Pertussis and Meningitis C Concomitant Vaccination in Adolescents

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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