- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02526394
Pertussis and Meningitis C Concomitant Vaccination in Adolescents (Mutliboost)
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Gloucestershire, United Kingdom
- Gloucestershire Primary Care
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Hertfordshire, United Kingdom
- Hertfordshire primary care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
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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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Repevax + Meningitec
|
Meningococcal vaccination
Other Names:
Pertussis containing vaccination
Other Names:
|
Active Comparator: 2
Repevax + Neis-VacC
|
Meningococcal vaccination
Other Names:
Pertussis containing vaccination
Other Names:
|
Active Comparator: 3
Repevax + Menitorix
|
Meningococcal vaccination
Other Names:
Pertussis containing vaccination
Other Names:
|
Active Comparator: 4
Boostrix + Meningitec
|
Meningococcal vaccination
Other Names:
Pertussis containing vaccination
Other Names:
|
Active Comparator: 5
Boostrix + NeisVacC
|
Meningococcal vaccination
Other Names:
Pertussis containing vaccination
Other Names:
|
Active Comparator: 6
Boostrix + Menitorix
|
Meningococcal vaccination
Other Names:
Pertussis containing vaccination
Other Names:
|
Active Comparator: 7
Repevax + quadrivalent meningococcal conjugate )Nimenrix / Menveo)
|
Meningococcal vaccination
Other Names:
Pertussis containing vaccination
Other Names:
|
Active Comparator: 8
Boostrix + quadrivalent meningococcal conjugate )Nimenrix / Menveo)
|
Meningococcal vaccination
Other Names:
Pertussis containing vaccination
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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).
Time Frame: Day 28 following vaccination
|
response to meningococcal vaccination
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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
Time Frame: Day 28 following vaccination
|
response to pertussis vaccination
|
Day 28 following vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tetanus -specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL
Time Frame: Day 28 following vaccination
|
response to tetanus vaccination
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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
Time Frame: Day 28 following vaccination
|
response to Hib vaccination
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Day 28 following vaccination
|
Diphtheria-specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL
Time Frame: Day 28 following vaccination
|
response to diphtheria vaccination
|
Day 28 following vaccination
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Bordetella Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Whooping Cough
- Meningitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- Multiboost
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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