NCT02280447

3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, as Booster Vaccination to Adolescents

Safety and Immunogenicity of 3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, Given as a Booster Vaccination to Adolescents With a History of IPV Vaccination at 3, 5, 12 Months and 5 Years of Age

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: All
• Age: 10 Years – 15 Years
• Healthy volunteers: Accepted

Summary

The background of the 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 become available in low resource third World countries. The primary objective of the phase I/II clinical trial is to provide proof of concept (POC) that up to 10 times dose reduction of IPV SSI does not decrease the immunogenicity clinically significantly compared to full dose IPV SSI, by demonstrating the non-inferiority of the booster effects of each of 3 Al(OH)3 adjuvated reduced dose IPV formulations (1/3 IPV-Al SSI, 1/5 IPV-Al SSI and 1/10 IPV-Al SSI) compared to non-adjuvated full dose IPV SSI. A total of 240 healthy adolescents with a history of IPV SSI vaccination at 3, 5, 12 months and 5 years of age according to the Danish vaccination program will be included in the trial.

Detailed description

The trial is a phase I/II, parallel- and multi-group, randomised, controlled, multi-centre, non-inferiority trial investigating the safety and immunogenicity of 4 IPV vaccines, given as a booster vaccination to adolescents who have completed primary infant vaccination and pre-school booster vaccination with IPV in Denmark. At Visit 1 (Screening and vaccination visit), written informed consent is obtained and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria, including measurement of oral temperature. If the subject is included, a pre-vaccination blood sample is taken for polio antibody determinations, and the subject is randomly allocated into one of the 4 groups to be vaccinated. The subjects are observed for ½ an hour after the IMP injection and any immediate adverse events observed are to be recorded. A diary, thermometer and ruler are handed out to the subjects so that they can measure daily the injection site reactions and temperature the first 3 days (72 hours) and record any adverse event until the follow-up visit. At Visit 2 (Follow-up visit), 28-35 days later, a post-vaccination blood sample is taken, the diary is collected, and adverse events and concomitant medications are recorded in the eCRF. The trial is conducted in two parts. In the first part, 50 % of the subjects are randomised with allocation weights 4:4:1:1 to IPV SSI, 1/3 IPV-Al SSI, 1/5 IPV-Al SSI or 1/10 IPV-Al SSI, respectively. In the second part, the corresponding allocation weights are 1:1:4:4 for the remaining 50 % of the subjects. After inclusion of 50 % of the subjects, an interim immunogenicity analysis is planned. While the interim analysis on 50% of the completed subjects is performed, the trial continues to recruit and randomise the remaining 50% of the subjects.

Conditions

• Immunization, Booster

Interventions

Type	Name	Description
BIOLOGICAL	1/3 IPV-Al SSI, manufactured by SSI, Denmark	Intramuscular injection of 0.5 mL vaccine into deltoid muscle
BIOLOGICAL	1/5 IPV-Al SSI, manufactured by SSI, Denmark	Intramuscular injection of 0.5 mL vaccine into deltoid muscle
BIOLOGICAL	1/10 IPV-Al SSI, manufactured by SSI, Denmark	Intramuscular injection of 0.5 mL vaccine into deltoid muscle
BIOLOGICAL	IPV SSI, manufactured by SSI, Denmark	Intramuscular injection of 0.5 mL vaccine into deltoid muscle

Timeline

• Start date: 2014-11-13
• Primary completion: 2015-03-01
• Completion: 2015-03-05
• First posted: 2014-10-31
• Last updated: 2018-11-14

Locations

3 sites across 1 country: Denmark