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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Repevax + Meningitec |
|
| 2 | Active Comparator | Repevax + Neis-VacC |
|
| 3 | Active Comparator | Repevax + Menitorix |
|
| 4 | Active Comparator | Boostrix + Meningitec |
|
| 5 | Active Comparator | Boostrix + NeisVacC |
|
| 6 | Active Comparator | Boostrix + Menitorix |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal vaccine | Biological | Meningococcal vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | response to meningococcal vaccination | Day 28 following 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 | response to pertussis vaccination | Day 28 following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Tetanus -specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL | response to tetanus vaccination | Day 28 following vaccination |
| Heamophilus type b (Hib)-polyribosylribitol phosphate(PRP)-specific IgG GMCs and proportions achieving IgG concentrations of ≥0.15 or ≥1.00 μg/ml |
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Inclusion Criteria:
Exclusion Criteria:
-
The participant may not enter the study if ANY of the following apply:
Temporary Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gloucestershire primary care | Gloucestershire | Gloucestershire | United Kingdom | |||
| Hertfordshire primary care |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| C505143 | Boostrix |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| 7 | Active Comparator | Repevax + quadrivalent meningococcal conjugate )Nimenrix / Menveo) |
|
| 8 | Active Comparator | Boostrix + quadrivalent meningococcal conjugate )Nimenrix / Menveo) |
|
|
| Pertussis containing vaccine | Drug | Pertussis containing vaccination |
|
|
response to Hib vaccination |
| Day 28 following vaccination |
| Diphtheria-specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL | response to diphtheria vaccination | Day 28 following vaccination |
| Hertfordshire |
| Hertfordshire |
| United Kingdom |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |