3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, as Booster Vaccination to Adolescents
Condition: Immunization, Booster
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): 1/3 IPV-Al SSI, manufactured by SSI, Denmark; 1/5 IPV-Al SSI, manufactured by SSI, Denmark; 1/10 IPV-Al SSI, manufactured by SSI, Denmark; IPV SSI, manufactured by SSI, Denmark
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection of 0.5 mL vaccine into deltoid muscle; Intramuscular injection of 0.5 mL vaccine into deltoid muscle; Intramuscular injection of 0.5 mL vaccine into deltoid muscle; Intramuscular injection of 0.5 mL vaccine into deltoid muscle
Other intervention name(s): Reduced dose (1/3) IPV adjuvated to Al(OH)3; Reduced dose (1/5) IPV adjuvated to Al(OH)3; Reduced dose (1/10) IPV adjuvated to Al(OH)3; Full dose inactivated polio vaccine, non-adjuvated
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention