Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given at 6, 10, 14 Weeks and 9 Months
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is a phase III, non-inferiority, observer-blind, randomised, controlled,
      multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and
      IPV SSI (reference vaccine)
    

Detailed description: 
      In addition to the trial vaccine (IPV-Al SSI or IPV SSI), the trial subjects will receive
      vaccinations with the Philippine national childhood vaccination programme. The trial vaccine
      (IPV-Al SSI or IPV SSI) is administered in the RIGHT thigh, where other injectable childhood
      vaccines are administered in the opposite (LEFT) thigh. There are 6 trial visits:

      Visit 1 (screening, 1st vaccination and blood sampling visit): written informed consent is
      obtained. Information on medical history, demographics and concomitant medication is
      collected, a physical examination is performed and the subject's eligibility is assessed
      according to the pre-specified in-/exclusion criteria. A pre-vaccination blood sample is
      taken for polio antibody measurements, and the subject is randomly allocated into one of the
      2 groups and vaccinated. If it is not possible to draw a blood sample on Visit 1 the child
      cannot continue in the trial. The subject is observed for immediate AEs ½ an hour after all
      vaccinations. A diary, a ruler and a thermometer are handed out to the parents to record
      daily the temperature and injection site reactions, during the first 3 days after the
      vaccinations until resolved and to record any AEs as instructed by the trial staff. 2 days
      after Visit 1 the trial staff will make a telephone call to the parent(s)/guardian(s) to
      clarify any questions regarding the AE recording in the diary.

      Visit 2 (2nd vaccination visit), 28-42 days after Visit 1: contraindications are reviewed,
      the 2nd vaccination is given, the diary is collected and AEs and concomitant medications
      (CMs) are recorded. A new diary is handed out.

      2 days after Visit 2 the trial staff will make a telephone call to the parent(s)/guardian(s)
      to clarify any questions regarding the AE recording in the diary.

      Visit 3 (3rd vaccination visit), 28-42 days after Visit 2: contraindications are reviewed,
      the 3rd vaccination is given, the diary is collected and AEs and CMs are recorded. A new
      diary is handed out. 2 days after Visit 3 the trial staff will make a telephone call to the
      parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.

      Visit 4 (blood sample visit), 28-42 days after Visit 3: a blood sample for polio antibody
      measurements is taken, the diary is collected, and AEs and CMs are recorded.

      Visit 5 (4th vaccination and blood sample visit), at 9 months of age (+14 days): a blood
      sample is taken for polio antibody measurements, contraindications are reviewed, the 4th
      vaccination is given, and AEs and CMs are recorded. A new diary is handed out. 2 days after
      Visit 5 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify
      any questions regarding the AE recording in the diary.

      Visit 6 (blood sample and end of trial visit), 28-42 days after Visit 5: a blood sample for
      polio antibody measurements is taken, the diary is collected, and AEs and CMs are recorded.
      The end of trial form is completed.
    

Intervention name(s): IPV-Al SSI; IPV SSI
Intervention type(s): Biological; Biological
Intervention description(s): 3 primary injections of IPV-Al SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age; 3 primary injections of IPV SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age
Other intervention name(s): IPV Vaccine SSI
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other