3 Adjuvated Reduced Dose IPV-Al SSI and Non-adjuvated Full Dose IPV SSI Given as Primary Vaccinations to Infants

Summary

The background of the present clinical trial is the overall aim of the World Health Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to be available in low resource third world countries. The intention of the present phase II clinical trial is to determine if reduced dose(s) of IPV-Al SSI are safe in the target population and do not decrease the immunogenicity clinically significantly compared to full dose IPV Vaccine SSI. The infants will receive three doses of one of the trial vaccines according to the WHO Expanded Program on Immunization (EPI) schedule of 6, 10 and 14 weeks of age. A total of 824 healthy infants will be included in the trial.

Timeline

Start

2015-02

Primary completion

2015-09

Completion

2015-09-26

Outcome

Met primary endpoint

paper All three IPV-Al were non-inferior to IPV, with absolute differences in percentage seroconversion for each poliovirus type being greater than -10% PMID 28454674 ↗

Publications

• Rivera L, Pedersen RS, Pena L, Olsen KJ, Andreasen LV, Kromann I, Nielsen PI, Sorensen C, Dietrich J, Bandyopadhyay AS, Thierry-Carstensen B. Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial. Lancet Infect Dis. 2017 Jul;17(7):745-753. doi: 10.1016/S1473-3099(17)30177-9. Epub 2017 Apr 25.

Drugs

Indications