Persistence of antibodies six years after priming immunisation with Meningococcal C conjugate vaccine and response to the Hib-MenC (Menitorix®) vaccine in healthy childre
- Conditions
- Meningococcal C and Haemophilus influenzae type B diseasesInfections and Infestations
- Registration Number
- ISRCTN72858898
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 250
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)
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
11. Have scheduled elective surgery or other procedures requiring general anaesthesia during the study
12. Have received of any blood, blood products or parenteral immunoglobulin preparation within the past 12 weeks
13. Have received any additional doses of Hib or MenC vaccines in addition to those given in accordance with the UK routine immunisation schedule or ?catch up? campaigns
14. Participants who have participated in another research study involving an investigational product in the past 12 weeks or are planning to receive a vaccine or investigational product within the next month
15. Have a known bleeding diathesis or any condition associated with a prolonged bleeding time
16. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant?s ability to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum bactericidal antibody to meningococcal serogroup C six years after priming immunisation.
- Secondary Outcome Measures
Name Time Method 1. Measurement of antibody and B cell responses and assessment of memory induction following the Hib-MenC (Menitorix®) vaccine<br>2. Number and nature of any adverse events occuring during the study