At a glance
ClinicalIndex Comparison Record- ✓Adults aged 18 to 55 years inclusive, or 65 years or older
- ✓Adults 18-55 must be healthy with no comorbidities related to increased risk of severe COVID-19, except smoking and mild hypertension allowed; adults 65+ may have underlying illnesses if medically controlled and not related to severe COVID-19 risk, except smoking and mild hypertension allowed
- ✓BMI less than 30.0 kg/m²
- ✓Negative urine pregnancy test at screening and before each vaccine dose for participants of childbearing potential
- ✕Clinically significant acute illness or temperature ≥38.0°C within 24 hours prior to planned first dose
- ✕History of malignancy within 5 years before screening, except squamous and basal cell skin carcinomas or cervical carcinoma in situ, or cured malignancy with minimal recurrence risk
- ✕Known or suspected allergy or history of anaphylaxis to vaccines or their excipients, including study vaccine excipients
- ✕Immunoglobulin treatment within 3 months or blood products within 4 months before planned first dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive
In Brief
A Phase 2 clinical trial evaluating Ad26.COV2.S and Placebo for Healthy. Completed, enrolled 635 participants across 13 sites in 4 countries.
Detailed 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).
Study Details
Timeline
Interventions
All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.
Adult participants in Groups 4, 5, 6, 8, and 10, and adolescent participants in Group C will receive at least one injection of placebo.