Condition category
Infections and Infestations
Date applied
06/07/2006
Date assigned
04/09/2006
Last edited
28/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.paediatrics.ox.ac.uk/ovg/

Contact information

Type

Scientific

Primary contact

Dr Andrew Pollard

ORCID ID

Contact details

Centre for Vaccinology and Tropical Medicine
Churchill Hospital
Oxford
OX3 7LJ
United Kingdom

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 measures

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

Eligibility

Participant 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)

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. 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

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

http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20459323

Publication citations

  1. 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.

Additional files

Editorial Notes