NCT02280447

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) 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

November 13, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2015

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

October 29, 2014

Last Update Submit

November 12, 2018

Conditions

Immunization, Booster

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • Frequencies of adverse events following the vaccination

    On the day of and 28 days after the vaccination

Study Arms (4)

1/3 IPV-Al SSI

EXPERIMENTAL

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

1/5 IPV-Al SSI

EXPERIMENTAL

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

1/10 IPV-Al SSI

EXPERIMENTAL

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

IPV SSI

ACTIVE COMPARATOR

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

Interventions

1/3 IPV-Al SSI, manufactured by SSI, DenmarkBIOLOGICAL

Intramuscular injection of 0.5 mL vaccine into deltoid muscle

Also known as: Reduced dose (1/3) IPV adjuvated to Al(OH)3
1/3 IPV-Al SSI
1/5 IPV-Al SSI, manufactured by SSI, DenmarkBIOLOGICAL

Intramuscular injection of 0.5 mL vaccine into deltoid muscle

Also known as: Reduced dose (1/5) IPV adjuvated to Al(OH)3
1/5 IPV-Al SSI
1/10 IPV-Al SSI, manufactured by SSI, DenmarkBIOLOGICAL

Intramuscular injection of 0.5 mL vaccine into deltoid muscle

Also known as: Reduced dose (1/10) IPV adjuvated to Al(OH)3
1/10 IPV-Al SSI
IPV SSI, manufactured by SSI, DenmarkBIOLOGICAL

Intramuscular injection of 0.5 mL vaccine into deltoid muscle

Also known as: Full dose inactivated polio vaccine, non-adjuvated
IPV SSI

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • History of serious adverse reaction(s) after any previous vaccination
  • Known or suspected allergy to active or inactive vaccine constituents
  • 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
  • Is unsuitable for participation in the trial or is not likely to comply with instructions as assessed by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CCBR

Aalborg, DK-9000, Denmark

Location

CCBR

Ballerup Municipality, DK-2750, Denmark

Location

CCBR

Vejle, DK-7100, Denmark

Location

Related Publications (1)

  • Lindgren LM, Tingskov PN, Justesen AH, Nedergaard BS, Olsen KJ, Andreasen LV, Kromann I, Sorensen C, Dietrich J, Thierry-Carstensen B. First-in-human safety and immunogenicity investigations of three adjuvanted reduced dose inactivated poliovirus vaccines (IPV-Al SSI) compared to full dose IPV Vaccine SSI when given as a booster vaccination to adolescents with a history of IPV vaccination at 3, 5, 12months and 5years of age. Vaccine. 2017 Jan 23;35(4):596-604. doi: 10.1016/j.vaccine.2016.12.027. Epub 2016 Dec 24.

    PMID: 28027810DERIVED

Study Officials

  • Line Markdanner Lindgren

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

November 13, 2014

Primary Completion

March 1, 2015

Study Completion

March 5, 2015

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(3)