Influenza
Conditions
Brief summary
There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with LAIV can provide increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.
Detailed description
The goal of this study is to test whether immunizing children in Hutterite colonies with LAIV can significantly reduce laboratory-confirmed influenza in the entire community compared to TIV. We hypothesize that ≥70% uptake of LAIV compared to a similar uptake of TIV among healthy children and adolescents will reduce laboratory-confirmed influenza in LAIV colonies by 50% compared to TIV colonies. Other specific objectives are to determine if LAIV reduces influenza in the healthy children and adolescents immunized and if LAIV reduces the following relative to TIV in all participants: influenza-like illness, antimicrobial prescriptions, physician-diagnosed otitis media, school or work-related absenteeism, physician visits for respiratory illness, lower respiratory infection, pneumonia, hospitalizations, and death. We will assess reactogenicity in both study groups.
Interventions
BIOLOGICALTrivalent Inactivated Vaccine
Influenza vaccination, 0.5 ml dose 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 four weeks later.
BIOLOGICALLive Attenuated Influenza Vaccine
Influenza vaccination, 0.2 ml dose administered intranasally. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.2 ml dose of the vaccine four weeks later.
Sponsors
Canadian Institutes of Health Research (CIHR)
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Group A: Inclusion criteria: * healthy children and adolescents aged 36 months to 15 years who will be immunized as part of the intervention.
Exclusion criteria
1. anaphylactic reaction to a previous dose of LAIV or TIV 2. known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock 3. history of asthma 4. medically diagnosed or treated wheezing within 42 days before enrollment 5. Guillain-Barré syndrome within eight weeks of a previous influenza vaccine 6. anaphylactic reaction to gentamicin 7. anaphylactic reaction to gelatin 8. anaphylactic reaction to neomycin 9. anaphylactic reaction to arginine 10. pregnancy 11. household contact who is severely immunocompromised being cared for in a protective environment (i.e hematopoietic stem cell transplant) 12. use of aspirin or salicylate-containing products within 30 days before enrollment. Group B: Inclusion Criteria * other Hutterite community members that are not in Group A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory-confirmed influenza infection. | up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Physician diagnosed otitis media. | December to June each year for 3 years. |
| Antimicrobial prescriptions. | December to June each year for 3 years. |
| School or work related absenteeism. | December to June each year for 3 years. |
| Physician visits for respiratory illness. | December to June each year for 3 years. |
| Influenza like illness. | December to June each year for 3 years. |
| Hospitalization for lower respiratory infection or pneumonia. | December to June each year for 3 years. |
| All cause hospitalizations. | December to June each year for 3 years. |
| Deaths due to lower respiratory infections or pneumonia. | December to June each year for 3 years. |
| All cause deaths. | December to June each year for 3 years. |
| Lower respiratory infection or pneumonia. | December to June each year for 3 years. |
Countries
Canada
Outcome results
None listed