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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

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

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

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

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

NCT ID

NCT04448132

First Posted

June 23, 2020

Last Updated

June 21, 2021

Sponsor

AJ Vaccines A/S

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

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