Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
This study has been completed.
Sponsor:
The University of Hong Kong
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00981513
First received: September 20, 2009
Last updated: August 18, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Virus Infection Influenza-like Illness Acute Respiratory Infection |
Biological: Trivalent live attenuated seasonal influenza vaccine Biological: Monovalent live attenuated pandemic influenza vaccine Biological: Saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Direct and Indirect Benefits of Influenza Vaccination in Schools and Households |
Resource links provided by NLM:
Further study details as provided by The University of Hong Kong:
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 [ Time Frame: One year ] [ Designated as safety issue: No ]
- Influenza virus infection confirmed by RT-PCR [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology. [ Time Frame: One year ] [ Designated as safety issue: No ]
- Adverse events following vaccination [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 6300 |
| Study Start Date: | September 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Influenza vaccination
Live attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray
|
Biological: Trivalent live attenuated seasonal influenza vaccine
One dose
Other Name: FluMist, MedImmune Vaccines, Inc.
Biological: Monovalent live attenuated pandemic influenza vaccine
One dose
Other Name: FluMist Novel H1N1, MedImmune Vaccines, Inc.
|
|
Placebo Comparator: Saline placebo
Saline nasal spray
|
Biological: Saline
One dose
Other Name: Saline nasal spray
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981513
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981513
Locations
| Hong Kong | |
| The University of Hong Kong | |
| Pokfulam, Hong Kong | |
Sponsors and Collaborators
The University of Hong Kong
Investigators
| Principal Investigator: | Benjamin J Cowling, PhD | The University of Hong Kong |
More Information
| Responsible Party: | Dr Benjamin J. Cowling, The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00981513 History of Changes |
| Other Study ID Numbers: | BJC004.6 |
| Study First Received: | September 20, 2009 |
| Last Updated: | August 18, 2011 |
| Health Authority: | Hong Kong: Institutional Review Board Hong Kong: Department of Health |
Additional relevant MeSH terms:
|
Infection Communicable Diseases Influenza, Human Virus Diseases Respiratory Tract Infections Orthomyxoviridae Infections |
RNA Virus Infections Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 28, 2016