Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Feb 8;10(2):254.
doi: 10.3390/vaccines10020254.

Safety, Immunogenicity and Lot-to-Lot Consistency of Sabin-Strain Inactivated Poliovirus Vaccine in 2-Month-Old Infants: A Double-Blind, Randomized Phase III Trial

Yan Zheng  1 , Zhifang Ying  2 , Yanxiang Zou  1 , Taotao Zhu  3 , Dinggu Qian  4 , Weixiao Han  3 , Ya Jiang  5 , Zhiwei Jiang  6 , Xingyan Li  7 , Jianfeng Wang  3 , Jin Lei  8 , Li Xu  9 , Deyu Jiang  10 , Changgui Li  2 , Xiaoqiang Liu  1
Affiliations

Safety, Immunogenicity and Lot-to-Lot Consistency of Sabin-Strain Inactivated Poliovirus Vaccine in 2-Month-Old Infants: A Double-Blind, Randomized Phase III Trial

Yan Zheng et al. Vaccines (Basel). .

Abstract

Background: The Sabin-strain-based inactivated poliovirus vaccine (sIPV) plays an important role in poliomyelitis eradication in developing countries. As part of the phase III clinical development program, this study aimed to evaluate the safety, immunogenicity and lot-to-lot consistency of the sIPV in 2-month-old infants.

Method: We conducted a phase III, randomized, double-blind, positive-controlled trial in which 1300 healthy infants were randomly assigned to four groups in a 1:1:1:1 ratio to receive one of the three lots of the sIPV or the control IPV at 2, 3 and 4 months of age. Serum samples were collected before the first dose and 30 days after the third dose of vaccination to assess the immunogenicity. Solicited local and systemic reactions were recorded within 7 days and unsolicited adverse events within 30 days after each vaccination.

Results: Of the 1300 randomized infants, 1190 infants completed the study and were included in the per-protocol population. The seroconversion rates in the three lots of the sIPV were 95.67%, 97.03% and 95.59%, respectively, for type 1; 94.33%, 93.73% and 92.88%, respectively, for type 2; and 98.67%, 99.67% and 99.32%, respectively, for type 3. The ratios of GMTs for poliovirus types 1, 2 and 3 of each pair of lots were all between 0.67 and 1.50, therefore meeting the predefined immunological equivalence criteria. For the seroconversion rate of poliovirus types 1, 2 and 3, the pooled sIPV group was non-inferior to the IPV group. The incidence of solicited and unsolicited adverse reactions (ARs) was similar in the pooled sIPV lots and the IPV group, and most of them were mild to moderate in severity. Non-vaccine-related serious adverse events (SAEs) were reported.

Conclusions: Three consecutive lots of sIPV demonstrated robust and consistent immunogenicity. The safety and tolerability of the sIPV was acceptable and similar to that of the IPV.

Keywords: Sabin strain; immunogenicity; inactivated poliovirus vaccine; lot-to-lot consistency; safety.

PubMed Disclaimer

Conflict of interest statement

T.Z., W.H., J.W. and L.X. are employees of Sinovac Biotech Co., Ltd. All the other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Trial profile. Flow chart of participants through screening, random assignment and analysis. Abbreviations: sIPV: Sabin-strain inactivated poliovirus vaccine (test group); IPV: inactivated poliovirus vaccine (control group); SS: safety set; FAS: full analysis set; PPS: per-protocol set.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Dixon B. Medicine and the media: Polio still paralyses (Albert Sabin, Jonas Salk) Br. J. Hosp. Med. 1977;18:595. - PubMed
    1. World Health Organization Does Polio Still Exist? Is It Curable? [(accessed on 17 November 2021)]. Available online: http://www.who.int/features/qa/07/en/
    1. Centers for Disease Control and Prevention What We Do. [(accessed on 3 January 2022)]; Available online: https://www.cdc.gov/polio/what-we-do/
    1. Centers for Disease Control and Prevention Certification of poliomyelitis eradication—Western Pacific Region, October 2000. MMWR Morb. Mortal. Wkly Rep. 2001;50:1–3. - PubMed
    1. International Graduate Programs for Educators Polio This Week. [(accessed on 17 November 2021)]. Available online: https://polioeradication.org/polio-today/polio-now/this-week/