Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

Phase 4

Completed

• Conditions: Influenza Virus Infection; Influenza-like Illness; Acute Respiratory Infection
• Interventions: Biological: Trivalent live attenuated seasonal influenza vaccine; Biological: Saline; Biological: Monovalent live attenuated pandemic influenza vaccine

• Registration Number: NCT00981513
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-20
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-18
• Last Update Posted: 2011-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Influenza vaccination	Trivalent live attenuated seasonal influenza vaccine	Live attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray
Influenza vaccination	Monovalent live attenuated pandemic influenza vaccine	Live attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray
Saline placebo	Saline	Saline nasal spray

Primary Outcome Measures

Name	Time	Method
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	One year
Influenza virus infection confirmed by RT-PCR	One year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Pokfulam, Hong Kong