Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
Phase 4
Completed
- Conditions
- Influenza Virus InfectionInfluenza-like IllnessAcute Respiratory Infection
- Registration Number
- NCT00981513
- Lead Sponsor
- The University of Hong Kong
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6300
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
The University of Hong Kong
🇭🇰Pokfulam, Hong Kong
The University of Hong Kong🇭🇰Pokfulam, Hong Kong