A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

开始日期2007-07-01

申办/合作机构-

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项与流感病毒裂解疫苗(Abbott Biologicals BV) 相关的文献（医药）

2007-12-01·Vaccine3区 · 医学

Antibody induction by virosomal, MF59-adjuvanted, or conventional influenza vaccines in the elderly

3区 · 医学

Article

作者: Jos Nauta ; Katinka Giezeman ; Iris de Bruijn ; Lisya Gerez ; Bram Palache ; Ingo Meyer

In a randomized, observer-blind, three-arm, parallel group, multi-centre trial including 386 elderly subjects in four countries, the immunogenicity and safety was studied of three different trivalent inactivated surface antigen (subunit) influenza vaccine types: a conventional subunit influenza vaccine (SIV, brand: Influvac and two newer vaccines: a MF59-adjuvanted subunit influenza vaccine (adSIV, brand: Fluad and a virosomal subunit influenza vaccine (vSIV, brand: Invivac. All vaccines were trivalent containing 15 microg hemagglutinin of each virus strain as recommended by the World Health Organization for the 2004-2005 season. The study was designed to demonstrate the serological non-inferiority of vSIV to both adSIV and SIV in elderly persons. The secondary objective was to investigate whether vSIV is superior to adSIV with respect to local reactogenicity. For all three vaccine strains, the post-vaccination geometric mean titres were comparable between SIV and adSIV and between vSIV and SIV. Seroprotection rates (i.e. percentages of subjects with a post-vaccination titre >or=40) varied between 84.1-100% indicating that the three vaccines all induced a strong antibody response. Local and systemic reactions were more frequently associated with adSIV (46 and 32%, respectively) than with vSIV or SIV ( approximately 20%). Vaccinations caused only little inconvenience as measured by questionnaire. In general, all vaccines were safe and well tolerated. In this trial, virosomal vaccine had similar immunogenicity to MF59-adjuvanted and conventional subunit vaccine and was considerably less reactogenic than the MF59-adjuvanted vaccine in the elderly.

1981-10-01·The Lancet1区 · 医学

HLA-RESTRICTED VIRUS-SPECIFIC CYTOTOXIC T-LYMPHOCYTE RESPONSES TO LIVE AND INACTIVATED INFLUENZA VACCINES

1区 · 医学

Article

作者: ChristopherW Potter ; Robert Pratt ; Diana Riley ; Qi Yi-Hua ; GeoffreyC Schild ; FrancisA Ennis ; AlainH Rook

36 young adult volunteers were given either virus, or inactivated surface-antigen influenza vaccine, containing influenza A (H1N1) antigen. Their peripheral-blood lymphocytes were analysed to determine whether cytotoxic T lymphocytes (CTL) were induced by these vaccines. All three vaccines induced HLA-restricted T-lymphocyte responses specific for influenza A virus. This CTL response was found in 28 of 30 volunteers who showed antibody responses and in 3 of 6 who did not develop antibodies. Virus infected target cells showing certain HLA antigens (A1, A9, and B8) were less susceptible to lysis by HLA-matched cytotoxic T effector cells than target cells which matched effectors at other HLA loci.

1979-06-01·Journal of Clinical Pathology3区 · 医学

Reactogenicity and immunogenicity of a surface-antigen-adsorbed influenza virus vaccine in children.

3区 · 医学

Article

作者: Milner, R D ; Jennings, R ; Potter, C W ; Eastwood, L M

An influenza virus vaccine containing the purified surface haemagglutinin and neuraminidase antigens of A/Victoria/75 and B/Hong Kong/73 viruses adsorbed to an aluminium hydroxide gel was assessed for reactogenicity and immunogenicity in children aged 4 to 11 years, since there is no influenza virus vaccine available for this age group. Significant serum haemagglutination-inhibiting antibody responses to the A/Victoria/75 and B/Hong Kong/73 haemagglutinin antigens present in the vaccine were observed in 47% and 35%, respectively, of the children vaccinated, with a single dose. The vaccine induced no significant local or systemic reactions.

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