Fever was the most common adverse event, the pairwise comparison assessments showed no difference in the incidence rate of solicited, systemic or local adverse events. in the incidence rate of solicited, systemic or local adverse events. Three severe adverse events related to the vaccination were reported. Conclusions: The evidence of immunogenicity and security supports that this EV71 vaccine administered simultaneously with vaccines need to be administered during the same period of time recommended in China. (%)103 (47.69)103 (47.69)115 (53.24)104 (48.15)110 (50.93) Per-Protocol Populations No. of participant192129188193193Age, mean SD (months)6.53 0.026.57 0.038.56 0.028.56 0.027.56 0.08Male sex, (%)93 (48.44)59 (45.74)96 (51.06)89 (46.11)100 (51.81) Open in a separate windows Group A: EV71 vaccine and hepatitis B computer virus vaccine simultaneous administration group; Group B: EV71 vaccine and group A meningococcal polysaccharide vaccine simultaneous administration group; Group C: EV71 vaccine and measles-rubella combined vaccine simultaneous administration group; Group D: EV71 vaccine and Japanese encephalitis vaccine simultaneous administration group; Group E: EV71 vaccine separate administration group. Before vaccination, the seropositive rates of antibodies against EV71 were 19.79% (38/192), 18.60% (24/129), 5.85% (11/188), 8.29% (16/193), and 13.47% Garenoxacin (26/193) in Group A, Group B, Group C, Group D Garenoxacin and Group E, respectively, infants in Group C had lower seropositive rate (5.85% vs. 13.47%, = 0.012); the GMT of antibodies against EV71showed no difference between five groups. (Table 2). Table 2 Antibody responses to EV71 pre- and post-vaccination in the per-protocol populations. = 192)= 129)= 188)= 193)= 193)(%)38 (19.79)24 (18.60)11 (5.85)16 (8.29)26 (13.47) 0.000 0.0960.213 0.012 0.102(95% CI)(14.73C26.06)(12.77C26.31)(3.26C10.28)(5.13C13.13)(9.32C19.08)GMT5.065.174.304.614.850.052 (95% CI)(4.55C5.62)(4.61C5.79)(4.10C4.51)(4.16C5.11)(4.43C5.30) Post-Vaccination SPR, (%)191 Garenoxacin (99.48)124 (96.12)187 (99.47)192 (99.48)189 (97.93)0.055 (95% CI)(97.13C99.99)(91.19C98.73)(97.07C99.99)(97.15C99.99)(94.78C99.43)SCR, (%)189 (98.44)122 (94.57)187 (99.47)190 (98.45)189 (97.93)0.068 (95% CI)(95.50C99.68)(89.14C97.79)(97.07C99.99)(95.52C99.68)(94.78C99.43)GMT 792.51287.93680.91677.13562.47 0.000 0.007 0.000 0.1340.166(95% CI)(671.95C934.69)(228.66C362.56)(576.44C804.30)(562.35C815.35)(466.59C678.05) Open in a separate window * Adjusted 0.0125). (Table 2). Open in a separate window Figure 3 Differences in the proportion of seroconversion for simultaneous administration groups versus separate administration groups, China 2018 to 2019. Differences in the proportion of seroconversion were measured between simultaneous groups (Group A, Group B, Group C, and Group D) and separate group (Group E) with two-sided 95% CIs. We further analyzed the data of group E (Table 3). According to Figure 1 and Figure 2, the group E (= 193) was divided into four small groups, named group E1 (= 51), group E2 (= 45), group E3 (= 48) and group E4 (= 49) respectively. The seropositive rates and seroconversion rates of antibodies against EV71 showed no difference between the four small groups. There was a significant difference in the GMT of antibodies against EV71 for Group E1 (1004.00), Group E2 (341.06), Group E3 (553.35), and Group E4 (495.08). Furthermore, based on the pairwise comparison, there was a significant difference in GMT between Group E1 and Group E2 ( 0.0167). Table 3 Antibody responses to EV71 post- vaccination for group E in the per-protocol populations. = 51)= 45)= 48)= 49)(%)51 (100.00)43 (95.56)47 (97.92)48 (97.96)0.507 (95% CI)(93.02C100.00)(84.85C99.46)(88.93C99.95)(89.15C99.95)SCR, (%)51 (100.00)43 (95.56)47 (97.92)48 (97.96)0.507 (95% CI)(93.02C100.00)(84.85C99.46)(88.93C99.95)(89.15C99.95) GMT1004.00341.06553.35495.08 0.001 0.000 0.0870.177(95% CI)(738.13C1365.65)225.06C516.85)(377.46C811.22)(343.39C713.77) Open in a separate window * Adjusted value was 0.0167 (0.05/3). The safety evaluation Garenoxacin results including the incidence rate of solicited local and systemic AEs and GPX1 unsolicited AEs were shown in Table 4. The most common AEs consisted of fever, redness, and induration. The incidence rate of solicited AEs was 25.58% (55/215) in Group A, 29.63% (64/216) in Group B, 32.86% (70/213) in Group C, 40.47% (87/215) in Group D, and 32.41% (82/216) in Group E, showed a significant difference between five groups (= 0.019). Similarly, there was a significant difference in the incidence rate of solicited systemic AEs and fever between the five groups, the pairwise comparison tests showed no difference in the incidence rate of solicited AEs, solicited systemic AEs, and fever. Table 4 Reported adverse events after any vaccination. = 215)= 216)= 213)= 215)= 216)value was 0.0125 (0.05/4). No withdrawal or loss to follow-up due to vaccine-related AEs were observed among the infants who.