ClinicalTrials.gov
ClinicalTrials.gov Menu

Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00981513
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : August 19, 2011
Sponsor:
Information provided by:
The University of Hong Kong

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Influenza Virus Infection Influenza-like Illness Acute Respiratory Infection Biological: Trivalent live attenuated seasonal influenza vaccine Biological: Monovalent live attenuated pandemic influenza vaccine Biological: Saline Phase 4

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
Study Start Date : September 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Influenza vaccination
Live attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray
 Biological: Trivalent live attenuated seasonal influenza vaccine
One dose
Other Name: FluMist, MedImmune Vaccines, Inc.
Biological: Monovalent live attenuated pandemic influenza vaccine
One dose
Other Name: FluMist Novel H1N1, MedImmune Vaccines, Inc.
Placebo Comparator: Saline placebo
Saline nasal spray
 Biological: Saline
One dose
Other Name: Saline nasal spray


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981513


Locations
Hong Kong
The University of Hong Kong
Pokfulam, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Benjamin J Cowling, PhD The University of Hong Kong
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr Benjamin J. Cowling, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00981513     History of Changes
Other Study ID Numbers: BJC004.6
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Infection
Communicable Diseases
Influenza, Human
Virus Diseases
Respiratory Tract Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs