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Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00981513

First Posted: September 22, 2009

Last Update Posted: August 19, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

The University of Hong Kong

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 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

Resource links provided by NLM:

MedlinePlus related topics: Flu Flu Shot

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

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 ]
Influenza virus infection confirmed by RT-PCR [ Time Frame: One year ]

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 ]
Adverse events following vaccination [ Time Frame: 7 days ]


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

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
First Submitted:	September 20, 2009
First Posted:	September 22, 2009
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

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