Clinical Trial: Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given at 6, 10, 14 Weeks and 9 Months

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 6,

Brief 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 Summary:

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.

Sponsor: Statens Serum Institut

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse event 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 seroprotection against poliovirus types 1, 2 and 3 [ Time Frame: Before and one month after the 4th vaccination ]
  • Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above the estimated titre of maternal antibody [ Time Frame: One months after 3rd vaccination ]
  • Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3 [ Time Frame: One months after 3rd vaccination ]
  • Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3 [ Time Frame: Before and one month after the 4th vaccination ]
  • Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3 [ Time Frame: From baseline, one month after 3rd vaccination, and before and one month after 4th vaccination ]


Original Secondary Outcome: Same as current

Information By: Statens Serum Institut

Dates:
Date Received: January 16, 2017
Date Started: February 6, 2017
Date Completion: February 2018
Last Updated: February 13, 2017
Last Verified: February 2017