Clinical Trial: Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine in 2, 4, 6 Months of Age

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI, in Comparison to Non-adjuvanted Full Dose IPV SSI, in Infants Vaccinated at 2,

Brief 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 Summary:

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 parten
Sponsor: Statens Serum Institut

Current Primary Outcome: Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI in infants [ Time Frame: Change from baseline to one month after 3rd vaccination ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse events following vaccinations (key secondary) [ Time Frame: After primary injections at 2, 4 and 6 months of age ]
  • Subjects with seroprotection against poliovirus types 1, 2 and 3 [ Time Frame: One months after 3rd vaccination ]
  • Subjects with poliovirus types 1, 2 and 3 post-vaccination titres >= 4-fold above estimated titre of maternal antibody [ Time Frame: One months after 3rd vaccination ]
  • Geometric mean titres (GMTs) and median titers for poliovirus types 1, 2 and 3 [ Time Frame: One months after 3rd vaccination ]
  • Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3 [ Time Frame: From baseline and one months after 3rd vaccination ]


Original Secondary Outcome: Same as current

Information By: Statens Serum Institut

Dates:
Date Received: January 16, 2017
Date Started: January 19, 2017
Date Completion: March 2018
Last Updated: January 23, 2017
Last Verified: January 2017