Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine in 2, 4, 6 Months of Age

Phase 3 Completed 800 enrolled Statens Serum Institut AJ Vaccines A/S · collab Bill and Melinda Gates Foundation · collab Larix A/S · collab Vaxtrials S.A. · collab

RandomizedParallel-groupQuadruple-blindOther

Summary

The trial is a phase III, non-inferiority, observer-blind, randomised, active controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (comparator vaccine). The vaccines will be administered at 2, 4 and 6 months of age.

Timeline

Start: 2017-01-19
Primary completion: 2017-11-14
Completion: 2017-11-14

Outcome

Met primary endpoint

paper Non-inferiority of IPV-Al to standard IPV with respect to seroconversion after vaccination at 2, 4 and 6 months was confirmed for all three poliovirus serotypes. PMID 32273184 ↗

Publications

Saez-Llorens X, Thierry-Carstensen B, Stoey LS, Sorensen C, Wachmann H, Bandyopadhyay AS, Nielsen PI, Kusk MV. Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, following vaccination in children at 2, 4, 6 and at 15-18 months. Vaccine. 2020 May 6;38(21):3780-3789. doi: 10.1016/j.vaccine.2020.02.066. Epub 2020 Apr 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	IPV SSI	Vaccine	—	Intramuscular
Subject	IPV-Al SSI	Vaccine	—	Intramuscular