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.

OTHER

Placebo

Adult participants in Groups 4, 5, 6, 8, and 10, and adolescent participants in Group C will receive at least one injection of placebo.

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
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2022-03-09
Completion
2022-03-09
FDA Drug
Yes

Countries

  • Germany
  • Netherlands
  • Spain
  • United Kingdom

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 NCT04535453 on ClinicalTrials.gov