Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

Acute Respiratory Infection Clinical Trial

Official title:

Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981513
• Other study ID #: BJC004.6
• Status: Completed
• Phase: Phase 4
• First received: September 20, 2009
• Last updated: August 18, 2011
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: August 2011
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Institutional Review BoardHong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6300
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Infection
• Influenza Virus Infection
• Influenza, Human
• Influenza-like Illness
• Respiratory Tract Infections
• Virus Diseases

Intervention

Biological:
• Trivalent live attenuated seasonal influenza vaccine
One dose
• Monovalent live attenuated pandemic influenza vaccine
One dose
• Saline
One dose

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Pokfulam

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Influenza virus infection confirmed by RT-PCR		One year	No
Secondary	Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology.		One year	No
Secondary	Adverse events following vaccination		7 days	Yes