NCT01425372

Evaluating Vaccine Responses in Healthy Infants Receiving Their Routine Primary Immunisation According to the Accelerated United Kingdom Schedule at 2, 3 and 4 Months

A Prospective Study to Evaluate the Immune Response of UK Infants Receiving the 13-valent Pneumococcal Conjugate Vaccine as Part of Their Routine Primary Immunisation Schedule at 2 and 4 Months

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Prof. Elizabeth Miller · Other Government
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

Streptococcus pneumoniae is a major cause of serious bacterial infections, particularly among young children. Over 30 different types of the pneumococcus germ can cause invasive disease, but 7 types (namely serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) are responsible for around 75% of cases in young children. A pneumococcal conjugate vaccine against these 7 serotypes (PCV7; Prevenar ®, Wyeth Vaccines) was introduced into the UK national immunisation programme in September 2006 and has resulted in a rapid reduction in pneumococcal disease caused by the 7 serotypes among both vaccinated children and older unvaccinated children and adults through herd immunity. By 2009, over half of all invasive pneumococcal cases in young children were caused by six other pneumococcal serotypes (1, 3, 5, 6A, 7F and 19A) that are included in a newly licensed 13 valent pneumococcal vaccine (PCV13; Prevenar 13®, Wyeth Vaccines). In April 2010, PCV13 replaced PCV7 in the UK immunisation programme with the aim of further reducing cases of invasive pneumococcal disease. The antibody responses induced by the 7 serotypes in both PCV13 and PCV7 have been shown to be comparable, but the protection offered by the additional 6 serotypes in PCV13 merits further study. Also, it is possible that the use of PCV13 instead of PCV7 may interfere with immune responses to other vaccines, such as Haemophilus influenzae serotype b (Hib), which are given to infants at the same time as PCV13. The proposed study will aim to collect one blood sample from infants after they receive their routine vaccinations at 2, 3 and 4 months in order to their measure immune responses to routine vaccines. The investigators hope that their results will help us better understand the added protection offered by the 13valent pneumococcal vaccine and ensure that children are adequately protected by the other vaccines they receive.

Detailed description

This study will aim to prospectively recruit infants in the first 6 months of life who are either due to receive or in the process of receiving their routine infant immunisation and request one blood sample one month after completing their primary immunisation schedule, which will be at around 5 months of age, if they fulfil the inclusion criteria for the study. NUMBER OF SUBJECTS AND DURATION OF STUDY A total of 200 infants will be recruited in two centres - Hertfordshire and Gloucestershire.

Conditions

• Streptococcus Pneumoniae

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-05-01
• Completion: 2013-06-01
• First posted: 2011-08-30
• Last updated: 2019-03-22

Locations

1 site across 1 country: United Kingdom