Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life

Study Overview
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Brief Summary
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Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus vaccine (b-OPV) to infants early in life

Official Title
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Phase II, Observer-blind, Randomized Study on the Safety, Reactogenicity, Immunogenicity and Impact on Intestinal Shedding of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) or a Single Dose of Standard Trivalent Inactivated Poliovirus Vaccine (t-IPV) When Given Concomitantly With the Third Dose of Bivalent Oral Poliovirus Vaccine (b-OPV) to Infants Early in Life

Conditions
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Polio

Intervention / Treatment
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* Biological: b-OPV
* Biological: m-OPV2
* Biological: m-IPV HD
* Biological: t-IPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 6 weeks (-7 to +14 days). Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination. Written informed consent obtained from 1 or 2 parents or legal guardian as per Panama regulations. Exclusion Criteria: Previous vaccination against poliovirus. Low birth weight (BW <2,500 gm). Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection. Family history of congenital or hereditary immunodeficiency. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). Known allergy to any component of the study vaccines. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.). Member of the subject's household (living in the same house or apartment unit) has received OPV in the last 3 months. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 6 Weeks

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>b-OPV, m-IPV HD and m-OPV2 | Biological: b-OPV<br> <br> Biological: m-OPV2<br> <br> Biological: m-IPV HD<br> <br> |
| Active Comparator: Group 2<br>b-OPV, t-IPV and m-OPV2 | Biological: b-OPV<br> <br> Biological: m-OPV2<br> <br> Biological: t-IPV<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | To assess and compare descriptively the safety of a single dose of a m-IPV2 HD vaccine in healthy infants to that of a licensed t-IPV vaccine when given concomitantly with the third dose of b-OPV measured by the incidence of serious adverse events (SAEs) and important medical events (IMEs) from the day of vaccine administration until day of last visit at study week 15 (  week 21 of life). | 6 weeks | 
| Efficacy | To determine whether 1 dose of a m-IPV2 HD vaccine given to infants is superior to 1 dose of t-IPV given at study week 8 ( 14 weeks of age) in inducing a humoral immune response to type 2 poliovirus when measured as seroconversion to type 2 poliovirus (type-specific titers ≥1:8 and >4-fold over expected levels of maternally-derived antibody) and as median titers four weeks later at study week 12 (  18 weeks of age). | 4 weeks |