Immunization, Meningitis, Pertussis, Preventive Immunization; Meningitis
Conditions
Brief summary
The trial includes groups receiving various combinations of meningitis C and pertussis containing vaccines, to be administered concomitantly in adolescents due their school leaving booster vaccinations (as per UK routine immunisation schedule at 13-17 years of age). Immunogenicity and reactogenicity will be assessed.
Detailed description
Recent numbers of cases of infection with meningococcal C and pertussis (whooping cough), and the characteristics of the people who are these cases, makes it clear that UK adolescents will require booster doses of vaccination for both in the near future. These are increasingly important priorities for the national immunisation policy advisers to the Department of Health, the Joint Committee on Vaccination and Immunisation (JCVI). There are good indications that the likely target agegroup for these booster vaccinations will be at 14-17 years. Therefore this study seeks primarily to measure antibody responses to the meningitis C and whooping cough vaccines when given at the same time in this agegroup, and see how well the vaccines are tolerated. Up to 800 adolescents will be recruited across eight study groups. The eight groups arise as a result of combinations of four meningococcal and two whooping cough vaccines each participant will receive a single dose of each of the two types of vaccine (i.e. two injections). Two blood samples will be collected of 10ml each, one prior to vaccination and the second at 35 weeks later. These samples will allow assessment of how the immune system responds to the vaccinations in terms of the antibodies that are present in the blood. The study will also be assessing how well the vaccines are tolerated in this age group when given together, as described above. Each participant will therefor be asked to complete a health diary for the week following vaccination. This will record any redness/ swelling/ pain at the injection site as well as any illnesses or visits to a GP or hospital.
Interventions
BIOLOGICALMeningococcal vaccine
Meningococcal vaccination
Pertussis containing vaccination
Sponsors
Public Health England
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant is willing and able to give written informed consent for participation. If aged below 16 years, parent/legal guardian gives consent while the participant gives written assent for participation in the study. * Male or female aged 13 years and 6 months (+0 day) to 17 years (+364 days) on the day of consent. * Completed childhood meningococcal serogroup C and pertussis vaccination according to the UK (catch-up and/or routine) schedule appropriate for the participant's age
Exclusion criteria
\- The participant may not enter the study if ANY of the following apply: * Any contraindication to vaccination as specified in the Green Book- Immunisation against Infectious Disease. * Significant illness including progressive neurological disease or seizure disorder; confirmed or suspected immunosuppressive or immunodeficient conditions; major congenital defects; or known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time). * Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * History of invasive meningococcal disease or pertussis. * Significant contact (household or intimate exposure) to an individual with culture proven Neisseria meningitis disease or pertussis in the previous 60 days. * Received the routine teenage booster dose of tetanus/diphtheria/polio * Pregnancy Temporary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with serogroup C rabbit serum bactericidal assay (rSBA) titres ≥ 8 and ≥ 128 and rSBA geometric mean titre (GMTs) (and percentage with ≥ 4 fold rise compared to baseline). | Day 28 following vaccination | response to meningococcal vaccination |
| Pertussis antigen-specific antibody geometric mean concentration (GMCs) in IU/mL for pertussis toxin (PT), Pertactin, and filamentous haemaglutinnin (FHA) and in U/ml for fimbreal antigens (Fims) 2 and 3 | Day 28 following vaccination | response to pertussis vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tetanus -specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL | Day 28 following vaccination | response to tetanus vaccination |
| Heamophilus type b (Hib)-polyribosylribitol phosphate(PRP)-specific IgG GMCs and proportions achieving IgG concentrations of ≥0.15 or ≥1.00 μg/ml | Day 28 following vaccination | response to Hib vaccination |
| Diphtheria-specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL | Day 28 following vaccination | response to diphtheria vaccination |
Countries
United Kingdom
Outcome results
None listed