A prospective study to evaluate the immune responses of UK infants to their routine 12-month booster vaccines following receipt of different meningococcal capsular group C (MenC) conjugate vaccines as part of their primary immunisation schedule (code: P13BOOST)

Health Protection Agency (UK)0 sites200 target enrollmentFebruary 12, 2013

Overview

No summary available.

Registry

who.int

Start Date

February 12, 2013

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Sponsor

Health Protection Agency (UK)

•Male or female infants:
•1\. 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
•2\. Who have received all their primary immunisations by the time they are 6 months old, including:
•2\.1\. Two doses of any MenC vaccine, with a 3\-8 week interval be\-tween the first and second dose, with the vaccine product identified by product name or batch number from either the parent\-held ?Red Book? or the GP records
•2\.2\. Who are available for their routine 12\-month booster vaccines and both blood tests as described in Study Schedule (Section 6\.2\)
•2\.3\. Do not fulfill any of the exclusion criteria

•Participant may not be included in the study if any of the following apply:
•1\. History of invasive Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease
•2\. Confirmed or suspected immunosuppression or immunodeficiency (including HIV)
•3\. Receipt of a meningococcal quadrivalent conjugate vaccine prior to the 12\-month booster
•4\. Bleeding disorders and/or prolonged bleeding time
•5\. Major congenital defects or chronic disease