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J Infect Dis. 2019 Apr 8. pii: jiy736. doi: 10.1093/infdis/jiy736. [Epub ahead of print]

Immunogenicity and Safety of a Sabin Strain-Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial.

Author information

1
Department of Vaccine Evaluation, Nanjing.
2
Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Sinovac Biotech, Beijing.
3
Department of Clinical Research, Sinovac Biotech, Beijing.
4
Center of Research and Development, Sinovac Biotech, Beijing.
5
Guanyun County Center for Disease Control and Prevention, Guanyun.
6
Pizhou County Center for Disease Control and Prevention, Pizhou, China.
7
Office of the Deputy Director, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing.
8
Office of the General Manager, Sinovac Biotech, Beijing.

Abstract

BACKGROUND:

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.

KEYWORDS:

Poliovirus; Sabin strain; inactivated vaccine; phase 3 trial

PMID:
30958543
DOI:
10.1093/infdis/jiy736

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