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| Name | Class |
|---|---|
| University of Calgary | OTHER |
| University of Saskatchewan | OTHER |
This study is a randomized controlled trial (RCT) comparing adjuvanted influenza vaccine (AV) to unadjuvanted inactivated influenza vaccine (IIV). Children in Hutterite colonies in Alberta and Saskatchewan will receive AV or IIV. The goal of this study is to determine whether the AV vaccine, can provide increased community-wide protection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvanted Influenza Vaccine | Experimental | Fluad. A 0.25 ml intramuscular dose of the vaccine will be administered to children aged from 6 months to less than 36 months and a 0.5ml dose will be administered to children aged from 36 months to 6 years. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.25 ml dose of the vaccine four weeks following the first vaccine as per influenza immunization recommendations if they are aged between 6 months and less than 36 months or a second dose of 0.5ml if they are aged from 36 months to 6 years. |
|
| Quadrivalent Influenza Vaccine | Active Comparator | Fluzone. A 0.5 ml dose of the vaccine will be administered intramuscularly. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.5 ml dose of the influenza vaccine four weeks following the first vaccine as per influenza immunization recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluad | Biological |
| ||
| Fluzone |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory-confirmed influenza infection | Up to 3 years |
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Group A: Receive Intervention
Inclusion Criteria:
-Healthy children aged 6 months to 72 months
Exclusion Criteria:
Group B:
Inclusion Criteria:
Exclusion Criteria:
Group C:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Loeb, MD, MSc. | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8S 4K1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38077624 | Derived | Switzer C, Verschoor CP, Pullenayegum E, Singh P, Loeb M. Adjuvant-attenuated symptom severity of influenza infections in vaccinated children. Infect Med (Beijing). 2022 Sep 15;1(3):163-170. doi: 10.1016/j.imj.2022.09.002. eCollection 2022 Sep. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C478243 | fluad vaccine |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |