Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
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ClinicalTrials.gov Identifier: NCT00981513 |
Recruitment Status
:
Completed
First Posted
: September 22, 2009
Last Update Posted
: August 19, 2011
|
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Estimated Enrollment : | 6300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Direct and Indirect Benefits of Influenza Vaccination in Schools and Households |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]
- Influenza virus infection confirmed by RT-PCR [ Time Frame: One year ]
- Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology. [ Time Frame: One year ]
- Adverse events following vaccination [ Time Frame: 7 days ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981513
Hong Kong | |
The University of Hong Kong | |
Pokfulam, Hong Kong |
Principal Investigator: | Benjamin J Cowling, PhD | The University of Hong Kong |
Responsible Party: | Dr Benjamin J. Cowling, The University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00981513 History of Changes |
Other Study ID Numbers: |
BJC004.6 |
First Posted: | September 22, 2009 Key Record Dates |
Last Update Posted: | August 19, 2011 |
Last Verified: | August 2011 |
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 |