A phase 3, randomized, open-label, multi-country study to evaluate the immunogenicity, safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and different revaccination schedules in adults aged 60 years and above.

Respiratory Syncytial Virus Infections

Humoral immune response at pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), and at 6 and 12 months post-Dose 1 (Months 6 and 12), in a subset of participants: Neutralizing titers against RSV-A. Neutralizing titers against RSV-B.

Humoral immune response at pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), and at 6 and 12 months post-Dose 1 (Months 6 and 12), in a subset of participants: RSVPreF3-binding Immunoglobulin G (IgG) antibody concentrations., Humoral immune response at Months 18, 24, 30, 36, 42, 48, 54 and 60 post-Dose 1, and at 1 month after each revaccination dose (Months 13, 25, 37 and 49), in a subset of participants: Neutralizing titers against RSV-A and RSV-B RSVPreF3-binding IgG antibody concentrations., CMI response at pre-vaccination (Day 1), 30 days post Dose 1 (Day 31), at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 post-Dose 1, and after each revaccination dose (Months 13, 25, 37, 49, 61, 66 and 72), in a subset of participants: Frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-, IFN-, IL-13, IL-17., • Occurrence of each solic. admin. site + systemic event during a 4-day Fup period (i.e., on the day of vaccination and 3 subsequent days) after each vaccination. • Occurrence of any unsolic. AE during a 30-day Fup period (i.e., on the day of vaccination and 29 subsequent days) after each vaccination. • Occurrence of all SAEs and pIMDs up to 6 months after each vaccination. • Occurrence of fatal SAEs, related SAEs and related pIMDs from first vaccination (D1) up to study end (M72).

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Finland, Germany