Brief Title
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™)
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.
Study Phase
Phase 4
Study Type
Interventional
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).
Secondary Outcome
Tetanus -specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL
Condition
Pertussis
Intervention
Meningococcal vaccine
Study Arms / Comparison Groups
1
Description: Repevax + Meningitec
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
400
Start Date
September 2013
Completion Date
March 31, 2017
Primary Completion Date
March 31, 2017
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
Gender
All
Ages
13 Years - 17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02526394
Organization ID
Multiboost
Responsible Party
Sponsor
Study Sponsor
Public Health England
Study Sponsor
, ,
Verification Date
April 2018