A Study to Gather Safety Data Following Administration of a Hib-containing Booster Vaccine in Children Aged Two to Five Years (DIPS)

This study has been completed.
Sponsor:
Information provided by:
Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00625118
First received: February 19, 2008
Last updated: November 2, 2010
Last verified: January 2009
  Purpose

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.


Condition
Haemophilus Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Gather Safety Data Following Administration of a Hib-containing Booster Vaccine in Children Aged Two to Five Years

Resource links provided by NLM:


Further study details as provided by Health Protection Agency, United Kingdom:

Estimated Enrollment: 500
Study Start Date: December 2007
Groups/Cohorts
1
Children in receipt of a Hib containing vaccine at pre-school booster (3.5-6 years old).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   42 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children in receipt of pre-school booster vaccinations (age 3.5-6 years)

Criteria

Inclusion Criteria:

  • Child in receipt of the preschool booster vaccination or Menitorix under the Hib catchup campaign
  • Written informed consent from a parent/ guardian

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625118

Locations
United Kingdom
Health Protection Agency
Gloucester, United Kingdom
Health Protection Agency
London, United Kingdom
Sponsors and Collaborators
Health Protection Agency, United Kingdom
Investigators
Principal Investigator: Elizabeth Miller, MB BS FFPHM FRCPath Health Protection Agency, United Kingdom
  More Information

Additional Information:
No publications provided

Responsible Party: Prof Elizabeth Miller, Health Protection Agency
ClinicalTrials.gov Identifier: NCT00625118     History of Changes
Other Study ID Numbers: DIPS
Study First Received: February 19, 2008
Last Updated: November 2, 2010
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Health Protection Agency, United Kingdom:
Hib conjugate vaccine
reactogenicity
local reactions
systemic symptoms

Additional relevant MeSH terms:
Haemophilus Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014