Efficacy and Safety of Two Doses of HIL-214 in Children

Summary

This is a randomized, placebo-controlled study that is being done to evaluate the safety and effectiveness of two doses of the HIL-214 vaccine compared to a placebo. The study will enroll 3000 children who will be 5 months of age at the time of the first dose study vaccine. The second dose of study vaccine will be given 28 days after the first dose.

Timeline

Start

2022-04-28

Primary completion

2023-12-28

Completion

2024-09-30

Outcome

Missed primary endpoint

Stopped: “Lack of efficacy”

registry analysis (superiority test); Placebo vs Experimental; Vaccine Efficacy 12.98 (95% CI -52.51 to 50.35) NCT05281094 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HIL-214	Vaccine	—	Intramuscular

Indications