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  • Pfizer pulls 50% of people from phase 3 Lyme disease study for GCP violations at US trial sites – Fierce Biotech
Saturday, 18 February, 2023

Pfizer pulls 50% of people from phase 3 Lyme disease study for GCP violations at US trial sites – Fierce Biotech

Pfizer and Valneva’s phase 3 Lyme disease vaccine clinical trial has gone badly wrong. After discovering good clinical practice (GCP) violations at some trial sites, the partners have removed around half of the enrolled participants from the study.

The clinical trial got underway in August with the goal of enrolling around 18,000 healthy people who live in areas with endemic Lyme disease and lead lifestyles that put them at increased risk of being bitten by ticks. Participants are receiving either VLA15 or placebo to assess the ability of the multivalent protein subunit vaccine to reduce the risk of catching Lyme disease.

Read more at: https://www.fiercebiotech.com/biotech/pfizer-pulls-50-people-phase-3-trial-gcp-violations

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