A Study to Gather Safety Data Following Administration of a Hib-containing Booster Vaccine in Children Aged Two to Five Years
DIPS
1 other identifier
observational
500
1 country
2
Brief Summary
This will be an observational study where parents/ guardians of children in receipt of their preschool booster will be approached for their child(ren) to take part. Following written informed consent the Vaccine Research Nurse will explain the purpose of the study and what would be involved. Participation will involve completion of a health diary for the week following vaccination to document how their child has been both in terms of local reactions and systemic symptoms as well as any visits to a doctor (GP or hospital). The nurse will telephone the family at 48-72 hours following vaccination to see how the child has been. Information about the vaccine given in the current campaign and vaccines administered in the infant schedule including date of administration, product and batch number will be recorded where available. Should any large local reactions be reported the nurse may visit the child to take a photograph to document and illustrate these - photographs will be taken without the child's face visible. Subjects will be recruited in two centres - Hertfordshire and Gloucestershire. Recruitment will start as soon as the necessary approvals are in place. Monthly reports of observed data will be submitted to the MHRA though the formal analysis will not be conducted until the end of the study. Recruitment figures and the incidence of ESLs will be reviewed on a six-monthly basis. At this point it is difficult to predict parental attitude to taking part, though from experience with recruitment in previous studies it is hoped this will be positive, so affording a large number of participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 19, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedMarch 22, 2019
January 1, 2009
February 19, 2008
March 20, 2019
Conditions
Keywords
Study Arms (1)
1
Children in receipt of a Hib containing vaccine at pre-school booster (3.5-6 years old).
Eligibility Criteria
Children in receipt of pre-school booster vaccinations (age 3.5-6 years)
You may qualify if:
- Child in receipt of the preschool booster vaccination or Menitorix under the Hib catchup campaign
- Written informed consent from a parent/ guardian
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Health Protection Agency
Gloucester, United Kingdom
Health Protection Agency
London, United Kingdom
Related Publications (1)
Southern J, Waight PA, Andrews N, Miller E. Extensive swelling of the limb and systemic symptoms after a fourth dose of acellular pertussis containing vaccines in England in children aged 3-6years. Vaccine. 2017 Jan 23;35(4):619-625. doi: 10.1016/j.vaccine.2016.12.017. Epub 2016 Dec 23.
PMID: 28017441BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Miller, MB BS FFPHM FRCPath
Public Health England
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
February 19, 2008
First Posted
February 28, 2008
Study Start
December 1, 2007
Last Updated
March 22, 2019
Record last verified: 2009-01