This sequential, observer-blind, randomised, single-centre, combined Phase I and Phase II clinical trial compared the tolerability and immunogenicity of a single intramuscular dose of a novel cell-culturederived influenza vaccine (CCIV), produced in Madin–Darby canine kidney cells, with a conventional egg-based vaccine. The immunogenicity of both vaccines was assessed by SRH assay, a well-recognized test byEMEA, incompliance with the requirements of theEUCommittee forMedicinal Products forHuman Use (CHMP). The Phase I part of the trial comprised 40 healthy adults (18–40 years of age); the subsequent Phase II part involved 200 healthy adult (n = 80, 18–60 years of age) and elderly (n = 120, ≥61 years of age) subjects. Both vaccines showed similar reactogenicity and any solicited local or systemic reactions were mostly mild or moderate. Regarding immunogenicity, both the CCIV and the control vaccine met all of the EU Committee forMedicinal Products for Human Use criteria for influenza vaccines for each strain and in both age groups. In conclusion, the CCIV produced in mammalian cell-culture is as well tolerated and as immunogenic as the control egg-based vaccine in non-elderly and elderly adults.

Groth, N., Montomoli, E., Gentile, C., Manini, I., Bugarini, R., Podda, A. (2009). Safety, tolerability and immunogenicity of a mammalian cell culture-derived influenza vaccine: a sequential Phase I and Phase II clinical trial. VACCINE, 27(5), 786-791 [10.1016/j.vaccine.2008.11.003].

Safety, tolerability and immunogenicity of a mammalian cell culture-derived influenza vaccine: a sequential Phase I and Phase II clinical trial

MONTOMOLI, E.;GENTILE, C.;MANINI, I.;
2009-01-01

Abstract

This sequential, observer-blind, randomised, single-centre, combined Phase I and Phase II clinical trial compared the tolerability and immunogenicity of a single intramuscular dose of a novel cell-culturederived influenza vaccine (CCIV), produced in Madin–Darby canine kidney cells, with a conventional egg-based vaccine. The immunogenicity of both vaccines was assessed by SRH assay, a well-recognized test byEMEA, incompliance with the requirements of theEUCommittee forMedicinal Products forHuman Use (CHMP). The Phase I part of the trial comprised 40 healthy adults (18–40 years of age); the subsequent Phase II part involved 200 healthy adult (n = 80, 18–60 years of age) and elderly (n = 120, ≥61 years of age) subjects. Both vaccines showed similar reactogenicity and any solicited local or systemic reactions were mostly mild or moderate. Regarding immunogenicity, both the CCIV and the control vaccine met all of the EU Committee forMedicinal Products for Human Use criteria for influenza vaccines for each strain and in both age groups. In conclusion, the CCIV produced in mammalian cell-culture is as well tolerated and as immunogenic as the control egg-based vaccine in non-elderly and elderly adults.
2009
Groth, N., Montomoli, E., Gentile, C., Manini, I., Bugarini, R., Podda, A. (2009). Safety, tolerability and immunogenicity of a mammalian cell culture-derived influenza vaccine: a sequential Phase I and Phase II clinical trial. VACCINE, 27(5), 786-791 [10.1016/j.vaccine.2008.11.003].
File in questo prodotto:
File Dimensione Formato  
014-2009_VACC-Groth.pdf

non disponibili

Tipologia: Abstract
Licenza: NON PUBBLICO - Accesso privato/ristretto
Dimensione 371.24 kB
Formato Adobe PDF
371.24 kB Adobe PDF   Visualizza/Apri   Richiedi una copia

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11365/43310
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo