Key result
Co-administration of EV71 vaccine with MMR and LA-JEV was non-inferior to EV71 vaccine alone for EV71 neutralizing antibody seroconversion (97.27% vs 97.32%; difference -0.05%, 95% CI -5.38 to 5.21).
Why the study?
Co-administration of vaccines could increase uptake and reduce clinic visits, but the immunogenicity and safety of EV71 vaccine co-administered with MMR and LA-JEV needed evaluation.
Does co-administration of EV71 vaccine with MMR and LA-JEV maintain immunogenicity and safety compared to separate administration in healthy infants?
RCT (n=372)
1:1:1 ratio
No
Does co-administration of EV71 vaccine with MMR and LA-JEV maintain immunogenicity and safety compared to separate administration in healthy infants?
Mean Difference: -0.05 (95% CI -5.38–5.21)
Absolute Event Rate: 97.27% vs 97.32%
Co-administration of the EV71 vaccine with MMR and LA-JEV in infants is safe and does not interfere with the immune response to any of the vaccines.
Supports co-administration in pediatric schedules; extends RCT evidence on multi-vaccine compatibility.
Co-administration of vaccines could be an efficient strategy to increase vaccination uptake and reduce the number of clinic visits. This randomized controlled study aimed to evaluate the immunogenicity and safety of enterovirus 71 (EV71) vaccine co-administered with measles-mumps-rubella (MMR) vaccine and live-attenuated Japanese encephalitis vaccine (LA-JEV). A total of 372 healthy infants were randomly assigned in a 1:1:1 ratio to receive simultaneous administration of EV71 vaccine (dose 1) and MMR on d 0 and EV71 vaccine (dose 2) and LA-JEV on d 30 (Group 1); administration of MMR and LA-JEV on d 0 and 30, respectively (Group 2); or administration of doses 1 and 2 of EV71 vaccine on d 0 and 30, respectively (Group 3). The non-inferiority analysis of the seroconversion for EV71 neutralizing antibody after vaccination was the primary outcome. According to per protocol set, antibody response against EV71, measles, mumps, rubella, and Japanese encephalitis (JE) virus was similar regardless of administration schedule. After vaccination, the seroconversion rate of EV71 neutralizing antibody in Group 1 (107 [97.27%] of 110) was non-inferior to that in Group 3 (109 [97.32%] of 112; difference - 0.05% [95% CI - 5.38 to 5.21]). The incidences of adverse reactions were 62.60% (77/123) in Group 1, 54.84% (68/124) in Group 2, and 37.70% (46/122) in Group 3, and most of them were mild to moderate in severity. No vaccine-related serious adverse events were reported. In total, the co-administration of combined EV71 vaccine with MMR and LA-JEV showed no interference with antibody response and demonstrated good safety profiles.
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Liu et al. (2021) conducted an RCT in Healthy infants (n=372). EV71 vaccine co-administered with MMR and LA-JEV vs. EV71 vaccine alone or MMR and LA-JEV alone was evaluated on seroconversion for EV71 neutralizing antibody after vaccination (difference -0.05%, 95% CI -5.38 to 5.21). Co-administration of EV71 vaccine with MMR and LA-JEV was non-inferior to EV71 vaccine alone for EV71 neutralizing antibody seroconversion (97.27% vs 97.32%; difference -0.05%, 95% CI -5.38 to 5.21).
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