Profylactic immunisation against poliomyelitis MedDRA version: 17.0 Level: LLT Classification code 10054187 Term: Polio immunization System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Poliovaccine SSI
Product Name: Poliovaccine SSI
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Poliovirus types 1, 2 and 3, inactivated
Current Sponsor code: Poliovaccine
Sponsors
Statens Serum Institut
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adolescents from = 10 to = 15 years of age at inclusion 2. Healthy assessed from medical history and oral temperature at inclusion 3.Vaccinated in Denmark according to the current vaccination program of 3 IPV doses in infancy and one IPV dose at pre-school age (i.e. born = 1 July 1999) 4. Signed informed consent from adolescent's parent(s)/legal guardian(s) and from 15 years of age also from the adolescent 5. Grant of authorised person's access to adolescent's medical records from adolescent's parent(s)/legal guardian(s) 6. Is willing and likely to comply with trial procedures Are the trial subjects under 18? yes Number of subjects for this age range: 240 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Vaccinated with IPV = 5 years prior to inclusion 2. Vaccinated with OPV any time prior to inclusion 3. Travelled in wild polio virus endemic region (e.g. Pakistan, Nigeria or Afghanistan) = 5 years prior to inclusion 4. History of serious adverse reaction(s) after any previous vaccination 5. Known or suspected allergy to active or inactive vaccine constituents 6. Vaccinated with a live vaccine (e.g. measles, mumps, rubella, varicella, yellow fever or typhoid) = 1 month prior to inclusion or during the trial. Subjects vaccinated with inactivated vaccines (e.g. tetanus, diphtheria, human papillomavirus, hepatitis A or B) are eligible for inclusion 7. Known or suspected immunodeficiency (e.g. HIV, leukaemia, lymphoma) 8. Severe uncontrolled disease (e.g. diabetes, asthma, epilepsy, heart or Crohn's disease). Patients in controlled medical treatment may be included, as assessed by the investigator 9. In treatment with systemic corticosteroids given p.o., i.v., i.m. = 1 month prior to inclusion or during the trial. Subjects administered corticosteroid topically or by asthma inhalators are eligible for inclusion 10. In treatment with immune modulating products = 3 months prior to inclusion or during the trial, e.g. blood products, immunoglobulins, cytostatics (e.g. methotrexate), TNF-antagonists (e.g. etanercerpt, infliximab, adalimumab, golimumab, certolizumab), or immunosuppressants (e.g. azathioprine or ciclosporin) 11. In treatment with any investigational medicinal product = 3 months prior to inclusion or during the trial 12. A positive pregnancy test result at inclusion (for females who have had their first period) and/or objection to use contraception (for females who are sexually active) 13. Is unsuitable for participation in the trial or is not likely to comply with instructions as assessed by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For each of the 3 poliovirus types 1, 2 and 3 to demonstrate the non-inferiority of the booster effect (day 28 / day 0 titres) of each of the 3 adjuvated reduced dose IPV-Al formulations (1/3 dose, 1/5 dose and 1/10 dose) compared to the non-adjuvated IPV (full dose);Primary end point(s): Booster effect (day 28 / day 0 titres), from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured in pre-vaccination and post-vaccination serum samples by a Vero Cell neutralising assay.;Timepoint(s) of evaluation of this end point: 1 month after the vaccination;Secondary Objective: For each of the 3 poliovirus types 1, 2 and 3 to compare seroconversion (= 4-fold day 28 / day 0 titre rise) rates between the 3 reduced dose IPV-Al formulations and IPV. For each of the 3 poliovirus types 1, 2 and 3 for all investigated IPV formulations to evaluate pre- and post-vaccination geometric mean titres (GMTs) and reverse cumulative distribution curves. For each of the 3 reduced dose IPV-Al formulations and for IPV to evaluate the safety profiles. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Seroconversion (= 4-fold day 28 / day 0 titre rise) rates, from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured in pre-vaccination and post-vaccination serum samples by a Vero Cell neutralising assay. Frequencies of treatment emergent adverse events following the vaccination, recorded in the eCRF. ;Timepoint(s) of evaluation of this end point: 1 month after the vaccination | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Unit
Statens Serum Institut
Outcome results
None listed