Understanding Immunity Persistence After Adolescent MenC Vaccination

Completed

• Conditions: Antibody Persistance After Booster Dose of Men C Vaccine

• Registration Number: NCT01459432
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Study Start: 2011-11
• Primary Completion: 2012-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-06
• Last Update Posted: 2015-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants with rSBA titre ≥1:8 (correlate of protection).	4 months

Secondary Outcome Measures

Name	Time	Method
Geometric mean titre (GMT) rSBA.	4 months

Trial Locations

Locations (1)

Oxford Vaccine Group; 🇬🇧 Oxford, United Kingdom