Acute Respiratory Infection, Influenza-like Illness, Influenza Virus Infection
Conditions
Brief summary
The purpose of this study is to determine the degree of indirect benefits to family members and classmates resulting from administration of influenza vaccine to children.
Interventions
BIOLOGICALTrivalent live attenuated seasonal influenza vaccine
One dose
BIOLOGICALMonovalent live attenuated pandemic influenza vaccine
One dose
BIOLOGICALSaline
One dose
Sponsors
The University of Hong Kong
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
* Hong Kong residents aged between 7 and 11 and their family members.
Exclusion criteria
* Children with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations. * Children receiving aspirin therapy or aspirin-containing therapy. * Children with asthma or active wheezing. * Children or family members with underlying immunocompromised condition or receiving immunosuppressive agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical influenza by self-reported symptoms, specifically defined as at least two of fever ≥37.8ºC, cough, headache, sore throat, aches or pains in muscles or joints | One year |
| Influenza virus infection confirmed by RT-PCR | One year |
Secondary
| Measure | Time frame |
|---|---|
| Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology. | One year |
| Adverse events following vaccination | 7 days |
Countries
Hong Kong
Outcome results
None listed