Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given as a Booster at Age 15-18 Months
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III assessing the safety and immunogenicity of adjuvanted the reduced dose
      inactivated polio vaccine, IPV-Al SSI given as a booster vaccination to infants who were
      previously immunised with primary vaccination of IPV-Al SSI or IPV SSI in the VIPV-07 trial
      at age 2, 4, and 6 months. The IPV-Al SSI vaccine will be given at the age of 15-18 months.
    

Detailed description: 
      At Visit 1 (screening, blood sample, and vaccination), the subject's eligibility is assessed
      according to the pre-specified in-/exclusion criteria. Information on medical history, and
      concomitant medication are collected and a physical examination is performed and vital signs
      are measured (demographics data is captured from the VIPV-07 database). The health assessment
      of the subject will include measurement of height, weight, temperature, heart rate,
      respiratory rate (breathing) and a general physical examination (which can include skin,
      head, eyes, ears, nose, throat, heart, lungs, lymph nodes, abdomen, and the musculoskeletal
      system). A pre-vaccination blood sample is taken for polio antibody determinations. The
      subject is vaccinated with IPV-Al (and concomitant vaccine(s) according to national
      guidelines, if relevant) and subsequently observed for immediate adverse events 30 minutes
      after the vaccination. An eDiary, a thermometer and a ruler are handed out to the
      parent(s)/guardian(s) for measurements and recording of temperature, injection site reactions
      and solicited systemic adverse events (AEs). These activities are performed daily, starting
      on the day of the vaccination and the following 2 days and until resolved. Any other AEs are
      recorded in the eDiary as instructed by the trial staff. A contact to the
      parent(s)/guardian(s) via telephone will be made after the vaccination visit to remind and
      check if the parent(s)/guardian(s) have any questions regarding how to fill in the eDiary.

      At Visit 2 (blood sample and trial completion), 1 month after Visit 1, the eDiary is
      collected, adverse events and concomitant medications are recorded, a blood sample for
      poliovirus antibody determination is taken and the end of the trial page is completed.

      In addition to the trial vaccine, the trial subjects will receive concomitant routine
      childhood vaccinations. The trial vaccine is administered in the anterolateral aspect of the
      right thigh, whereas the other injectable childhood vaccines are administered in the left
      thigh.
    

Intervention name(s): IPV-Al SSI
Intervention type(s): Biological
Intervention description(s): IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. A single dose of the IPV-Al SSI will be given to infants age 15-18 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other