Shaomin Chen, Zhifang Ying, Yan Liu, Yuan Li, Yebin Yu, Meilian Huang, Zhuhang Huang, Zhiqiang Ou, Yuyi Liao, Yong Zhang, Guixiu Liu, Weiwei Zhao, Rong Fu, Qiong Shou, Minghuan Zheng, Xueyan Liao, Yingmei Tu, Jon Stek, Jonathan Hartzel, Changgui Li, and Jikai Zhang
ABSTRACTThis open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three doses of an intramuscular, inactivated poliomyelitis vaccine (IPV) in 400 healthy infants. The primary objective was the non-inferiority of neutralizing antibody (nAb) responses in the concomitant- versus the staggered-use groups. Antibody responses were measured at baseline and 1-month post-dose 3 (PD3). Parents/legal guardians recorded adverse events for 30 or 15 d after study vaccinations in the concomitant-use or staggered-use groups, respectively. At PD3, >98% of participants seroconverted to all three poliovirus types, and the primary objective was met as lower bounds of the two-sided 95% CI for between-group difference in nAb seroconversion percentages ranged from − 4.3% to − 1.6%, for all poliovirus types, p