[Source: Journal of Infectious Diseases, full page: (LINK). Abstract, edited.]
Immunogenicity and safety of an inactivated enterovirus 71 vaccine administered simultaneously with recombinant hepatitis B vaccine and group A meningococcal polysaccharide vaccine: a phase IV, open-label, single-center, randomized, non-inferiority trial
Zewu Zhang, MS, Zhenglun Liang, PhD, Ji Zeng, MS, Jikai Zhang, MS, Peng He, MS, Jiali Su, MS, Yaoming Zeng, BS, Renfeng Fan, MS, Dan Zhao, BS, Wenjun Ma, MS, Gang Zeng, PhD, Qiaoli Zhang, MS, Huizhen Zheng, BS
The Journal of Infectious Diseases, jiz129, https://doi.org/10.1093/infdis/jiz129
Published: 19 March 2019
This study tested the hypothesis that the immunogenicity and safety of the simultaneous administration of the combined EV71 vaccine with recombinant hepatitis B vaccine (HepB) and group A meningococcal polysaccharide vaccine (MenA) is not inferior to separate administration of each vaccine.
The study was designed as a randomized, open-label, and non-inferiority trial, and was registered at ClinicalTrials.gov (NCT03274102). A total of 775 healthy infants aged 6 months were randomized 1:1:1 to simultaneous administration (SI) or separate administration (SE1:EV71 and SE2: HepB followed by MenA).
According to per protocol set, antibody response against EV71, hepatitis B virus and group A meningococcal polysaccharide was similar regardless of administration schedule. With the non-inferiority margin set at 10%, the seroconversion of the three pathogens in the SI group (100% [98.25, 100], 44.84% [38.20, 51.63] and 27.83% [21.91, 34.38]) was not inferior to that of SE1 or SE2 group (100% [98.31, 100], 44.35% [37.82, 51.02] and 29.17% [23.20, 35.72]). The occurrences of adverse reactions of each vaccination regimen were comparable (60.62% vs 52.33% and 56.98%, P = 0.16).
Simultaneous administration of combined EV71 vaccine with HepB and MenA shows non inferiority in immunogenicity and safety compared with separate administration.
Clinical Trial Registration NCT03274102
simultaneous administration, EV71 vaccine, phase-IV trial
Issue Section: Major Article
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Keywords: Enterovirus; EV-71; Vaccines.