NCT00792051

Brief Summary

While immunisation of school-age children against influenza is not recommended in Hong Kong, past experience in Japan and elsewhere suggests that immunisation of children may protect the wider community through its indirect transmission-limiting impact as well as the direct immunologic protection afforded vaccinated children themselves. We aim to assess whether vaccinating children against influenza protects vaccinees as well as their household contacts from infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

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, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

2.2 years

First QC Date

November 13, 2008

Last Update Submit

December 29, 2014

Conditions

Influenza Virus Infection

Keywords

influenzavaccinationchildrenInfluenza-like illness

Outcome Measures

Primary Outcomes (1)

  • The proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms.

    nine months

Study Arms (2)

1

ACTIVE COMPARATOR

Influenza vaccine

Biological: Inactivated influenza vaccine

2

PLACEBO COMPARATOR
Biological: Saline

Interventions

Inactivated influenza vaccineBIOLOGICAL

0.5ml intramuscular single dose

Also known as: VAXIGRIP®, Sanofi Pasteur
1
SalineBIOLOGICAL

0.5ml intramuscular, one dose

2

Eligibility Criteria

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

You may qualify if:

  • All vaccinees must be Hong Kong residents aged between 6 and 17.

You may not qualify if:

  • Vaccinees should not be allergic or hypersensitive to the active substances or components (eggs, chicken proteins, formaldehyde, neomycin, etc.) used in the vaccines or where vaccination is otherwise contraindicated. Subjects should not have an underlying immunocompromised condition or be receiving immunosuppressive agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (3)

  • Cowling BJ, Ng S, Ma ES, Fang VJ, So HC, Wai W, Cheng CK, Wong JY, Chan KH, Ip DK, Chiu SS, Peiris JS, Leung GM. Protective efficacy against pandemic influenza of seasonal influenza vaccination in children in Hong Kong: a randomized controlled trial. Clin Infect Dis. 2012 Sep;55(5):695-702. doi: 10.1093/cid/cis518. Epub 2012 Jun 5.

    PMID: 22670050RESULT

  • Cowling BJ, Ng S, Ma ES, Cheng CK, Wai W, Fang VJ, Chan KH, Ip DK, Chiu SS, Peiris JS, Leung GM. Protective efficacy of seasonal influenza vaccination against seasonal and pandemic influenza virus infection during 2009 in Hong Kong. Clin Infect Dis. 2010 Dec 15;51(12):1370-9. doi: 10.1086/657311. Epub 2010 Nov 10.

    PMID: 21067351RESULT

  • Cowling BJ, Perera RA, Fang VJ, Chan KH, Wai W, So HC, Chu DK, Wong JY, Shiu EY, Ng S, Ip DK, Peiris JS, Leung GM. Incidence of influenza virus infections in children in Hong Kong in a 3-year randomized placebo-controlled vaccine study, 2009-2012. Clin Infect Dis. 2014 Aug 15;59(4):517-24. doi: 10.1093/cid/ciu356. Epub 2014 May 13.

    PMID: 24825868DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigripSodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

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
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 17, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

CN(1)