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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
  Purpose

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 Intervention
Antibody Persistance After Booster Dose of Men C Vaccine
 Other: Venepuncture and blood sample collection.

Study Type: Observational
Study Design: 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

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Percentage of participants with rSBA titre ≥1:8 (correlate of protection). [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geometric mean titre (GMT) rSBA. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: November 2011
Estimated Study Completion Date: March 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Follow-on blood sample from previous study Other: Venepuncture and blood sample collection.
Venepuncture and blood sample collection.

  Eligibility

Ages Eligible for Study:   20 Years to 23 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Young adults, approximately 20 - 23 years old.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459432

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

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01459432     History of Changes
Other Study ID Numbers: OVG 2011/03
Study First Received: October 21, 2011
Last Updated: January 28, 2013
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on May 23, 2013