Active immunisation of children for the prevention of invasive diseases caused by Neisseria meningitidis serogroup C MedDRA version: 12.1 Level: LLT Classification code 10028911 Term: Neisseria meningitidis infection NOS
Conditions
Interventions
Trade Name: Menjugate Kit
Pharmaceutical Form: Powder and solvent for suspension for injection
Other descriptive name: Neisseria meningitidis group C (strain C11) oligosaccharide Conjugated to Coryneb
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participant whose parent is willing and able to give informed consent for participation in the study. • Participant who gives assent for participation in the study. • Male or Female, aged 11 to 13 years. • Known to be free from medical problems as determined by a medical history and clinical assessment • Participated in the University of Oxford clinical trial: U01-Td5I-303/ C01.183 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • History of invasive meningococcal C disease • Any vaccination against MenC disease with the exception of a single dose in 2000 during the nationwide MenC immunisation campaign • Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection. • Major congenital defects or serious chronic illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Percentage of participants with rSBA titres >1:8 (correlate of protection).;Main Objective: The primary objective of this study is to calculate the percentage of 11 to 13 year old children whose meningococcal serogroup C (MenC) specific serum bactericidal assay using baby rabbit complement (rSBA) antibody titres are above the correlate of protection, from a cohort of children who received a single dose of a MenC conjugate vaccine at age 1-3 years;Secondary Objective: The secondary objectives of this study are to demonstrate sequential changes in MenC rSBA geometric mean titres (GMTs) from 1 to 10 years after receiving a dose of MenC vaccine in children who received a single dose of a MenC conjugate vaccine at age 1-3 years, and the percentage of children at each time point with MenC rSBA titres above the correlate of protection. An optional part of this study will also aim to extract DNA from the cellular plug remaining after serum centrifugation to contribute to a DNA bank to be used for genome wide analysis of the genetic factors influencing host response to the vaccines. | — |
Countries
United Kingdom
Outcome results
None listed