Status:
COMPLETED
Evaluating Vaccine Responses in Healthy Infants Receiving Their Routine Primary Immunisation According to the Accelerated United Kingdom Schedule at 2, 3 and 4 Months
Lead Sponsor:
Prof. Elizabeth Miller
Conditions:
Streptococcus Pneumoniae
Eligibility:
All Genders
Up to 6 years
Brief 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 (...
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 ...
Eligibility Criteria
Inclusion
- Male or female infants born at term (at least 37 weeks gestation) aged \<6 months:
- With written informed consent obtained from the parent or legal guardian of the infant to participate in the study and to allow the infant's General Practitioner (GP) to be informed of participation in the study and be contacted, if required, for confirmation of the vaccination history
- Who have received all their primary immunisations in the 1st 6 months of life, including:
- 3 doses of Pediacel®
- 2 doses of Prevenar13®, with the 1st dose given at 6-12 weeks of age and the 2nd dose at 8-12 weeks after the 1st dose
- 2 doses of any MenC vaccine
- Do not fulfil any of the Exclusion Criteria
Exclusion
- Participant may not be included in the study if any of the following apply:
- History of invasive Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease
- Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV)
- Bleeding disorders and/or prolonged bleeding time
- Major congenital defects or chronic disease
- Premature birth (\<37 weeks gestation at birth)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01425372
Start Date
November 1 2010
End Date
June 1 2013
Last Update
March 22 2019
Active Locations (1)
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1
Multiple GP surgeries
Hertfordshire and Gloucstershire, United Kingdom