Immunization, Booster Clinical Trial
Official title:
Safety and Immunogenicity of 3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, Given as a Booster Vaccination to Adolescents With a History of IPV Vaccination at 3, 5, 12 Months and 5 Years of Age
| Verified date | November 2018 |
| Source | Statens Serum Institut |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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) against poliovirus types 1, 2 and 3, at an affordable price, needs to
become available in low resource third World countries.
The primary objective of the phase I/II clinical trial is to provide proof of concept (POC)
that up to 10 times dose reduction of IPV SSI does not decrease the immunogenicity clinically
significantly compared to full dose IPV SSI, by demonstrating the non-inferiority of the
booster effects of each of 3 Al(OH)3 adjuvated reduced dose IPV formulations (1/3 IPV-Al SSI,
1/5 IPV-Al SSI and 1/10 IPV-Al SSI) compared to non-adjuvated full dose IPV SSI.
A total of 240 healthy adolescents with a history of IPV SSI vaccination at 3, 5, 12 months
and 5 years of age according to the Danish vaccination program will be included in the trial.
| Status | Completed |
| Enrollment | 240 |
| Est. completion date | March 5, 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 10 Years to 15 Years |
| Eligibility |
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) 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 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 = 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | CCBR | Aalborg | |
| Denmark | CCBR | Ballerup | |
| Denmark | CCBR | Vejle |
| Lead Sponsor | Collaborator |
|---|---|
| Statens Serum Institut | Bill and Melinda Gates Foundation, CCBR Clinical Research, Larix A/S |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | On the day of and 28 days after the vaccination | ||
| Secondary | 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 | On the day of and 28 days after the vaccination | ||
| Secondary | Frequencies of adverse events following the vaccination | On the day of and 28 days after the vaccination |