Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OVG 2006/2
Study information
Scientific title
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
Acronym
Study hypothesis
To asess the persistence of antibodies, six years after priming immunisation with Meningococcal C conjugate vaccine and response to the Hib-MenC (Menitorix®) vaccine.
Please note that the following amendments have been made to this trial record as of 16/03/2009:
1. The public title has been changed from "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" to "Persistence of antibodies six years after priming immunisation with Meningococcal C conjugate vaccine and response to the Hib-MenC (Menitorix®) vaccine in healthy children". The original public title has been moved to the scientific title field.
2. The sponsor name has been amended from John Radcliffe Hospital (UK) to University of Oxford (UK) (due to incorrect sponsor name provided at time of registration).
Ethics approval
Favourable opinion granted from Oxfordshire LREC B on 13 July 2006.
Study design
Phase IV single-centre open-label trial
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Meningococcal C and Haemophilus influenzae type B diseases
Intervention
All 250 participants will receive one dose of the Hib-MenC (Menitorix®) conjugate vaccine. Blood samples will be taken at zero, one and 12 months after the vaccine. In 75 participants only, blood will also be taken on day seven.
Intervention type
Drug
Phase
Phase IV
Drug names
Menitorix®; (Haemophilus influenzae B [Hib] and Meningococcal C[MenC]) vaccine
Primary outcome measure
Serum bactericidal antibody to meningococcal serogroup C six years after priming immunisation.
Secondary outcome measures
1. Measurement of antibody and B cell responses and assessment of memory induction following the Hib-MenC (Menitorix®) vaccine
2. Number and nature of any adverse events occuring during the study
Overall trial start date
14/08/2006
Overall trial end date
16/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participants 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 childs (the participants) 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)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
250
Participant 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. Downs 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 participants ability to participate in the study
Recruitment start date
14/08/2006
Recruitment end date
16/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Vaccinology and Tropical Medicine
Oxford
OX3 7LJ
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
c/o Ms Heather House
Clinical Trials Office
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
GSK Biologicals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20459323
Publication citations
-
Results
Perrett KP, Winter AP, Kibwana E, Jin C, John TM, Yu LM, Borrow R, Curtis N, Pollard AJ, Antibody persistence after serogroup C meningococcal conjugate immunization of United Kingdom primary-school children in 1999-2000 and response to a booster: a phase 4 clinical trial., Clin. Infect. Dis., 2010, 50, 12, 1601-1610, doi: 10.1086/652765.