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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Antibody Persistance After Booster Dose of Men C Vaccine
- Sponsor
- University of Oxford
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Percentage of participants with rSBA titre ≥1:8 (correlate of protection).
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Percentage of participants with rSBA titre ≥1:8 (correlate of protection).
Time Frame: 4 months
Secondary Outcomes
- Geometric mean titre (GMT) rSBA.(4 months)