At a glance
ClinicalIndex Comparison Record- ✓RSV-seronegative status documented within 42 days prior to dosing
- ✓Born at ≥37 weeks gestation with birth weight ≥2.5 kg
- ✓Good health without significant medical illness on physical exam, history, and vital signs
- ✓Up-to-date with all routine age-appropriate immunizations per local guidelines
- ✕Weight below tenth percentile on WHO pediatric growth charts
- ✕History of seizure disorders, bleeding/clotting disorders, autoimmune disease, active malignancy, or systemic infections
- ✕Congenital heart disease or significant pulmonary conditions (asthma, cystic fibrosis, bronchopulmonary dysplasia, history of wheezing requiring treatment, hospitalization/mechanical ventilation for respiratory illness)
- ✕Known or suspected immunodeficiency including HIV infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled, Observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers 12 to 24 Months of Age
In Brief
A Phase 2 clinical trial evaluating Ad26.RSV.preF, Placebo, and 1 other intervention for Respiratory Syncytial Virus. Completed, enrolled 38 participants across 25 sites in 8 countries.
Detailed Summary
The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5\*10\^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.
Study Details
Timeline
Interventions
Ad26.RSV.preF will be administered as IM injection at a dose of 2.5\*10\^10 vp.
Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.
Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.