Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

August 18, 2011 updated by: The University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Pokfulam, Hong Kong
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • FluMist, MedImmune Vaccines, Inc.
Biological: Monovalent live attenuated pandemic influenza vaccine
One dose
Other Names:
  • FluMist Novel H1N1, MedImmune Vaccines, Inc.
Placebo Comparator: Saline placebo
Saline nasal spray
Biological: Saline
One dose
Other Names:
  • Saline nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One year
Influenza virus infection confirmed by RT-PCR
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology.
Time Frame: One year
One year
Adverse events following vaccination
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

September 20, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Estimate)

August 19, 2011

Last Update Submitted That Met QC Criteria

August 18, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJC004.6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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