Persistence of antibodies six years after priming immunisation with Meningococcal C conjugate vaccine and response to the Hib-MenC (Menitorix®) vaccine in healthy children
| ISRCTN | ISRCTN72858898 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72858898 |
| Secondary identifying numbers | OVG 2006/2 |
- Submission date
- 06/07/2006
- Registration date
- 04/09/2006
- Last edited
- 28/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew Pollard
Scientific
Scientific
Centre for Vaccinology and Tropical Medicine
Churchill Hospital
Oxford
OX3 7LJ
United Kingdom
Study information
| Study design | Phase IV single-centre open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 |
| Study objectives | 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(s) | Favourable opinion granted from Oxfordshire LREC B on 13 July 2006. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 14/08/2006 |
| Completion date | 16/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 250 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 14/08/2006 |
| Date of final enrolment | 16/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Vaccinology and Tropical Medicine
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Sponsor information
University of Oxford (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Ms Heather House
Clinical Trials Office
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom
| Website | http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Industry
GSK Biologicals (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/06/2010 | Yes | No |
