A Phase 2b, non-randomized, controlled, open-label, extension study to evaluate the persistence of immune response of the adjuvanted RSVPreF3 vaccine and the safety and immunogenicity following revaccination in lung and kidney transplant recipients (≥18 years of age)

Respiratory Syncytial Virus Infections

•RSV-A and RSV-B serum neutralizing titers expressed as GMT at Visit 1 in IC-1 and IC-2 groups. •RSV-A and RSV-B serum neutralizing titers expressed as MGI at Visit 1 in the current study over 30 days post last dose in the parent study in IC-1 and IC-2 groups. •RSV-A and RSV-B serum neutralizing titers expressed as GMT in IC-1 and IC-2 groups at Visit 2 and Visit 3.

•RSV-A and RSV-B serum neutralizing titers expressed as group GMT ratio IC-2 over IC-1 at Visit 1., •RSV-A and RSV-B serum neutralizing titers expressed as MGI at Visit 2 and Visit 3 over Visit 1 in IC-1 and IC-2 groups., •RSV-A and RSV-B serum neutralizing titers expressed as MGI at Visit 2 in the RSV-031 study over 30 days post last dose in the parent study in IC-1 and IC-2 groups., Percentage of participants reporting: - each solicited administration site event with onset within 7 days after receiving the re-vaccination dose - each solicited systemic event with onset within 7 days after receiving the re-vaccination dose • unsolicited AEs within 30 days after receiving the re-vaccination dose • any SAEs and pIMDs after receiving the re-vaccination dose up to Month 6 • related SAEs and related pIMDs after receiving the re-vaccination dose up to study end, Percentage of participants reporting: -fatal SAEs after receiving the re-vaccination dose of the adjuvanted RSVPreF3 vaccine up to study end -AESIs, specific to kidney and lung SOT patients, after receiving the re-vaccination dose up to study end

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Germany, Italy, Spain