NCT00370864

Brief Summary

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic. Children are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 19, 2016

Status Verified

November 1, 2008

First QC Date

August 30, 2006

Last Update Submit

July 17, 2016

Conditions

Influenza

Keywords

PandemicInfluenzaPreventionVaccinePrevention of Pandemic Influenza

Outcome Measures

Primary Outcomes (1)

  • Safety and immunogenicity

Interventions

H5N1 pandemic influenza vaccineBIOLOGICAL

Eligibility Criteria

Age6 Months - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children aged greater or equal to 6 months to less than 9 years
  • Normal gestation period

You may not qualify if:

  • History of clinically significant medical conditions
  • History of Guillain Barre syndrome or active neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Murdoch Childrens Research Institute

Melbourne, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Location

Related Publications (1)

  • Nolan T, Richmond PC, Formica NT, Hoschler K, Skeljo MV, Stoney T, McVernon J, Hartel G, Sawlwin DC, Bennet J, Ryan D, Basser RL, Zambon MC. Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children. Vaccine. 2008 Nov 25;26(50):6383-91. doi: 10.1016/j.vaccine.2008.08.046. Epub 2008 Sep 16.

    PMID: 18801398DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Terry M Nolan, Prof

    Murdoch Childrens Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

September 1, 2006

Study Completion

July 1, 2007

Last Updated

July 19, 2016

Record last verified: 2008-11

Locations

AU(2)