3 Adjuvated Reduced Dose IPV-Al SSI and Non-adjuvated Full Dose IPV SSI Given as Primary Vaccinations to Infants
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The trial is a phase II, dose investigation, parallel and multi-group, observer-blind,
      randomised, controlled, multicentre and non-inferiority trial.

      Three investigational reduced dose adjuvated IPV-Al SSI vaccines and full dose IPV SSI
      vaccine will be investigated in four parallel groups:

        -  1/3 IPV-Al SSI

        -  1/5 IPV-Al SSI

        -  1/10 IPV-Al SSI

        -  IPV Vaccine SSI (comparator)

      At Visit 1 (screening and 1st 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 axillary 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 four groups to be vaccinated.

      The subject is observed for ½ an hour after the injection of the investigational medical
      product (IMP) and any immediate adverse events observed are to be recorded. A diary,
      thermometer and ruler are handed out to the parents/guardians so that they can measure daily
      the injection site reactions and the axillary temperature the first 3 days and record any
      adverse event until the next visit.

      At Visit 2 (2nd vaccination visit), 28-42 days after Visit 1, contraindications are reviewed,
      the 2nd vaccination is given, the diary is collected and adverse events and concomitant
      medications are recorded in the eCRF. A new diary is handed out.

      At Visit 3 (3rd vaccination and blood sample visit), 28-42 days after Visit 2, a blood sample
      for immunogenicity assessment is taken, contraindications are reviewed, the 3rd vaccination
      is given, the diary is collected and adverse events and concomitant medications are recorded
      in the eCRF. A new diary is handed out.

      At Visit 4 (blood sample visit), 28-42 days after Visit 3, a blood sample for immunogenicity
      assessment is taken, the diary is collected, and adverse events and concomitant medications
      are recorded in the eCRF. The trial termination form is completed.
    

Intervention name(s): Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI; IPV Vaccine SSI
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Poliomyelitis immunization; primary series