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Pertussis and Meningitis C Concomitant Vaccination in Adolescents (Mutliboost)

Primary Purpose

Pertussis, Meningitis, Preventive Immunization; Meningitis

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Meningococcal vaccine

Pertussis containing vaccine

About this trial

This is an interventional treatment trial for Pertussis

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Gloucestershire primary care
Hertfordshire primary care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Arm Label

Arm Description

Repevax + Meningitec

Repevax + Neis-VacC

Repevax + Menitorix

Boostrix + Meningitec

Boostrix + NeisVacC

Boostrix + Menitorix

Repevax + quadrivalent meningococcal conjugate )Nimenrix / Menveo)

Boostrix + quadrivalent meningococcal conjugate )Nimenrix / Menveo)

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Tetanus -specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL

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

response to Hib vaccination

Diphtheria-specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL

response to diphtheria vaccination

Full Information

NCT ID

NCT02526394

First Posted

August 11, 2015

Last Updated

March 20, 2019

Sponsor

Public Health England

1. Study Identification

Unique Protocol Identification Number

NCT02526394

Brief Title

Pertussis and Meningitis C Concomitant Vaccination in Adolescents

Acronym

Mutliboost

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

September 2013 (Actual)

Primary Completion Date

March 31, 2017 (Actual)

Study Completion Date

March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Public Health England

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pertussis, Meningitis, Preventive Immunization; Meningitis, Immunization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Repevax + Meningitec

Arm Title

Arm Type

Active Comparator

Arm Description

Repevax + Neis-VacC

Arm Title

Arm Type

Active Comparator

Arm Description

Repevax + Menitorix

Arm Title

Arm Type

Active Comparator

Arm Description

Boostrix + Meningitec

Arm Title

Arm Type

Active Comparator

Arm Description

Boostrix + NeisVacC

Arm Title

Arm Type

Active Comparator

Arm Description

Boostrix + Menitorix

Arm Title

Arm Type

Active Comparator

Arm Description

Repevax + quadrivalent meningococcal conjugate )Nimenrix / Menveo)

Arm Title

Arm Type

Active Comparator

Arm Description

Boostrix + quadrivalent meningococcal conjugate )Nimenrix / Menveo)

Intervention Type

Biological

Intervention Name(s)

Meningococcal vaccine

Other Intervention Name(s)

Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix

Intervention Description

Meningococcal vaccination

Intervention Type

Drug

Intervention Name(s)

Pertussis containing vaccine

Other Intervention Name(s)

Boostrix, Repevax

Intervention Description

Pertussis containing vaccination

Primary Outcome Measure Information:

Title

Description

response to meningococcal vaccination

Time Frame

Day 28 following vaccination

Title

Description

response to pertussis vaccination

Time Frame

Day 28 following vaccination

Secondary Outcome Measure Information:

Title

Tetanus -specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL

Description

response to tetanus vaccination

Time Frame

Day 28 following vaccination

Title

Heamophilus type b (Hib)-polyribosylribitol phosphate(PRP)-specific IgG GMCs and proportions achieving IgG concentrations of ≥0.15 or ≥1.00 μg/ml

Description

response to Hib vaccination

Time Frame

Day 28 following vaccination

Title

Diphtheria-specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL

Description

response to diphtheria vaccination

Time Frame

Day 28 following vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Gloucestershire primary care

City

Gloucestershire

Country

United Kingdom

Facility Name

Hertfordshire primary care

City

Hertfordshire

Country

United Kingdom

12. IPD Sharing Statement

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Pertussis and Meningitis C Concomitant Vaccination in Adolescents

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