PertussisPhase 4MutliboostNCT02526394
Pertussis and Meningitis C Concomitant Vaccination in Adolescents
A Phase 4 study testing Meningococcal vaccine and Pertussis containing vaccine in people with Pertussis and Meningitis, run by Public Health England at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis, Meningitis, Preventive Immunization; Meningitis
- What is being tested?
- Meningococcal vaccine and Pertussis containing vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2013to 31 Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- -
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Gloucestershire primary care
Gloucestershire, Gloucestershire
Hertfordshire primary care
Hertfordshire, Hertfordshire
About this study
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™)
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.
Read the 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.
- Being tested
- Meningococcal vaccine, Pertussis containing vaccine
- Medical subject headings
- Whooping Cough, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal vaccineBiological
Also called Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix
Meningococcal vaccination
Pertussis containing vaccineDrug
Also called Boostrix, Repevax
Pertussis containing vaccination
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Repevax + Meningitec Receives: Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine |
| 2 | Active comparator | Repevax + Neis-VacC Receives: Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine |
| 3 | Active comparator | Repevax + Menitorix Receives: Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine |
| 4 | Active comparator | Boostrix + Meningitec Receives: Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine |
| 5 | Active comparator | Boostrix + NeisVacC Receives: Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine |
| 6 | Active comparator | Boostrix + Menitorix Receives: Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine |
| 7 | Active comparator | Repevax + quadrivalent meningococcal conjugate )Nimenrix / Menveo) Receives: Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine |
| 8 | Active comparator | Boostrix + quadrivalent meningococcal conjugate )Nimenrix / Menveo) Receives: Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 28 following vaccination
Secondary outcomes (3)
Tetanus -specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL
response to tetanus vaccination
Measured: 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
response to Hib vaccination
Measured: Day 28 following vaccination
Diphtheria-specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL
response to diphtheria vaccination
Measured: Day 28 following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startSep 2013
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526394
- Sponsor's protocol ID
- Multiboost
- Acronym
- Mutliboost
- Status last verified
- Apr 2018
- First submitted
- 11 Aug 2015
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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™)
- ClinicalTrials.gov ID
- NCT02526394
- Acronym / sponsor ID
- Mutliboost / Multiboost
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Sep 2013 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Meningococcal vaccine, Drug: Pertussis containing vaccineRepevax + Meningitec |
| 2 | Active comparator | Biological: Meningococcal vaccine, Drug: Pertussis containing vaccineRepevax + Neis-VacC |
| 3 | Active comparator | Biological: Meningococcal vaccine, Drug: Pertussis containing vaccineRepevax + Menitorix |
| 4 | Active comparator | Biological: Meningococcal vaccine, Drug: Pertussis containing vaccineBoostrix + Meningitec |
| 5 | Active comparator | Biological: Meningococcal vaccine, Drug: Pertussis containing vaccineBoostrix + NeisVacC |
| 6 | Active comparator | Biological: Meningococcal vaccine, Drug: Pertussis containing vaccineBoostrix + Menitorix |
| 7 | Active comparator | Biological: Meningococcal vaccine, Drug: Pertussis containing vaccineRepevax + quadrivalent meningococcal conjugate )Nimenrix / Menveo) |
| 8 | Active comparator | Biological: Meningococcal vaccine, Drug: Pertussis containing vaccineBoostrix + quadrivalent meningococcal conjugate )Nimenrix / Menveo) |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- -
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meningococcal vaccineAlso: Meningitec, NeisVacC, Menitorix, Menveo, NimenrixMeningococcal vaccination | Biological | 1, 2, 3, 4, 5, 6, 7, 8 |
| Pertussis containing vaccineAlso: Boostrix, RepevaxPertussis containing vaccination | Drug | 1, 2, 3, 4, 5, 6, 7, 8 |
Primary outcome
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
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
3 secondary outcomes
Tetanus -specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL
Time frame: 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
Diphtheria-specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL
Time frame: Day 28 following vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meningococcal vaccine and Pertussis containing vaccine in people with Pertussis and Meningitis, run by Public Health England at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: Day 28 following vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.