n/a
Abstract Title:

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

Abstract Source:

J Infect Dis. 2019 Oct 8 ;220(10):1551-1557. PMID: 30958543

Abstract Author(s):

Yuemei Hu, Jianfeng Wang, Gang Zeng, Kai Chu, Deyu Jiang, Fengdong Zhu, Zhifang Ying, Lei Chen, Changgui Li, Fengcai Zhu, Weidong Yin

Article Affiliation:

Yuemei Hu

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.

Study Type : Human Study
Additional Links
Anti Therapeutic Actions : Vaccination: Polio : CK(309) : AC(65)

Print Options


Key Research Topics

Sayer Ji
Founder of GreenMedInfo.com

Subscribe to our informative Newsletter & get Nature's Evidence-Based Pharmacy

Our newsletter serves 500,000 with essential news, research & healthy tips, daily.

Download Now

500+ pages of Natural Medicine Alternatives and Information.

This website is for information purposes only. By providing the information contained herein we are not diagnosing, treating, curing, mitigating, or preventing any type of disease or medical condition. Before beginning any type of natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional.

© Copyright 2008-2021 GreenMedInfo.com, Journal Articles copyright of original owners, MeSH copyright NLM.