Clinical trial NCT02526394: Pertussis and Meningitis C Concomitant Vaccination in Adolescents
Official title: A Phase III/IV Randomised Open-label Study and Comparison of the Immunogenicity and Safety of a Single Adolescent Booster Dose of a Meningococcal Group C Conjugate-containing Booster Vaccine (Meningitec™, OR NeisVac-C™ , OR Menitorix™), When Given Concurrently With an Acellular Pertussis-containing Booster Vaccine (Repevax™ or IPV-Boostrix™)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pertussis
Meningitis
Preventive Immunization; Meningitis
Immunization
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
First posted: 2015-08-18
Enrollment: 400
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 Exclusion Criteria

* Fever (sublingual temperature ≥ 38°C)
* Received systemic antibiotic(s) (either oral or parenteral) within the past 7 days. For all visits, if allowed by the study visit window, receipt of systemic antibiotics (either oral or parenteral) will delay venepuncture until at least 7 days after cessation of antibiotics.
* Received any blood or blood products within the past 12 weeks.
* Received another investigational agent within 90 days - or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial to the end of this study.
* Possibility of pregnancy

Primary outcomes:
measure: 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).
timeFrame: Day 28 following vaccination
measure: 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
timeFrame: Day 28 following vaccination
Secondary outcomes:
measure: Tetanus -specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL
timeFrame: Day 28 following vaccination
measure: Heamophilus type b (Hib)-polyribosylribitol phosphate(PRP)-specific IgG GMCs and proportions achieving IgG concentrations of ≥0.15 or ≥1.00 μg/ml
timeFrame: Day 28 following vaccination
measure: Diphtheria-specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL
timeFrame: Day 28 following vaccination
Other outcomes:
Locations:
city: Gloucestershire
country: United Kingdom
facility: Gloucestershire primary care
city: Hertfordshire
country: United Kingdom
facility: Hertfordshire primary care
Study officials:
References: