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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | b-OPV, m-IPV HD and m-OPV2 |
|
| Group 2 | Active Comparator | b-OPV, t-IPV and m-OPV2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| b-OPV | Biological |
| ||
| m-OPV2 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Sáez, MD | Hospital Del Niño | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Niño | Panama City | Provincia de Panamá | Panama |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29304199 | Derived | Brickley EB, Strauch CB, Wieland-Alter WF, Connor RI, Lin S, Weiner JA, Ackerman ME, Arita M, Oberste MS, Weldon WC, Saez-Llorens X, Bandyopadhyay AS, Wright PF. Intestinal Immune Responses to Type 2 Oral Polio Vaccine (OPV) Challenge in Infants Previously Immunized With Bivalent OPV and Either High-Dose or Standard Inactivated Polio Vaccine. J Infect Dis. 2018 Jan 17;217(3):371-380. doi: 10.1093/infdis/jix556. | |
| 26719058 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 2, 2017 | |
| Reset | Aug 7, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 2, 2017 | Aug 7, 2018 |
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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|
| m-IPV HD | Biological |
|
| t-IPV | Biological |
|
| Derived |
| Saez-Llorens X, Clemens R, Leroux-Roels G, Jimeno J, Clemens SA, Weldon WC, Oberste MS, Molina N, Bandyopadhyay AS. Immunogenicity and safety of a novel monovalent high-dose inactivated poliovirus type 2 vaccine in infants: a comparative, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2016 Mar;16(3):321-30. doi: 10.1016/S1473-3099(15)00488-0. Epub 2015 Dec 21. |
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |