Study of a Pandemic Influenza Vaccine in Children

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Murdoch Childrens Research Institute, Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

H5N1 pandemic influenza vaccine

Biological

Primary outcomes

Safety and immunogenicity

Sponsors and collaborators

Lead sponsor

Seqirus

Industry

Registry information

Official study title

Phase II Study of a Pandemic Influenza Vaccine in Children

Important dates

Study start: 2006
Study completion: 2007
First posted: Sep 1, 2006
Registry last updated: Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed