A phase-I, open label clinical trial to assess the safety of Tdap vaccine manufactured by Serum Institute of India Pvt. Ltd. in adults

Vaccine. 2021 Feb 5;39(6):882-885. doi: 10.1016/j.vaccine.2020.12.062. Epub 2021 Jan 8.

Abstract

Background: This first in human study was designed as an open label clinical trial to assess the safety and tolerability of Serum Institute of India Pvt. Ltd. (SIIPL) Tdap vaccine in healthy adult volunteers, aged 18-45 years.

Methods: A total of 24 healthy adults were administered a 0.5 ml single dose of SIIPL Tdap vaccine intramuscularly, and were followed for one month for safety outcomes viz., immediate, solicited, unsolicited and serious adverse events.

Results: 23 subjects completed the study in compliance with the study protocol. None of the participants experienced any immediate adverse events or any local or systemic solicited adverse events.

Conclusion: Tdap vaccine manufactured by Serum Institute of India Pvt. Ltd. is safe and well tolerable in adults. It was concluded that further clinical development of this vaccine should continue to assess its safety and immunogenicity, in the target population. Clinical Trial Registration - CTRI/2017/03/008003.

Keywords: Adult; Phase I; Safety; Tdap; Vaccine.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Bacterial Vaccines*
  • Humans
  • Immunogenicity, Vaccine*
  • India
  • Middle Aged
  • Young Adult

Substances

  • Bacterial Vaccines