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Valneva and Pfizer Report Positive Pediatric Phase 2 Data for Lyme Disease Vaccine Candidate, VLA15

(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.

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