(RTTNews) – Valneva SE (VLA), a vaccine company, and Pfizer Inc. (PFE) on Tuesday announced positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15.
Based on these new results, the companies plan to proceed with enrolling pediatric participants in their planned Phase 3 trial.
The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and older and is expected to be initiated in the third quarter of 2022, pending regulatory approval.
The Phase 2 trial, VLA15-221, is the first clinical study with VLA15 that has enrolled a pediatric population between 5 and 17 years old. It compared the immunogenicity and safety of VLA15 after administration of two or three doses of the primary series in groups aged 5 to 11 years, 12 to 17 years and 18 to 65 years.
In pediatric participants who received VLA15 using either the two-dose schedule or the three-dose schedule, VLA15 was found to be more immunogenic than in adults with both vaccination schedules tested.
As in adults, immunogenicity and safety data support a three-dose primary schedule in pediatric participants in the Phase 3 study.
The companies noted that the safety and tolerability profile seen in the 5-17 year age group was similar to the profile previously reported in adult participants. No vaccine-related serious adverse events or SAEs were observed.
Valneva and Pfizer plan to submit these data for publication and presentation at an upcoming scientific meeting.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.