Back to resultsDirect and Indirect Benefits of Influenza Vaccination in Schools and Households
Primary Purpose
Influenza Virus Infection, Influenza-like Illness, Acute Respiratory Infection
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Trivalent live attenuated seasonal influenza vaccine
Monovalent live attenuated pandemic influenza vaccine
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Virus Infection
Eligibility Criteria
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.
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Influenza vaccination
Saline placebo
Arm Description
Live attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray
Saline nasal spray
Outcomes
Primary Outcome Measures
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
Influenza virus infection confirmed by RT-PCR
Secondary Outcome Measures
Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology.
Adverse events following vaccination
Full Information
NCT ID
NCT00981513
First Posted
September 20, 2009
Last Updated
August 18, 2011
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00981513
Brief Title
Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
Official Title
Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Virus Infection, Influenza-like Illness, Acute Respiratory Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Influenza vaccination
Arm Type
Active Comparator
Arm Description
Live attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray
Arm Title
Saline placebo
Arm Type
Placebo Comparator
Arm Description
Saline nasal spray
Intervention Type
Biological
Intervention Name(s)
Trivalent live attenuated seasonal influenza vaccine
Other Intervention Name(s)
FluMist, MedImmune Vaccines, Inc.
Intervention Description
One dose
Intervention Type
Biological
Intervention Name(s)
Monovalent live attenuated pandemic influenza vaccine
Other Intervention Name(s)
FluMist Novel H1N1, MedImmune Vaccines, Inc.
Intervention Description
One dose
Intervention Type
Biological
Intervention Name(s)
Saline
Other Intervention Name(s)
Saline nasal spray
Intervention Description
One dose
Primary Outcome Measure Information:
Title
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
Time Frame
One year
Title
Influenza virus infection confirmed by RT-PCR
Time Frame
One year
Secondary Outcome Measure Information:
Title
Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology.
Time Frame
One year
Title
Adverse events following vaccination
Time Frame
7 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin J Cowling, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Pokfulam
Country
Hong Kong
12. IPD Sharing Statement
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Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
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