Understanding Immunity Persistence After Adolescent MenC Vaccination

NCT ID: NCT01459432

Last Updated: 2015-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Brief Summary

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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

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Conditions

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Antibody Persistance After Booster Dose of Men C Vaccine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Follow-on blood sample from previous study

Venepuncture and blood sample collection.

Intervention Type OTHER

Venepuncture and blood sample collection.

Interventions

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Venepuncture and blood sample collection.

Venepuncture and blood sample collection.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oxford Vaccine Group

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

References

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de Whalley PC, Snape MD, Plested E, Thompson B, Nuthall E, Omar O, Borrow R, Pollard AJ. Long-term seroprotection after an adolescent booster meningococcal serogroup C vaccination. Arch Dis Child. 2013 Sep;98(9):686-91. doi: 10.1136/archdischild-2013-303893. Epub 2013 Jul 13.

Reference Type DERIVED
PMID: 23853000 (View on PubMed)

Other Identifiers

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OVG 2011/03

Identifier Type: -

Identifier Source: org_study_id

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