Clinical Trial: A Study to Gather Safety Data Following Administration of a Hib-containing Booster Vaccine in Children Aged Two to Five Years
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Study to Gather Safety Data Following Administration of a Hib-containing Booster Vaccine in Children Aged Two to Five Years
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.
Detailed Summary:
Medicines, including vaccines, are monitored by the Medicines and Healthcare Regulatory Agency (MHRA) using what is commonly known as the "yellow card system" where patients or healthcare professionals may submit notifications. This involves reporting any untoward medical event that it is suspected may be related to administration of the given medicine. Through this system concern has been raised about large local reactions, particularly extensive limb swelling (ESL) which is usually defined as an area more than or equal to 50mm, in young children in receipt of their pre−school booster. The preschool booster vaccine contains diphtheria (D), tetanus (T), pertussis (P) and inactivated polio vaccine (IPV). Most of the children about whom these yellow card safety reports have been submitted would have been primed with whole cell pertussis (wP) containing vaccines in infancy. In some cases reports have noted blistering and cellulitis in the vaccinated limb with antibiotic treatment prescribed. There is a recognised risk of ESL in a small proportion of children, 2−13%, following administration of a fourth or fifth dose of acellular−pertussis containing vaccine. In previous studies these local reactions fully resolved without treatment within a few days. Acellular pertussis (aP) containing vaccine has been used exclusively in the routine infant immunisation programme in teh UK since September 2004. The first children who received a primary immunisation course exclusively of aP containing vaccine will reach 3.5 years, the age at which their preschool booster will be given, from December 2007. This will be their fourth dose of the aP containing vaccine and therefore provides the opportunity to define with greater precision the incidence of ESL following vaccination in UK children with regard to primary immunisation history of aP vs the previously used whole cell pertussis (wP) vaccines. These children
Sponsor: Public Health England
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Public Health England
Dates:
Date Received: February 19, 2008
Date Started: December 2007
Date Completion:
Last Updated: November 2, 2010
Last Verified: January 2009
