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Pertussis and Meningitis C Concomitant Vaccination in Adolescents (Mutliboost)

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ClinicalTrials.gov Identifier: NCT02526394
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Public Health England

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.

Condition or disease Intervention/treatment Phase
Pertussis Meningitis Preventive Immunization; Meningitis Immunization Biological: Meningococcal vaccine Drug: Pertussis containing vaccine Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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™)
Actual Study Start Date : September 2013
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Boostrix

Arm Intervention/treatment
Active Comparator: 1
Repevax + Meningitec
Biological: Meningococcal vaccine
Meningococcal vaccination
Other Name: Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix

Drug: Pertussis containing vaccine
Pertussis containing vaccination
Other Name: Boostrix, Repevax

Active Comparator: 2
Repevax + Neis-VacC
Biological: Meningococcal vaccine
Meningococcal vaccination
Other Name: Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix

Drug: Pertussis containing vaccine
Pertussis containing vaccination
Other Name: Boostrix, Repevax

Active Comparator: 3
Repevax + Menitorix
Biological: Meningococcal vaccine
Meningococcal vaccination
Other Name: Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix

Drug: Pertussis containing vaccine
Pertussis containing vaccination
Other Name: Boostrix, Repevax

Active Comparator: 4
Boostrix + Meningitec
Biological: Meningococcal vaccine
Meningococcal vaccination
Other Name: Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix

Drug: Pertussis containing vaccine
Pertussis containing vaccination
Other Name: Boostrix, Repevax

Active Comparator: 5
Boostrix + NeisVacC
Biological: Meningococcal vaccine
Meningococcal vaccination
Other Name: Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix

Drug: Pertussis containing vaccine
Pertussis containing vaccination
Other Name: Boostrix, Repevax

Active Comparator: 6
Boostrix + Menitorix
Biological: Meningococcal vaccine
Meningococcal vaccination
Other Name: Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix

Drug: Pertussis containing vaccine
Pertussis containing vaccination
Other Name: Boostrix, Repevax

Active Comparator: 7
Repevax + quadrivalent meningococcal conjugate )Nimenrix / Menveo)
Biological: Meningococcal vaccine
Meningococcal vaccination
Other Name: Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix

Drug: Pertussis containing vaccine
Pertussis containing vaccination
Other Name: Boostrix, Repevax

Active Comparator: 8
Boostrix + quadrivalent meningococcal conjugate )Nimenrix / Menveo)
Biological: Meningococcal vaccine
Meningococcal vaccination
Other Name: Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix

Drug: Pertussis containing vaccine
Pertussis containing vaccination
Other Name: Boostrix, Repevax




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Tetanus -specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL [ Time Frame: Day 28 following vaccination ]
    response to tetanus vaccination

  2. 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

  3. Diphtheria-specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL [ Time Frame: Day 28 following vaccination ]
    response to diphtheria vaccination



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526394


Locations
United Kingdom
Gloucestershire primary care
Gloucestershire, United Kingdom
Hertfordshire primary care
Hertfordshire, United Kingdom
Sponsors and Collaborators
Public Health England

Responsible Party: Public Health England
ClinicalTrials.gov Identifier: NCT02526394     History of Changes
Other Study ID Numbers: Multiboost
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Meningitis
Whooping Cough
Central Nervous System Diseases
Nervous System Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs