Retrospective safety survey of 2011 seasonal influenza vaccine (Fluarix Registered Trademark (R)) in New Zealand (NZ) children aged 6 months to 8 years

Retrospective safety survey of 2011 seasonal influenza vaccine (Fluarix (R)) in NZ children aged 6 months to 8 years

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000872932

Enrollment

400

Registered

2011-08-16

Start date

2011-07-11

Completion date

2011-08-26

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study of children who received 2011 influenza vaccine, is to ensure that the safety profile of this year’s vaccine is within expectations. The aim is to survey 250 parents of children aged 6 months to five years inclusive and 150 parents of children aged six years to eight years inclusive, who received the 2011 influenza vaccine. To determine the rates of febrile events in young children aged 6 months to 8 years inclusive within 24 hours of receipt of any dose of 2011 Fluarix (R)

Interventions

This study aims to survey 400 parents for their recall of febrile and other reactions following their child’s vaccination with the 2011 seasonal influenza vaccine manufactured by GSK (Fluarix). This will be a retrospective telephone survey of parents of infants and children, who received 2011 Fluarix influenza vaccine, and will be conducted by the practice nurses, in the general practice who administered the vaccine to the infants or children. Recruitment is expected to take 2 months, or until

Eligibility

Sex/Gender

All

Age

6 Months to 8 Years

Healthy volunteers

Yes

Inclusion criteria

All infants and children aged 6 months to 8 years inclusive receiving seasonal influenza vaccine during the study period.

Exclusion criteria

Parents or caregivers unable to speak conversational English or unavailable by telephone.

Outcome results