Key result
Concomitant administration of sIPV and DTaP vaccines in infants demonstrated non-inferior immunogenicity (P<0.001 for non-inferiority) and acceptable safety compared to separate administration.
Why the study?
Because sIPV and DTaP vaccination schedules overlap at 3 and 4 months of age in China, evaluating concomitant administration aimed to reduce treatment burden and increase coverage.
Does concomitant administration of sIPV and DTaP maintain immunogenicity and safety compared to separate administration in healthy infants?
RCT (n=702)
Open-label
Block randomization (1:1:1)
Yes
Does concomitant administration of sIPV and DTaP maintain immunogenicity and safety compared to separate administration in healthy infants?
p-value: p=<0.001
Co-administration of sIPV and DTaP in infants provides non-inferior immunogenicity compared to separate administration, supporting simultaneous vaccination to improve coverage despite a slight increase in mild local reactions and fever.
Supports co-administration of sIPV and DTaP in infants to improve coverage; extends RCT evidence for combined pediatric schedules.
Key point: Considering that vaccination with the sIPV and DTaP overlap at the ages of 3 and 4 months in China, to reduce the burden of treatment on parents and increase vaccination coverage rates, we designed a postmarket clinical study of co-administration. Background: The Sabin-strain-based inactivated poliovirus vaccine (sIPV) and the diphtheria-tetanus-acellular pertussis vaccine (DTaP) have been licensed in China for many years. To conduct a clinical study on the safety and immunogenicity of the sIPV when administered concomitantly with the DTaP. Methods: The study population was divided into three groups: group 1 was the sIPV+ DTaP concomitant administration group, group 2 was the sIPV inoculation group, and group 3 was the DTaP inoculation group. Blood samples were collected prevaccination and 30 days postvaccination, and serum antibody levels were detected. Results: This study showed that the seropositive and seroconversion rates of type 1, 2 and 3 poliovirus in group 1 were higher than those in group 2, with no statistically significant difference after vaccination (P>0.05). Groups 1 and 3 also showed similar responses for all vaccine antigens except anti-FHA (97.65 (94.09-99.36) vs. 100 (97.89-100)). The geometric mean titers (GMTs) for the DTaP and sIPV among the groups were comparable, and the non-inferiority t test result was P<0.001. The number of local adverse events (AEs) reported in group 1 (29.91%) were larger than those in group 2 (12.39%) and group 3 (21.93%), among which the most common was redness. Similarly, the most common systemic AE was fever. All 5 severe AE (SAE) cases were determined by experts to be unrelated to the vaccines during the study. Conclusions: The evidence of similar seroconversion and safety with co-administered DTaP and sIPV supports the co-administration supports the introduction of a strategy of simultaneous administration of both vaccines into routine infant immunization, and it could increase vaccination coverage and protect more infants from morbidity and mortality from these related diseases. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04054882?term=NCT04054882&cntry=CN&draw=2&rank=1, identifier NCT04054882.
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Sun et al. (2022) conducted an RCT in Healthy infants (vaccination) (n=702). Concomitant administration of sIPV and DTaP vaccines vs. Separate administration of sIPV or DTaP vaccines was evaluated on Seroconversion rates of neutralizing antibodies 30 days postvaccination (p=<0.001). Concomitant administration of sIPV and DTaP vaccines in infants demonstrated non-inferior immunogenicity (P<0.001 for non-inferiority) and acceptable safety compared to separate administration.
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