Dataset from A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection Due to RSV

The purpose of this two-part designed study is to assess in the setting of a planned early
interception of pediatric RSV disease, early viral and disease kinetics (observational stage)
and the antiviral effects of an Respiratory Syncytial Virus (RSV) fusion inhibitor,
JNJ-53718678 (interventional stage). In the observational stage the infant is closely
monitored for early symptoms by the parent(s)/caregiver(s) and thus may be brought in for
diagnosis earlier than in the typical setting.