(Alliance News) - GlaxoSmithKline PLC on Tuesday said patient dosing has begun in a phase III clinical programme investigating the immunogenicity, safety, reactogenicity and persistence of its respiratory syncytial virus candidate vaccine for older adults.
The move follows the release of positive phase I/II results on safety, reactogenicity and immunogenicity.
The respiratory syncytial virus candidate vaccine for older adults contains a recombinant subunit pre-fusion respiratory syncytial virus antigen combined with GSK's proprietary AS01 adjuvant. The vaccine candidate has shown promising safety and immunogenicity in a phase I/II study in both young and older adults and was well-tolerated.
The Brentford, London-headquartered pharmaceutical company said respiratory syncytial virus represents a significant health threat for older adults, who are 60 years of age and older. GSK said a respiratory syncytial virus vaccine for older adults would help prevent primary infection and also help preserve independence, health and quality of life.
"With our unique combination of technologies, the pre-fusion F antigen and our proprietary adjuvant system, we were able to induce a strong immune response, of both humoral and cellular components, to levels normally seen in healthy adults," said Emmanuel Hanon, senior vice president & head of Vaccines Research & Development for GSK.
GSK shares were trading 0.4% lower in London on Tuesday at 1,282.40 pence each.
By Evelina Grecenko; evelinagrecenko@alliancenews.com
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Glaxosmithkline (GSK)