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Evaluation of Persistence of Immunity in 4-year-old Children Previously Immunised With IPV-Al AJV (Picovax®)

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 4
Locations
Panama
Study Type
Interventional
Intervention
IPV-Al
Sponsored by
AJ Vaccines A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

4 Years - 4 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Children that have been vaccinated with IPV-Al AJV in the VIPV-07 and VIPV-07 E1 trials and have completed these trials
  2. Healthy, as assessed from medical history and physical examination
  3. Parent(s)/guardian(s), according to the local legal requirements, have been properly informed about the trial and have signed the informed consent form
  4. Parent(s)/guardian(s), according to the local legal requirements, have been granted access to the child´s trial related medical records
  5. Parent(s)/guardian(s), according to the local legal requirements, are likely to comply with trial procedures

Exclusion Criteria:

  1. Previous vaccination with OPV
  2. Previous vaccination with IPV outside the VIPV-07 and VIPV-07 E1 trials
  3. Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV is not an exclusion criterion.
  4. Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
  5. Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde and/or 2-phenoxy-ethanol)
  6. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
  7. Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial period
  8. Participating in another interventional clinical trial
  9. Not suitable for inclusion in the opinion of the investigator

Sites / Locations

  • Cevaxim

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IPV-Al AJV

Arm Description

One dose of 0.5 mL of IPV-Al AJV injected intramuscularly perpendicular to the skin in the RIGHT deltoid muscle.

Outcomes

Primary Outcome Measures

Seroprotection (titer ≥8) against poliovirus types 1, 2 and 3
Individual serum titers against poliovirus types 1, 2 and three will be measured in collected serum samples

Secondary Outcome Measures

Full Information

First Posted
June 23, 2020
Last Updated
June 21, 2021
Sponsor
AJ Vaccines A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04448132
Brief Title
Evaluation of Persistence of Immunity in 4-year-old Children Previously Immunised With IPV-Al AJV (Picovax®)
Official Title
Evaluation of the Persistence of the Immunity in 4-year-old Children Previously Immunised With an Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al AJV (Picovax®) by Measuring the Response to an Additional Dose of IPV-Al AJV
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
May 3, 2021 (Actual)
Study Completion Date
May 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AJ Vaccines A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have been vaccinated with IPV-Al AJV at 2, 4, 6 and 15 18 months of age in previous trials. Levels of antibodies against poliovirus types 1, 2 and 3 after immunisation with IPV Al AJV will be measured in the trial subjects at the age of 4 years. An additional IPV-Al AJV dose (investigational vaccine) will be administered and the booster response to IPV-Al AJV will be investigated one month after administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPV-Al AJV
Arm Type
Experimental
Arm Description
One dose of 0.5 mL of IPV-Al AJV injected intramuscularly perpendicular to the skin in the RIGHT deltoid muscle.
Intervention Type
Biological
Intervention Name(s)
IPV-Al
Other Intervention Name(s)
Picovax®, IPV-Al AJV
Intervention Description
adjuvanted reduced dose inactivated polio vaccine
Primary Outcome Measure Information:
Title
Seroprotection (titer ≥8) against poliovirus types 1, 2 and 3
Description
Individual serum titers against poliovirus types 1, 2 and three will be measured in collected serum samples
Time Frame
One month after administration of an additional dose of IPV-Al AJV

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children that have been vaccinated with IPV-Al AJV in the VIPV-07 and VIPV-07 E1 trials and have completed these trials Healthy, as assessed from medical history and physical examination Parent(s)/guardian(s), according to the local legal requirements, have been properly informed about the trial and have signed the informed consent form Parent(s)/guardian(s), according to the local legal requirements, have been granted access to the child´s trial related medical records Parent(s)/guardian(s), according to the local legal requirements, are likely to comply with trial procedures Exclusion Criteria: Previous vaccination with OPV Previous vaccination with IPV outside the VIPV-07 and VIPV-07 E1 trials Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV is not an exclusion criterion. Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde and/or 2-phenoxy-ethanol) Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial period Participating in another interventional clinical trial Not suitable for inclusion in the opinion of the investigator
Facility Information:
Facility Name
Cevaxim
City
Panama city
Country
Panama

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36064670
Citation
Saez-Llorens X, Chan M, DeAntonio R, Petersen T, Olesen C, Jensen JS, Sorensen C, Ekstrand LM, Czort MK, Kristensen HH, Thulstrup N, Christoffersen DB. Persistence of protective anti-poliovirus antibody levels in 4-year-old children previously primed with Picovax(R), a trivalent, aluminium-adjuvanted reduced dose inactivated polio vaccine. Vaccine. 2022 Sep 22;40(40):5835-5841. doi: 10.1016/j.vaccine.2022.06.084. Epub 2022 Sep 3.
Results Reference
derived

Learn more about this trial

Evaluation of Persistence of Immunity in 4-year-old Children Previously Immunised With IPV-Al AJV (Picovax®)

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