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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Poliomyelitis

Intervention / Treatment
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* Biological: IPV-Al


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPV-Al AJV<br>One dose of 0.5 mL of IPV-Al AJV injected intramuscularly perpendicular to the skin in the RIGHT deltoid muscle. | Biological: IPV-Al<br>* adjuvanted reduced dose inactivated polio vaccine<br>* Other names: IPV-Al AJV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One month after administration of an additional dose of IPV-Al AJV |