In:
The Journal of Infectious Diseases, Oxford University Press (OUP), Vol. 220, No. 10 ( 2019-10-08), p. 1551-1557
Abstract:
The Sabin strain–based inactivated polio vaccine (sIPV) plays a vital role in eradicating poliomyelitis in developing countries. Methods The study was designed as a randomized, controlled, double-blinded, noninferiority trial. A total of 1200 healthy infants aged 60–90 days were enrolled and randomly assigned to receive 3 doses of either sIPV (the experimental arm) or IPV (the control arm) at days 0, 30, and 60. Immunogenicity and safety outcomes were assessed using the per-protocol and safety populations, respectively. Results A total of 553 and 562 participants in the sIPV and IPV groups, respectively, were included in the per-protocol population. Seroconversion rates in the sIPV and IPV groups were 98.0% and 94.1%, respectively, for type 1 poliovirus (P 〈 .01); 94.8% and 84.0%, respectively, for type 2 (P 〈 .01); and 98.9% and 97.7%, respectively, for type 3 (P = .11). A total of 599 and 600 participants in the sIPV and IPV groups, respectively, were included in the safety population. Fever was the most common adverse event, occurring in 61.6% and 49.8% of participants in the experimental and control arms, respectively (P 〈 .01). Conclusions The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile. Clinical Trials Registration NCT03526978.
Type of Medium:
Online Resource
ISSN:
0022-1899
,
1537-6613
DOI:
10.1093/infdis/jiy736
Language:
English
Publisher:
Oxford University Press (OUP)
Publication Date:
2019
detail.hit.zdb_id:
1473843-0
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