Key result
Co-administering sIPV booster with MMRV or HepA matches separate dosing for seroconversion.
Why the study?
It was unknown whether an sIPV booster given concomitantly with MMRV or HepA is non-inferior in immunogenicity and comparable in safety to separate administration at the 18-month visit.
Does concomitant administration of sIPV with MMRV or HepA maintain non-inferior immunogenicity and comparable safety compared to separate administration in healthy children aged 18-22 months?
RCT (n=889)
Open-label
2:2:2:1:1
Does concomitant administration of sIPV with MMRV or HepA maintain non-inferior immunogenicity and comparable safety compared to separate administration in healthy children aged 18-22 months?
Same-day co-administration of sIPV with MMRV or HepA is non-inferior in immunogenicity and well tolerated compared to separate administration, supporting programmatic adoption.
Supports concomitant sIPV booster with MMRV or HepA at 18 months; confirms non-inferior immunogenicity and safety in RCT.
Objectives: To determine whether a Sabin strain inactivated poliovirus booster (sIPV) given concomitantly (same day, different sites) with MMRV or inactivated hepatitis A vaccine (HepA) is non-inferior in immunogenicity and comparable in safety to separate administration at the 18-month visit. Methods: Open-label, randomized Phase IV trial in healthy children (18~22 months), allocated 2:2:2:1:1 to sIPV&MMRV, sIPV&HepA, sIPV-only, MMRV-only, or HepA-only. Primary endpoints were Day-30 seroconversion rates (SCRs) for poliovirus types 1–3 (sIPV arms) and for HepA (HepA arms). Results: Of 892 screened, 889 were randomized; baseline characteristics were balanced. By Day 30, seroprotection was 100% for PV types 1–3 in all sIPV-containing arms. SCRs were high and similar across concomitant vs. separate administration; all pairwise SCR differences met non-inferiority (−10% margin). Adjusted post-vaccination GMTs were comparable across serotypes. For HepA, Day-30 SPoR was 99.3% vs. 100.0%, and adjusted GMC was 412.2 vs. 465.9 (p = 0.2224). For MMRV, Day-30 SPoR was 100% in both groups with similar adjusted GMCs. Within 30 days, overall adverse reactions were 14.5%/17.4%/16.3%/7.3%/10.8% (sIPV&MMRV/sIPV&HepA/sIPV-only/MMRV-only/HepA-only), mostly mild to moderate; no vaccine-related SAEs (NCT06442449). Conclusions: Same-day sIPV co-administration with MMRV or HepA was non-inferior and well tolerated, supporting programmatic adoption.
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Hu et al. (2025) conducted an RCT in Healthy children (n=889). Sabin strain inactivated poliovirus booster (sIPV) concomitantly with MMRV or HepA vs. Separate administration of sIPV, MMRV, or HepA was evaluated on Day-30 seroconversion rates (SCRs) for poliovirus types 1-3 and for HepA. Same-day co-administration of Sabin strain inactivated poliovirus booster with MMRV or HepA was non-inferior to separate administration for Day-30 seroconversion rates (-10% margin).
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