Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

NCT ID: NCT00981513

Last Updated: 2011-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza Virus Infection Influenza-like Illness Acute Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Influenza vaccination

Live attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray

Group Type ACTIVE_COMPARATOR

Trivalent live attenuated seasonal influenza vaccine

Intervention Type BIOLOGICAL

One dose

Monovalent live attenuated pandemic influenza vaccine

Intervention Type BIOLOGICAL

One dose

Saline placebo

Saline nasal spray

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type BIOLOGICAL

One dose

Interventions

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Trivalent live attenuated seasonal influenza vaccine

One dose

Intervention Type BIOLOGICAL

Monovalent live attenuated pandemic influenza vaccine

One dose

Intervention Type BIOLOGICAL

Saline

One dose

Intervention Type BIOLOGICAL

Other Intervention Names

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FluMist, MedImmune Vaccines, Inc. FluMist Novel H1N1, MedImmune Vaccines, Inc. Saline nasal spray

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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The University of Hong Kong

Principal Investigators

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Benjamin J Cowling, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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The University of Hong Kong

Pokfulam, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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BJC004.6

Identifier Type: -

Identifier Source: org_study_id

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