Safety and efficay of 3 new low dose polio vaccines with adjuvant compared to a full dose polio vaccine without adjuvant

• Conditions: Profylactic immunisation against poliomyelitis; MedDRA version: 17.0Level: LLTClassification code 10054187Term: Polio immunizationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2014-000052-29-DK
• Lead Sponsor: Statens Serum Institut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-16
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified