Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given at 6, 10, 14 Weeks and 9 Months

Summary

The trial is a phase III, non-inferiority, observer-blind, randomised, controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (reference vaccine)

Timeline

Start

2017-02-06

Primary completion

2017-09-21

Completion

2018-03-12

Outcome

Met primary endpoint

paper IPV-Al was non-inferior to IPV, as the lower 95% confidence limits of the treatment differences were above the predefined -10%-point limit PMID 31703934 ↗

Publications

• Bravo LC, Carlos JC, Gatchalian SR, Montellano MEB, Tabora CFCB, Thierry-Carstensen B, Tingskov PN, Sorensen C, Wachmann H, Bandyopadhyay AS, Nielsen PI, Kusk MV. Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, compared to standard IPV: A phase 3 observer-blinded, randomised, controlled trial in infants vaccinated at 6, 10, 14 weeks and 9 months of age. Vaccine. 2020 Jan 16;38(3):530-538. doi: 10.1016/j.vaccine.2019.10.064. Epub 2019 Nov 5.

Drugs

Indications