A phase IV, single centre, open-label study to investigate the persistence of antibodies six years after priming immunisation with Meningococcal C conjugate vaccine and induction of long term immunological memory by assessing persistence of memory B cells and response to the Hib-MenC (Menitorix®) vaccine, in healthy children six to 12 years of age

niversity of Oxford (UK)0 sites250 target enrollmentSeptember 4, 2006

ConditionsMeningococcal C and Haemophilus influenzae type B diseases Infections and Infestations

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Meningococcal C and Haemophilus influenzae type B diseases
Sponsor: niversity of Oxford (UK)
Enrollment: 250
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 4, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity of Oxford (UK)

Eligibility Criteria

Inclusion Criteria

•1\. Participant?s parent or legally authorised representative is willing and able to give written informed consent for participation after the nature of the study has been explained
•2\. Male or Female, aged six years (\+ zero days) to 12 years (\+ 364 days) on the day of enrolment
•3\. In good health as determined by:
•3\.1\. medical history
•3\.2\. pre\-vaccination check performed by a physician if indicated by history
•3\.3\. clinical judgment of the investigator
•4\. Able (in the investigators opinion) and willing to comply with all study requirements including being available for all the visits scheduled in the study
•5\. Parent or legally authorised representative is willing to allow his or her child?s (the participant?s) General Practitioner to be notified of participation in the study and contacted if required for confirmation of vaccination history
•6\. Whose parent or legally authorised representative believes to their best knowledge that their child has received all the recommended vaccinations as part of the UK routine childhood immunisation schedule (including Haemophilus influenzae B (Hib) if aged six months to four years in April 2003 (received 4/2003 \- 12/2004\) and Meningococcal C (MenC) if aged six months to 18 years in Nov 1999 (received 11/1999 \- 06/2001\) as part of the UK ?catch up? vaccination campaigns)

Exclusion Criteria

•1\. Have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component
•2\. Axillary temperature more than or equal to 38\.0°C or presence of any systemic illness on the day of enrolment
•3\. Have experienced significant acute or chronic infection within the previous seven days or have experienced fever (more than or equal to 38\.0°C) within the previous three days
•4\. Receipt of systemic antibiotics (either oral or parenteral) will delay enrolment until at least 14 days after cessation of antibiotics, with the exception of beta\-lactam antibiotics (examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.) who may be enrolled seven days after the last dose
•5\. Have a previous clinical or bacteriological or suspected diagnosis of meningitis
•6\. Have a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitis or Hib disease in the previous 60 days
•7\. Have a present or suspected serious disease such as metabolic, cardiac, autoimmune, endocrine (including insulin dependent diabetes), significant hepatic or renal impairment or progressive neurological impairment
•8\. Have any immunodeficiency, including use of systemic corticosteroids for more than five days or in a daily dose more than 1 mg/kg/day prednisone or equivalent for less than or equal to five days in the previous 30 days (inhaled high\-potency corticosteroids equivalent to budesonide 800 mcg/day or fluticasone 750 mcg/day)
•9\. Have a genetic anomaly e.g. Down?s syndrome
•10\. Born after a gestation period of less than 36 weeks or more than 42 weeks