Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Immunogenicity and Safety of 3 Adjuvated Reduced Dose Inactivated Polio Vaccines (IPV-Al SSI) and Non-adjuvated Full Dose IPV SSI, Given as Primary Vaccinations to Infants
Brief 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.