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The present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated Poliomyelitis vaccine (IMOVAX) | Biological | Fractional dose (1/5th) 0.1 mL, intradermally |
|
| Measure | Description | Time Frame |
|---|---|---|
| The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination | 1 Month Post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination Safety: To describe in each group the safety after each dose of the study vaccines | 1 Month post-vaccination |
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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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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| D011054 | Poliovirus Vaccine, Inactivated |
| D011819 | Rabies Vaccines |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D015164 | Vaccines, Inactivated |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D023321 | Poliovirus Vaccines |
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| Inactivated Poliomyelitis vaccine (IMOVAX) | Biological | A full dose, 0.5 mL, intramuscular |
|
|
| 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 |
| D014765 |
| Viral Vaccines |