None listed
Conditions
Brief summary
Influenza is a viral illness that causes much social disruption. It causes serious complications in young children including hospitalisation. Children in child care settings are more likely to be infected. Influenza vaccination can help prevent influenza in adults but data are lacking in young children. This study will determine both direct child benefits (protection, continuity of day care) and indirect benefits of influenza vaccination in reduced work absence (staff, parents), illness in the extended family. The study also measures the social and economic impact of influenza vaccination.
Interventions
An randomised controlled trial of trivalent inactivated influenza vaccine (Registered Trademark: VAXIGRIP Junior, Sanofi Pasteur; administered via intramuscular injection. 0.5ml used for subjects just turned 3 years of age whereas 0.25ml will be used for under 3 years of age), using Hepatitis A vaccine (HAV, Registered Trademark: VAQTA Paediatric, CSL, 25 units of virus protein) as the control at a ratio of 1:1. Frequency of administration would be either once or twice depending on subjects’ pre
An randomised controlled trial of trivalent inactivated influenza vaccine (Registered Trademark: VAXIGRIP Junior, Sanofi Pasteur; administered via intramuscular injection. 0.5ml used for subjects just turned 3 years of age whereas 0.25ml will be used for under 3 years of age), using Hepatitis A vaccine (HAV, Registered Trademark: VAQTA Paediatric, CSL, 25 units of virus protein) as the control at a ratio of 1:1. Frequency of administration would be either once or twice depending on subjects’ previous vaccination. The approximate duration between each vaccine Vaccination would 4 weeks. Will start from April to July.
Sponsors
Australian Research Council
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
6 Months to 48 Months
Healthy volunteers
Yes
Inclusion criteria
Male or female aged greater than or equal to 6 months to <48months at 1st march 2011; who will comply with the requirements of the protocol (e.g. completion of the diaries, return for the follow-up visit). The parent’s/guardian’s ability to understand English is sufficient not to impede the ability to give properly informed consent
Exclusion criteria
Systemic hypersensitivity to egg proteins, chicken proteins, or any of the vaccine components for the vaccine group. Unstable chronic illness; Known history of Guillain-Barre Syndrome; Plans to enter another clinical trial, or receive an investigational product after receiving vaccine for this trial any time before 31 October 2010; Thrombocytopenia or bleeding disorder and History of psychiatric disorders in the parent/guardian providing consent
Outcome results
None listed