Influenza Infections and Infestations Influenza, virus not identified
Conditions
Interventions
Experimental arm:
Healthy children aged 36 months to 15 years in the intervention colonies will be immunised with inactivated influenza vaccine (VAXIGRIP vaccine). A 0.5 ml dose of the vaccine will b
Sponsors
McMaster University (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: There are two sets of participants in this trial: 1. Hutterites other than the healthy children who will be immunised. Although this category as a whole will be used to assess indirect benefit of the vaccine in the main analysis, Hutterites at high risk for influenza complications within this category will be assessed in a separate analysis. These are defined as anyone in one or more of the following groups: 1.1. Individuals aged greater than or equal to 65 years 1.2. Pregnant women 1.3. Children 23 months of age or less 1.4. Anyone with greater than or equal to one of the following conditions severe enough to require regular medical follow-up or hospital care: 1.4.1. Chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis, and asthma) 1.4.2. Diabetes mellitus and other metabolic diseases 1.4.3. Cancer 1.4.4. Immunodeficiency 1.4.5. Immunosuppression (due to underlying disease and/or therapy) 1.4.6. Renal disease 1.4.7. Anaemia 1.4.8. Haemoglobinopathy 1.4.9. Any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk of aspiration 2. Healthy children aged 36 months to 15 years who will be immunised as part of the intervention
Exclusion criteria
Exclusion criteria: 1. Hutterites other than the healthy children who will be immunised; there are no exclusion criteria for this category of participants 2. Healthy children aged 36 months to 15 years who will be immunised as part of the intervention: 2.1. Anaphylactic reaction to a previous dose of influenza vaccine 2.2. Anaphylactic reaction to hepatitis A vaccine 2.3. Anaphylactic reaction to neomycin 2.4. Known immunoglobulin E (IgE)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock 2.5. Guillain-Barre syndrome within eight weeks of a previous influenza vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory-confirmed influenza infection among Hutterite colony members other than the healthy children immunised as part of the intervention. Laboratory-confirmed influenza will be confirmed on the basis of at least one of the following: 1. Detection of viral ribonucleic acid (RNA) on the basis of reverse transcriptase polymerase chain reaction (PCR) 2. Isolation of influenza virus from nasopharyngeal (NP) specimens or throat specimens 3. Greater than or equal to four-fold rise in serum antibodies to circulating influenza strain antigens Serology will be taken at baseline and at the end of the flu season. NP swabs will be taken any time a participant reports two or more symptoms during in the surveillance period. Surveillance will start once there is two consecutive weeks of at least one positive flu in that health region. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Influenza-like illness 2. Courses of antimicrobial prescriptions 3. Physician-diagnosed otitis media 4. School or work related absenteeism 5. Physician visits for respiratory illness 6. Lower respiratory infection or pneumonia 7. Hospitalisation for lower respiratory infection or pneumonia 8. All cause hospitalisations 9. Deaths due to lower respiratory infection or pneumonia 10. All-cause deaths This information will be collected during the surveillance period when a participant reports two or more symptoms. The information will be collected on a respiratory information form by the nurse through interviewing the participants. | — |
Countries
Canada
Outcome results
None listed