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OpenTrials
Completed

NCT Number: NCT00981513

Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

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.

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Key information

Conditions

Influenza Virus Infection Acute Respiratory Infection Influenza-like Illness

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Hong Kong

Pokfulam, Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trivalent live attenuated seasonal influenza vaccine

Biological

One dose

Other names: FluMist, MedImmune Vaccines, Inc.

Monovalent live attenuated pandemic influenza vaccine

Biological

One dose

Other names: FluMist Novel H1N1, MedImmune Vaccines, Inc.

Saline

Biological

One dose

Other names: Saline nasal spray

Primary outcomes

  1. 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

  2. Influenza virus infection confirmed by RT-PCR

    Time frame: One year

Secondary outcomes

  1. Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology.

    Time frame: One year

  2. Adverse events following vaccination

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 22, 2009
Registry last updated
Aug 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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