Poliomyelitis Clinical Trial
Official title:
Immunogenicity and Safety of 3 Adjuvated Reduced Dose Inactivated Polio Vaccines (IPV-Al SSI) and Non-adjuvated Full Dose IPV SSI, Given as Primary Vaccinations to Infants at 6, 10 and 14 Weeks of Age
The background of the present clinical trial is the overall aim of the World Health
Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan,
inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price,
needs to be available in low resource third world countries. The intention of the present
phase II clinical trial is to determine if reduced dose(s) of IPV-Al SSI are safe in the
target population and do not decrease the immunogenicity clinically significantly compared to
full dose IPV Vaccine SSI. The infants will receive three doses of one of the trial vaccines
according to the WHO Expanded Program on Immunization (EPI) schedule of 6, 10 and 14 weeks of
age.
A total of 824 healthy infants will be included in the trial.
The trial is a phase II, dose investigation, parallel and multi-group, observer-blind,
randomised, controlled, multicentre and non-inferiority trial.
Three investigational reduced dose adjuvated IPV-Al SSI vaccines and full dose IPV SSI
vaccine will be investigated in four parallel groups:
- 1/3 IPV-Al SSI
- 1/5 IPV-Al SSI
- 1/10 IPV-Al SSI
- IPV Vaccine SSI (comparator)
At Visit 1 (screening and 1st vaccination visit), written informed consent is obtained and
the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria,
including measurement of axillary temperature. If the subject is included, a pre-vaccination
blood sample is taken for polio antibody determinations, and the subject is randomly
allocated into one of the four groups to be vaccinated.
The subject is observed for ½ an hour after the injection of the investigational medical
product (IMP) and any immediate adverse events observed are to be recorded. A diary,
thermometer and ruler are handed out to the parents/guardians so that they can measure daily
the injection site reactions and the axillary temperature the first 3 days and record any
adverse event until the next visit.
At Visit 2 (2nd vaccination visit), 28-42 days after Visit 1, contraindications are reviewed,
the 2nd vaccination is given, the diary is collected and adverse events and concomitant
medications are recorded in the eCRF. A new diary is handed out.
At Visit 3 (3rd vaccination and blood sample visit), 28-42 days after Visit 2, a blood sample
for immunogenicity assessment is taken, contraindications are reviewed, the 3rd vaccination
is given, the diary is collected and adverse events and concomitant medications are recorded
in the eCRF. A new diary is handed out.
At Visit 4 (blood sample visit), 28-42 days after Visit 3, a blood sample for immunogenicity
assessment is taken, the diary is collected, and adverse events and concomitant medications
are recorded in the eCRF. The trial termination form is completed.
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