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The purpose of this study is to investigate the use of a fourth fractional booster dose of sanofi pasteur's IMOVAX Polio injected intradermally (using the Mantoux technique) as booster dose between 15 to 18 months of age, in terms of immunogenicity and safety.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Will receive fractional doses of IPV Intradermally |
|
| Group B | Active Comparator | Will receive full doses of IPV Intramuscularly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated types 1, 2, and 3 poliovirus, D antigens | Biological | 0.1 mL, intradermal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination. | 30 days post-vaccination | |
| Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine | 30 days post-vaccination and entire study duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quezon City | Manila | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22153001 | Derived | Cadorna-Carlos J, Vidor E, Bonnet MC. Randomized controlled study of fractional doses of inactivated poliovirus vaccine administered intradermally with a needle in the Philippines. Int J Infect Dis. 2012 Feb;16(2):e110-6. doi: 10.1016/j.ijid.2011.10.002. Epub 2011 Dec 5. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Inactivated types 1, 2, and 3 poliovirus, D antigens | Biological | 0.5 mL, Intramuscular |
|
|
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| 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 |
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