Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine in 2, 4, 6 Months of Age
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is a phase III, non-inferiority, observer-blind, randomised, active controlled,
      multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and
      IPV SSI (comparator vaccine). The vaccines will be administered at 2, 4 and 6 months of age.
    

Detailed description: 
      In addition to the trial vaccines (IPV-Al SSI or IPV SSI), the trial subjects will receive
      concomitant childhood vaccinations during the trial period. The trial vaccine (IPV-Al SSI or
      IPV SSI) is administered in the RIGHT thigh, whereas the other injectable childhood vaccines
      are administered in the opposite (LEFT) thigh.

      At Visit 1 (inclusion, screening, blood sample, randomisation and 1st vaccination), written
      informed consent is obtained and the subject's eligibility is assessed according to the
      pre-specified in-/exclusion criteria. Information on medical history, demographics and
      concomitant medication are collected and a physical examination is performed and vital signs
      are measured. A prevaccination blood sample is taken for polio antibody determinations and
      the subject is randomly allocated into one of the two vaccination groups and vaccinated. A
      subset of 200 subjects are randomly chosen to have an extra blood sample taken at Visit 3.
      The subject is observed for immediate AEs 30 minutes after all vaccinations. An eDiary,
      thermometer and ruler are handed out to the parents for measurements of temperature and
      recording of injection site reactions and solicited systemic AEs. These activities are
      performed daily, starting on the day of the vaccination and the following 2 days and until
      resolved, and for recording of any other AEs as instructed by the trial staff. A contact to
      the parents via telephone will be made after the vaccination visit to remind the parents to
      fill in the eDiary and to check if they have any questions regarding how use the eDiary.

      At Visit 2 (2nd vaccination), 2 months after Visit 1, the eDiary is collected and AEs and
      concomitant medications are recorded. Contraindications are reviewed, the 2nd vaccination is
      administered, immediate reactions are observed and the eDiary is returned to the partents for
      recordings of AEs and concomitant medications. A contact to the parents via telephone will be
      made after the vaccination visit to remind the parents to fill in the eDiary and to check if
      they have any questions regarding how use the eDiary.

      At Visit 3 (3rd vaccination), 2 months after Visit 2, the eDiary is collected and AEs and
      concomitant medication are recorded. A blood sample from a subset of the subjects is taken
      for polio antibody determinations. Contraindications are reviewed, the 3rd vaccination is
      given, immediate reactions are observed and the eDiary is returned to the parents. A contact
      to the parents via telephone will be made after the vaccination visit to remind the parents
      to fill in the eDiary and to check if they have any questions regarding how use the eDiary.

      At Visit 4 (blood sample and trial completion), 1 month after Visit 3, the eDiary is
      collected and AEs and concomitant medications are recorded and a blood sample for polio
      antibody determination is taken.

      A safety follow-up telephone call will be conducted at 12 months of age.
    

Intervention name(s): IPV-Al SSI; IPV SSI
Intervention type(s): Biological; Biological
Intervention description(s): Total of three primary injections of IPV-Al SSI, one at 2, 4 and 6 months of age; Total of three primary injections of IPV SSI, one at 2, 4 and 6 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