PMID- 35753838 OWN - NLM STAT- MEDLINE DCOM- 20220816 LR - 20220921 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 40 IP - 33 DP - 2022 Aug 5 TI - Immunogenicity and safety of the inactivated enterovirus 71 vaccine administered concomitantly with the measles-rubella vaccine in infants aged 8 months in China: A noninferiority randomized controlled trial. PG - 4709-4715 LID - S0264-410X(22)00776-9 [pii] LID - 10.1016/j.vaccine.2022.06.027 [doi] AB - BACKGROUND: To evaluate the immunogenicity and safety of simultaneous administration of the enterovirus 71 (EV71) vaccine with the measles and rubella (MR) combined vaccine. METHODS: In this phase 4, randomized, open-label and noninferiority study, a total of 680 infants aged 8 months were enrolled and assigned to the simultaneous administration group (infants received the first dose of EV71 vaccine and MR vaccine on Day 0, and the second dose of EV71 vaccine on Day 28), or the separate administration groups (EV71 group: infants received two doses of EV71 vaccine on Day 0 and Day 28, respectively; MR group: infants received MR vaccine on Day 0). Blood sample was obtained on Day 0 and Day 56 to measure antibody responses to each of the antigens in terms of antibody titer or concentration, respectively. Local and systemic adverse reactions (ARs) and other adverse events (AEs) following each dose were monitored and compared among groups. RESULTS: After vaccination, simultaneous administration group showed similar seroconversion rates of antibody against EV71(97.9%), measles (97.4%), and rubella (94.3%) compared to EV71 group (99.6% for anti-EV71) or MR group (98.4% for anti-measles and 98.9% for anti-rubella, respectively). Noninferiority was demonstrated for all antibodies as the lower limits of two-sided 97.5% confidence intervals (CIs) of the difference in seroconversion rates between simultaneous administration group and separate administration groups were above the predefined margin of -10%. Additionally, the adverse reaction rates were comparable among groups (54.4% in the simultaneous group versus 43.9% in the MR group versus 52.6% in the EV71 group). CONCLUSION: Antibody responses induced by simultaneous administration of EV71 vaccine with MR vaccine were robust and noninferior to those by single administration alone. Like the previous findings by single administration alone, simultaneous administration demonstrated comparable reactogenicity and safety profiles. CI - Copyright (c) 2022. Published by Elsevier Ltd. FAU - Zhao, Zhimei AU - Zhao Z AD - Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan 650118, China. FAU - Liao, Yuyi AU - Liao Y AD - Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong 510440, China. FAU - Li, Yuan AU - Li Y AD - Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong 510440, China; NMPA Key Laboratory for Technology Research and Evaluation of Pharmacovigilance, Guangzhou, Guangdong 510315, China. FAU - Jiang, Guorun AU - Jiang G AD - Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan 650118, China. FAU - Huang, Zhuhang AU - Huang Z AD - Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong 510440, China. FAU - Yang, Huijuan AU - Yang H AD - Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan 650118, China. FAU - Ou, Zhiqiang AU - Ou Z AD - Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong 510440, China. FAU - Yin, Qiongzhou AU - Yin Q AD - Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan 650118, China. FAU - Chen, Junhu AU - Chen J AD - Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong 510440, China. FAU - Deng, Yan AU - Deng Y AD - Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan 650118, China. FAU - Jiang, Ruiju AU - Jiang R AD - Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan 650118, China. FAU - Che, Yanchun AU - Che Y AD - Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan 650118, China. Electronic address: cheyanchun@imbcams.com.cn. FAU - Li, Qihan AU - Li Q AD - Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan 650118, China. Electronic address: liqihan@imbcams.com.cn. FAU - Zheng, Huizhen AU - Zheng H AD - Guangdong Provincial Center for Disease Control and Prevention, Guangzhou, Guangdong 511430, China. Electronic address: zhz@cdcp.org.cn. FAU - Zhang, Jikai AU - Zhang J AD - Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong 510440, China; NMPA Key Laboratory for Technology Research and Evaluation of Pharmacovigilance, Guangzhou, Guangdong 510315, China. Electronic address: gdswyw_sps@cdcp.org.cn. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20220624 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Viral) RN - 0 (Measles Vaccine) RN - 0 (Measles-Mumps-Rubella Vaccine) RN - 0 (Vaccines, Inactivated) SB - IM MH - Antibodies, Viral MH - *Enterovirus MH - *Enterovirus A, Human MH - Humans MH - Immunogenicity, Vaccine MH - Infant MH - *Measles/prevention & control MH - Measles Vaccine MH - Measles-Mumps-Rubella Vaccine MH - *Rubella/prevention & control MH - Vaccines, Inactivated OTO - NOTNLM OT - EV71 vaccine OT - Immunogenicity OT - Simultaneous administration COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2022/06/27 06:00 MHDA- 2022/08/17 06:00 CRDT- 2022/06/26 22:04 PHST- 2022/04/25 00:00 [received] PHST- 2022/06/02 00:00 [revised] PHST- 2022/06/07 00:00 [accepted] PHST- 2022/06/27 06:00 [pubmed] PHST- 2022/08/17 06:00 [medline] PHST- 2022/06/26 22:04 [entrez] AID - S0264-410X(22)00776-9 [pii] AID - 10.1016/j.vaccine.2022.06.027 [doi] PST - ppublish SO - Vaccine. 2022 Aug 5;40(33):4709-4715. doi: 10.1016/j.vaccine.2022.06.027. Epub 2022 Jun 24.