19th Aug 2020 10:34
(Alliance News) - GlaxoSmithKline PLC on Wednesday said it has vaccinated the first participant in phase 3 clinical trials of its 5-in-1 meningitis vaccine candidate.
The study will evaluate the safety, tolerability and immunogenicity - the latter meaning the ability of the vaccine to cause an immune response - of Glaxo's MenABCWY vaccine candidate compared to licensed vaccines Bexsero and Menveo.
Since the 2010 approval of Menveo, FTSE 100-listed Glaxo's vaccine for meningococcal groups A,C, Y, and W-135, the company has distributed over 58 million doses. Glaxo has also distributed over 52 million doses of meningococcal group B vaccine, Bexsero, since its approval in 2013.
Initial phase 3 studies will take place in individuals aged between 10 and 25 in the US, Europe, Turkey, and Australia and the study investigators will enrol 3,650 participants.
If the trial of MenABCWY is successful, it could mean fewer injections for children and young adults in order to protect them from invasive meningococcal disease as just five meningitis subgroups, A, C, W, Y and B, make up almost all IMD cases and there is currently no 5-in-1 combination available.
Emmanuel Hanon, senior vice president & head of Vaccines R&D at Glaxo, said: "Entering the final stage of clinical trials with our 5-in-1, MenABCWY vaccine candidate is a major step toward GSK's goal of reducing meningococcal disease around the world. This vaccine candidate builds on the heritage of Bexsero and Menveo and we would like to thank all the scientific researchers, medical partners, advocates and families around the world who also hope for a successful outcome."
Shares in Brentford, London-headquartered Glaxo were up 0.5% at 1,546.40 pence in London on Wednesday morning.
By Anna Farley; [email protected]
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