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| Name | Class |
|---|---|
| IWK Health Centre | OTHER |
| MCM Vaccines B.V. | INDUSTRY |
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To demonstrate the safety and immunogenicity of two mixed primary immunization schedules: Pediacel® at 2 and 4 months of age followed by one dose of Infanrix™ IPV/Hib at 6 months of age; and, Infanrix™ IPV/Hib at 2 months of age, followed by Pediacel® at 4 and 6 months of age.
Immunogenicity will be evaluated using the following:
Serological outcome measures will be assessed on day 0 (visit 1) and 28-42 days after the 3rd dose of the primary series for both groups:
Safety will be evaluated using the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Pediacel® at 2 and 4 months of age followed by Infanrix™-IPV/Hib at 6 months. |
|
| Group 2 | Active Comparator | Infanrix™-IPV/Hib at 2 months of age followed by Pediacel® at 4 and 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediacel® and Infanrix™-IPV/Hib | Biological | 0.5 mL IM at 2,4 and 6 months of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive statistics will be used to summarize the safety and immunogenicity of the two mixed primary immunization schedules. | serology at 2 and 7 months of age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Langley, MD | Dalhousie University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Center for Vaccinology | Halifax | Nova Scotia | B3K 6R8 | Canada | ||
| MUHC- Vaccine Study Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22173143 | Derived | Langley JM, Halperin SA, Rubin E, White C, McNeil S, Mutch J, Mackinnon-Cameron D, Smith B. Safety and immunogenicity of 2 mixed primary infant immunization schedules of pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, and Haemophilus influenzae Type B vaccines at 2, 4, and 6 months of age: a randomized controlled trial. Pediatr Infect Dis J. 2012 Feb;31(2):189-92. doi: 10.1097/INF.0b013e318242462a. |
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| ID | Term |
|---|---|
| C541234 | diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine |
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| Pierrefonds |
| Quebec |
| H9H 4Y6 |
| Canada |