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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1122-1928 | Other Identifier | WHO |
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The purpose of this study is to generate data to support the registration extension of IMOVAX Polio to be used in a sequential vaccination.
Primary objective:
Secondary objectives:
Study participants will be randomized to receive either 3 doses of a commercially available Oral Poliovirus Vaccine (OPV), or 1 dose of Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine IMOVAX Polio (IPV) followed by 2 doses of OPV, or 2 doses of IPV followed by 1 dose of OPV.
These vaccines will be administered at 2, 3 and 4 months of age as primary vaccination for the prevention of poliomyelitis. Participants will be followed up through their 18th- to 19th-month birthday.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Sequential 1): IPV-OPV-OPV | Experimental | Participants will receive 1 dose of Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV) followed by 2 doses of a commercially available Oral Poliovirus Vaccine (OPV) |
|
| Group B (Sequential 2): IPV-IPV-OPV | Experimental | Participants will receive 2 doses of Sanofi Pasteur's injectable Inactivated Poliovirus Vaccine (IPV) followed by 1 dose of a commercially available Oral Poliovirus Vaccine (OPV) |
|
| Group C (Reference): OPV-OPV-OPV | Experimental | Participants will receive 3 doses of a commercially available Oral Poliovirus Vaccine (OPV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio | Biological | 0.5 mL, Intramuscular + 1g dragee candy oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody titers ≥8 (1/dil) against each of the 3 poliovirus serotypes (types 1, 2 and 3) after the 3 dose primary vaccination series. | Antibodies to the vaccine antigens will be determined by a microneutralization assay. | 1 month post-dose 3 (primary vaccination series) |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of participants reporting solicited injection site and systemic reaction, and serious adverse events after each vaccination with Polio virus vaccine. | Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability. | Day 0 up to 17 months post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanning | Guangxi | 530028 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26407255 | Derived | Li RC, Li CG, Wang HB, Luo HM, Li YP, Wang JF, Ying ZF, Yu WZ, Shu JD, Wen N, Vidor E. Immunogenicity of Two Different Sequential Schedules of Inactivated Polio Vaccine Followed by Oral Polio Vaccine Versus Oral Polio Vaccine Alone in Healthy Infants in China. J Pediatric Infect Dis Soc. 2016 Sep;5(3):287-96. doi: 10.1093/jpids/piv017. Epub 2015 Apr 16. |
| Label | URL |
|---|---|
| Related Info | View source |
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|
| Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio | Biological | 0.5 mL, Intramuscular + 1g dragee candy oral dose |
|
|
| Live oral poliovirus type 1, 2 and 3 | Biological | 1g dragee candy, oral |
|
| Geometric mean titers and anti poliovirus 1,2 and 3 individual antibody titers | Day 0 and up to 16 months post-vaccination |
| 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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