Status:
COMPLETED
3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, as Booster Vaccination to Adolescents
Lead Sponsor:
Statens Serum Institut
Collaborating Sponsors:
Bill and Melinda Gates Foundation
CCBR Clinical Research
Conditions:
Immunization, Booster
Eligibility:
All Genders
10-15 years
Phase:
PHASE1
PHASE2
Brief Summary
The background of the 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...
Detailed Description
The trial is a phase I/II, parallel- and multi-group, randomised, controlled, multi-centre, non-inferiority trial investigating the safety and immunogenicity of 4 IPV vaccines, given as a booster vacc...
Eligibility Criteria
Inclusion
- Adolescents from ≥ 10 to ≤ 15 years of age at inclusion
- Healthy assessed from medical history and oral temperature at inclusion
- 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)
- Signed informed consent from adolescent's parent(s)/legal guardian(s)
- Grant of authorised person's access to adolescent's medical records from adolescent's parent(s)/legal guardian(s)
- Is willing and likely to comply with trial procedures
Exclusion
- Vaccinated with IPV ≤ 5 years prior to inclusion
- Vaccinated with OPV any time prior to inclusion
- Travelled in wild polio virus endemic region ≤ 5 years prior to inclusion
- History of serious adverse reaction(s) after any previous vaccination
- Known or suspected allergy to active or inactive vaccine constituents
- 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
- Known or suspected immunodeficiency (e.g. HIV, leukaemia, lymphoma)
- 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
- 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
- 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)
- In treatment with any investigational medicinal product ≤ 3 months prior to inclusion or during the trial
- 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)
- Is unsuitable for participation in the trial or is not likely to comply with instructions as assessed by the investigator
Key Trial Info
Start Date :
November 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2015
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT02280447
Start Date
November 13 2014
End Date
March 5 2015
Last Update
November 14 2018
Active Locations (3)
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1
CCBR
Aalborg, Denmark, DK-9000
2
CCBR
Ballerup Municipality, Denmark, DK-2750
3
CCBR
Vejle, Denmark, DK-7100