NCT00981513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

August 19, 2011

Status Verified

August 1, 2011

Enrollment Period

1.2 years

First QC Date

September 20, 2009

Last Update Submit

August 18, 2011

Conditions

Influenza Virus InfectionInfluenza-like IllnessAcute Respiratory Infection

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Influenza vaccination

ACTIVE COMPARATOR

Live attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray

Biological: Trivalent live attenuated seasonal influenza vaccineBiological: Monovalent live attenuated pandemic influenza vaccine

Saline placebo

PLACEBO COMPARATOR

Saline nasal spray

Biological: Saline

Interventions

Trivalent live attenuated seasonal influenza vaccineBIOLOGICAL

One dose

Also known as: FluMist, MedImmune Vaccines, Inc.
Influenza vaccination
Monovalent live attenuated pandemic influenza vaccineBIOLOGICAL

One dose

Also known as: FluMist Novel H1N1, MedImmune Vaccines, Inc.
Influenza vaccination
SalineBIOLOGICAL

One dose

Also known as: Saline nasal spray
Saline placebo

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hong Kong residents aged between 7 and 11 and their family members.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Pokfulam, Hong Kong

Location

MeSH Terms

Interventions

FluMistSodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Benjamin J Cowling, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2009

First Posted

September 22, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 19, 2011

Record last verified: 2011-08

Locations

HK(1)