Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

This study has been completed.

Sponsor:

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

History of Changes

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:

MedlinePlus related topics: Flu

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 ] [ 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


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

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

No publications provided


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:


Influenza, Human Respiratory Tract Infections Infection Orthomyxoviridae Infections	RNA Virus Infections Respiratory Tract Diseases Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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