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

October 21, 2011
January 28, 2013
November 2011
April 2012   (final data collection date for primary outcome measure)
Percentage of participants with rSBA titre ≥1:8 (correlate of protection). [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01459432 on ClinicalTrials.gov Archive Site
Geometric mean titre (GMT) rSBA. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
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Understanding Immunity Persistence After Adolescent MenC Vaccination
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Young adults, approximately 20 - 23 years old.

Antibody Persistance After Booster Dose of Men C Vaccine
Other: Venepuncture and blood sample collection.
Venepuncture and blood sample collection.
Follow-on blood sample from previous study
Intervention: Other: Venepuncture and blood sample collection.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
260
March 2013
April 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 23 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01459432
OVG 2011/03
Not Provided
University of Oxford
University of Oxford
Not Provided
Not Provided
University of Oxford
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP