Valneva Commences Recruitment Of Adolescents Into Phase 3 Trial On COVID-19 Vaccine

(RTTNews) - Valneva SE (VALN) said that it has commenced recruitment of adolescents in its pivotal Phase 3 Clinical Trial (VLA2001-301) for its inactivated COVID-19 vaccine candidate VLA2001 in the United Kingdom.

Results from the trial are expected early in the fourth quarter of 2021 and are intended to form the basis for potential regulatory approval in adults.

The company has also started to provide boosters to volunteers in its Phase 1/2 VLA2001-201 trial.

An initial cohort of adolescents will be enrolled in an open label, non-randomized format. Subject to safety review, remaining participants will be randomized to receive two doses of either VLA2001 or a placebo 28 days apart, followed by a booster dose seven months after enrolling into the study.

Approximately 660 participants will be recruited for this trial. Participants randomized to the placebo arm will have the opportunity to receive a course of VLA2001 following the initial safety assessment.

A further expansion of the study to include volunteers younger than 12 years old is also envisaged, subject to data from the adolescent group.

Valneva has also commenced booster vaccinations as a continuation of the Phase 1/2 VLA2001-201 trial for which the Company reported positive topline data in April 2021. The booster shot will be provided to each volunteer six months after initial vaccination.

Valneva said it is conducting several clinical trials of VLA2001. In addition to Cov-Compare and VLA2001-201, VLA2001 is being evaluated in elderly volunteers in study VLA2001-304 in New Zealand as well as in a small, policy-led trial sponsored by University Hospital Southampton NHS Foundation Trust which is not part of Valneva's regulatory package.

The company noted that it continues discussions with the European Commission regarding a potential VLA2001 supply contract.