Understanding Immunity Persistence After Adolescent MenC Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01459432
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : November 9, 2015
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment
Antibody Persistance After Booster Dose of Men C Vaccine Other: Venepuncture and blood sample collection.

Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : November 2011
Actual Primary Completion Date : April 2012

Group/Cohort Intervention/treatment
Follow-on blood sample from previous study Other: Venepuncture and blood sample collection.
Venepuncture and blood sample collection.

Primary Outcome Measures :
  1. Percentage of participants with rSBA titre ≥1:8 (correlate of protection). [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Geometric mean titre (GMT) rSBA. [ Time Frame: 4 months ]

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Ages Eligible for Study:   20 Years to 23 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young adults, approximately 20 - 23 years old.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01459432

United Kingdom
Oxford Vaccine Group
Oxford, United Kingdom, OX3 8NQ
Sponsors and Collaborators
University of Oxford

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Oxford Identifier: NCT01459432     History of Changes
Other Study ID Numbers: OVG 2011/03
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: November 9, 2015
Last Verified: November 2015