3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, as Booster Vaccination to Adolescents

November 12, 2018 updated by: Statens Serum Institut

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 vaccination to adolescents who have completed primary infant vaccination and pre-school booster vaccination with IPV in Denmark.

At Visit 1 (Screening and 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 oral 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 4 groups to be vaccinated.

The subjects are observed for ½ an hour after the IMP injection and any immediate adverse events observed are to be recorded. A diary, thermometer and ruler are handed out to the subjects so that they can measure daily the injection site reactions and temperature the first 3 days (72 hours) and record any adverse event until the follow-up visit.

At Visit 2 (Follow-up visit), 28-35 days later, a post-vaccination blood sample is taken, the diary is collected, and adverse events and concomitant medications are recorded in the eCRF.

The trial is conducted in two parts. In the first part, 50 % of the subjects are randomised with allocation weights 4:4:1:1 to IPV SSI, 1/3 IPV-Al SSI, 1/5 IPV-Al SSI or 1/10 IPV-Al SSI, respectively. In the second part, the corresponding allocation weights are 1:1:4:4 for the remaining 50 % of the subjects.

After inclusion of 50 % of the subjects, an interim immunogenicity analysis is planned. While the interim analysis on 50% of the completed subjects is performed, the trial continues to recruit and randomise the remaining 50% of the subjects.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, DK-9000
        • CCBR
      • Ballerup, Denmark, DK-2750
        • CCBR
      • Vejle, Denmark, DK-7100
        • CCBR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1/3 IPV-Al SSI

Reduced dose Al(OH)3 adjuvated IPV SSI with 1/3 of dose in full dose non-adjuvated IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU)

1 X 0.5 mL suspension for injection for intramuscular use
Biological: 1/3 IPV-Al SSI, manufactured by SSI, Denmark
Intramuscular injection of 0.5 mL vaccine into deltoid muscle
Other Names:
  • Reduced dose (1/3) IPV adjuvated to Al(OH)3
Experimental: 1/5 IPV-Al SSI

Reduced dose Al(OH)3 adjuvated IPV SSI with 1/5 of dose in full dose non-adjuvated IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU)

1 X 0.5 mL suspension for injection for intramuscular use
Biological: 1/5 IPV-Al SSI, manufactured by SSI, Denmark
Intramuscular injection of 0.5 mL vaccine into deltoid muscle
Other Names:
  • Reduced dose (1/5) IPV adjuvated to Al(OH)3
Experimental: 1/10 IPV-Al SSI

Reduced dose Al(OH)3 adjuvated IPV SSI with 1/10 of dose in full dose non-adjuvated IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU)

1 X 0.5 mL suspension for injection for intramuscular use
Biological: 1/10 IPV-Al SSI, manufactured by SSI, Denmark
Intramuscular injection of 0.5 mL vaccine into deltoid muscle
Other Names:
  • Reduced dose (1/10) IPV adjuvated to Al(OH)3
Active Comparator: IPV SSI

Non-adjuvated full dose IPV SSI (i.e.: Type 1:40 DU; Type 2:8 DU; Type 3:32 DU)

1 X 0.5 mL solution for injection for intramuscular use
Biological: IPV SSI, manufactured by SSI, Denmark
Intramuscular injection of 0.5 mL vaccine into deltoid muscle
Other Names:
  • Full dose inactivated polio vaccine, non-adjuvated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: On the day of and 28 days after the vaccination
On the day of and 28 days after the vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: On the day of and 28 days after the vaccination
On the day of and 28 days after the vaccination
Frequencies of adverse events following the vaccination
Time Frame: On the day of and 28 days after the vaccination
On the day of and 28 days after the vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Statens Serum Institut

Collaborators

Bill and Melinda Gates Foundation
Larix A/S
CCBR Clinical Research

Investigators

  • Principal Investigator: Line Markdanner Lindgren, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 5, 2015

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIPV-04
  • 2014-000052-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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