Valneva SE (VLA), a specialty vaccine company, and Pfizer Inc. (PFE) reported Tuesday positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15.
Based on these new results, the companies plan to proceed with inclusion of pediatric participants in their planned Phase 3 trial.
The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and above and is expected to be initiated in the third quarter of 2022, subject to regulatory approval.
The Phase 2 trial, VLA15-221, is the first clinical study with VLA15 which enrolled a pediatric population between 5 and 17 years old. It compared the immunogenicity and safety of VLA15 after administration of two or three primary series doses in groups aged 5-11, 12-17 and 18-65 years.
In pediatric participants who received VLA15 in either the two-dose schedule or three-dose schedule, VLA15 was found to be more immunogenic than in adults with both vaccination schedules tested.
Like in adults, the immunogenicity and safety data support a three-dose primary vaccination schedule in pediatric participants in the Phase 3 study.
The companies noted that the safety and tolerability profile observed in the 5- to 17-year age group was similar to the previously reported profile 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 a future scientific congress.
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