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OpenTrials
Completed

NCT Number: NCT01459432

Understanding Immunity Persistence After Adolescent MenC Vaccination

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.

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Key information

Conditions

Antibody Persistance After Booster Dose of Men C Vaccine

Age range

20 year–23 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oxford Vaccine Group

Oxford, OX3 8NQ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venepuncture and blood sample collection.

Other

Venepuncture and blood sample collection.

Primary outcomes

  1. Percentage of participants with rSBA titre ≥1:8 (correlate of protection).

    Time frame: 4 months

Secondary outcomes

  1. Geometric mean titre (GMT) rSBA.

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
First posted
Oct 25, 2011
Registry last updated
Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.