Understanding Immunity Persistence After Adolescent MenC Vaccination

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

University of Oxford

ClinicalTrials.gov Identifier:

NCT01459432

First received: October 21, 2011

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 21, 2011
Last Updated Date	January 28, 2013
Start Date ^ICMJE	November 2011
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 24, 2011)	Percentage of participants with rSBA titre ≥1:8 (correlate of protection). [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01459432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 24, 2011)	Geometric mean titre (GMT) rSBA. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Understanding Immunity Persistence After Adolescent MenC Vaccination
Official Title ^ICMJE	A Study to Evaluate the Persistence of Antibody Seven Years After a Booster Dose of Either a Glycoconjugate or a Polysaccharide Vaccine Against Serogroup C Neisseria Meningitidis Given to Adolescents
Brief Summary	The main purpose of this study is to evaluate the duration of immunity after a booster dose of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does seroprotection persist beyond teenage years and into the early twenties? This is the age group which is most likely to carry the organism and to transmit it to other members of the population. If a booster dose of MenC vaccine given to adolescents does produce protective levels of antibody which persist into early adulthood, this would strengthen the case for such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a resurgence of the disease in the future.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Young adults, approximately 20 - 23 years old.
Condition ^ICMJE	Antibody Persistance After Booster Dose of Men C Vaccine
Intervention ^ICMJE	Other: Venepuncture and blood sample collection. Venepuncture and blood sample collection.
Study Group/Cohort (s)	Follow-on blood sample from previous study Intervention: Other: Venepuncture and blood sample collection.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	260
Estimated Completion Date	March 2013
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Participants who completed clinical study M14P2E1 Participant who are willing to participate and who would be expected to comply with the requirements of the protocol Participants who have given informed consent for participation in the study Exclusion Criteria: History of invasive meningococcal C disease (or any case of invasive meningococcal disease where the serotype was unknown) Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection Severe blood clotting disorders
Gender	Both
Ages	20 Years to 23 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01459432
Other Study ID Numbers ^ICMJE	OVG 2011/03
Has Data Monitoring Committee	Not Provided
Responsible Party	University of Oxford
Study Sponsor ^ICMJE	University of Oxford
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Oxford
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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