Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00981513
First received: September 20, 2009
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Influenza virus infection confirmed by RT-PCR [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Adverse events following vaccination [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 6300
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Benjamin J. Cowling, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00981513     History of Changes
Other Study ID Numbers: BJC004.6
Study First Received: September 20, 2009
Last Updated: August 18, 2011
Health Authority: Hong Kong: Institutional Review Board
Hong Kong: Department of Health

Additional relevant MeSH terms:
Influenza, Human
Respiratory Tract Infections
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Infection

ClinicalTrials.gov processed this record on July 22, 2014