NCT03032419

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

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, 10, 14 Weeks and 9 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,002 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: All
• Age: 6 Weeks – 9 Months
• Healthy volunteers: Accepted

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.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	IPV-Al SSI	3 primary injections of IPV-Al SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age
BIOLOGICAL	IPV SSI	3 primary injections of IPV SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age

Timeline

• Start date: 2017-02-06
• Primary completion: 2017-09-21
• Completion: 2018-03-12
• First posted: 2017-01-26
• Last updated: 2018-11-14

Locations

1 site across 1 country: Philippines