Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given as a Booster at Age 15-18 Months

Study Overview
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Brief Summary
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This is a phase III assessing the safety and immunogenicity of adjuvanted the reduced dose inactivated polio vaccine, IPV-Al SSI given as a booster vaccination to infants who were previously immunised with primary vaccination of IPV-Al SSI or IPV SSI in the VIPV-07 trial at age 2, 4, and 6 months. The IPV-Al SSI vaccine will be given at the age of 15-18 months.

Detailed Description
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At Visit 1 (screening, blood sample, and vaccination), the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. Information on medical history, and concomitant medication are collected and a physical examination is performed and vital signs are measured (demographics data is captured from the VIPV-07 database). The health assessment of the subject will include measurement of height, weight, temperature, heart rate, respiratory rate (breathing) and a general physical examination (which can include skin, head, eyes, ears, nose, throat, heart, lungs, lymph nodes, abdomen, and the musculoskeletal system). A pre-vaccination blood sample is taken for polio antibody determinations. The subject is vaccinated with IPV-Al (and concomitant vaccine(s) according to national guidelines, if relevant) and subsequently observed for immediate adverse events 30 minutes after the vaccination. An eDiary, a thermometer and a ruler are handed out to the parent(s)/guardian(s) for measurements and recording of temperature, injection site reactions and solicited systemic adverse events (AEs). These activities are performed daily, starting on the day of the vaccination and the following 2 days and until resolved. Any other AEs are recorded in the eDiary as instructed by the trial staff. A contact to the parent(s)/guardian(s) via telephone will be made after the vaccination visit to remind and check if the parent(s)/guardian(s) have any questions regarding how to fill in the eDiary. At Visit 2 (blood sample and trial completion), 1 month after Visit 1, the eDiary is collected, adverse events and concomitant medications are recorded, a blood sample for poliovirus antibody determination is taken and the end of the trial page is completed. In addition to the trial vaccine, the trial subjects will receive concomitant routine childhood vaccinations. The trial vaccine is administered in the anterolateral aspect of the right thigh, whereas the other injectable childhood vaccines are administered in the left thigh.

Official Title
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Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI Given as a Booster Vaccination at the Age of 15-18 Months to Infants Previously Immunised With IPV-Al SSI or IPV SSI

Conditions
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Poliomyelitis

Intervention / Treatment
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* Biological: IPV-Al SSI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants having completed the VIPV-07 trial Healthy 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 granted access to the infant's trial related medical records Parent(s)/guardian(s), according to the local legal requirements, are likely to comply with trial procedures Exclusion Criteria: Previously vaccinated with OPV Previously vaccinated with IPV outside the VIPV-07 trial Known or suspected immunodeficiency (e.g. leukaemia or lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criterion Severe uncontrolled chronic disease (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol) Previous Yellow Fever vaccination Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling 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 Treatment with a product, which is likely to modify the immune response (e.g blood products and immunoglobulins) ≤ 3 months 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: 15 Months
Maximum Age: 18 Months

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPV-Al SSI<br>Single arm trial. All subjects will receive the IPV-Al SSI as booster vaccination | Biological: IPV-Al SSI<br>* IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. A single dose of the IPV-Al SSI will be given to infants age 15-18 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Booster effect ratiors of GMT | Booster effect (day 28 / day 0 titres), from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured before and one month after the booster vaccination | Change from Visit 1 (6-9 months post-3rd vaccination) to one month after booster vaccination (Visit 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rates before booster vaccination | Subjects with seroprotection (titre ≥ 8) against poliovirus types 1, 2 and 3 before the booster vaccination. | 6-9 months post-3rd vaccination | 
| Seroprotection rates after booster vaccination | Subjects with seroprotection (titre ≥ 8) against poliovirus types 1, 2 and 3 one month after the booster vaccination. | one month after booster vaccination | 
| GMT value before booster vaccination | Geometric mean antibody titres (GMTs) against poliovirus types 1, 2 and 3 before the booster vaccination. | 6-9 months post-3rd vaccination | 
| GMT value after booster vaccination | GMTs against poliovirus types 1, 2 and 3 one month after the booster vaccination. | one month after booster vaccination | 
| Number of adverse events | All adverse event | 6-9 months post-3rd vaccination and one month after booster vaccination | 
| Persistence (tite rates) of antibodies | Persistence of antibodies against poliovirus types 1, 2 and 3 in subjects previously im-munised with IPV-Al SSI or IPV SSI | 6-9 months post-3rd vaccination and one month after booster vaccination |