BACKGROUND: This study assessed the safety, reactogenicity, and immunogenicity of an injectable cell culture-derived influenza vaccine (CCIV), compared with those of an injectable egg-based trivalent inactivated influenza vaccine (TIV). METHODS:Adult subjects (n = 613; 18 to <50 years of age) were randomized (1:1) to receive either CCIV or TIV. The safety and reactogenicity of the 2 vaccines were assessed on the basis of solicited indicators and other adverse events (AEs) within 7 days of vaccination. All serious AEs and those AEs resulting in withdrawal were recorded throughout the study. Antibody titers were determined by the hemagglutination inhibition assay, using egg- and cell-derived antigens. Immunogenicity was assessed on the basis of the ratio of postvaccination (day 22) geometric mean titers (GMTs) between the 2 vaccines, seroprotection rates, and seroconversion rates. RESULTS: There was no clinically relevant difference between the safety and reactogenicity profiles of the 2 vaccines. The immunogenicity of CCIV was demonstrated to be noninferior to that of TIV on the basis of the ratio of postvaccination GMTs between the 2 vaccines. GMTs, seroprotection rates, and seroconversion rates were comparable between the 2 vaccines. CONCLUSIONS: The safety, reactogenicity, and immunogenicity of the CCIV and the egg-based TIV are comparable.
RCT Entities:
BACKGROUND: This study assessed the safety, reactogenicity, and immunogenicity of an injectable cell culture-derived influenza vaccine (CCIV), compared with those of an injectable egg-based trivalent inactivated influenza vaccine (TIV). METHODS: Adult subjects (n = 613; 18 to <50 years of age) were randomized (1:1) to receive either CCIV or TIV. The safety and reactogenicity of the 2 vaccines were assessed on the basis of solicited indicators and other adverse events (AEs) within 7 days of vaccination. All serious AEs and those AEs resulting in withdrawal were recorded throughout the study. Antibody titers were determined by the hemagglutination inhibition assay, using egg- and cell-derived antigens. Immunogenicity was assessed on the basis of the ratio of postvaccination (day 22) geometric mean titers (GMTs) between the 2 vaccines, seroprotection rates, and seroconversion rates. RESULTS: There was no clinically relevant difference between the safety and reactogenicity profiles of the 2 vaccines. The immunogenicity of CCIV was demonstrated to be noninferior to that of TIV on the basis of the ratio of postvaccination GMTs between the 2 vaccines. GMTs, seroprotection rates, and seroconversion rates were comparable between the 2 vaccines. CONCLUSIONS: The safety, reactogenicity, and immunogenicity of the CCIV and the egg-based TIV are comparable.
Authors: Byoung-Shik Shim; Jung-Ah Choi; Ho-Hyun Song; Sung-Moo Park; In Su Cheon; Ji-Eun Jang; Sun Je Woo; Chung Hwan Cho; Min-Suk Song; Hyemi Kim; Kyung Joo Song; Jae Myun Lee; Suhng Wook Kim; Dae Sub Song; Young Ki Choi; Jae-Ouk Kim; Huan Huu Nguyen; Dong Wook Kim; Young Yil Bahk; Cheol-Heui Yun; Man Ki Song Journal: J Microbiol Date: 2013-03-02 Impact factor: 3.422
Authors: Mario M Alvarez; Felipe López-Pacheco; José M Aguilar-Yañez; Roberto Portillo-Lara; Gonzalo I Mendoza-Ochoa; Sergio García-Echauri; Pamela Freiden; Stacey Schultz-Cherry; Manuel I Zertuche-Guerra; David Bulnes-Abundis; Johari Salgado-Gallegos; Leticia Elizondo-Montemayor; Martín Hernández-Torre Journal: PLoS One Date: 2010-04-14 Impact factor: 3.240