Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

The University of Hong Kong6,300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

6,300

Conditions

Influenza Virus Infection Influenza-like Illness Acute Respiratory Infection

Interventions

Trivalent live attenuated seasonal influenza vaccineBIOLOGICAL

One dose

Monovalent live attenuated pandemic influenza vaccineBIOLOGICAL

One dose

SalineBIOLOGICAL

One dose

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The University of Hong Kong

Pokfulam, Hong Kong

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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