Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Jo Southern


Contact details

Centre for Infections
Health Protection Agency
61 Colindale Avenue
United Kingdom

Additional identifiers

EudraCT number

2012-005273-31 number

Protocol/serial number


Study information

Scientific 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 Menjugate™, or NeisVac-C™, or Menitorix™), when given concurrently with an acellular pertussis-containing booster vaccine (Repevax™ or IPV-Boostrix™)


Study hypothesis

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 age group, we will also see how well the vaccines are tolerated.

We will recruit up to 800 adolescents 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). We will collect two blood samples of 10ml each, one prior to vaccination and the second at 35 weeks later. These samples will allow us to assess how the immune system responds to the vaccinations in terms of the antibodies that are present in the blood.

We will also be assessing how well the vaccines are tolerated in this age group when given together, as described above. We will therefore ask each participant to complete a health diary for the week following vaccination. They will be asked to record any redness/ swelling/ pain at the injection site as well as any illnesses or visits to their GP or hospital.

More details can be found at:

Ethics approval


Study design

Randomised interventional trial; Design type: Prevention, Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet


Topic: Medicines for Children Research Network, Primary Care Research Network for England; Subtopic: All Diagnoses, Not Assigned; Disease: All Diseases


Boostriv-IPV, Combination dTaP3/IPV vaccine
Meningitec, Meningococcal serogroup C conjugate vaccine
Menitorix, Combined meningococcal serogroup C and Hib conjugate vaccine
Menjugate, Meningococcal serogroup C conjugate vaccine
NeisVac-C, Meningococcal serogroup C conjugate vaccine
Repevax, Combined dTaP5/IPV vaccine

Follow Up Length: 1 month

Study Entry : Single Randomisation only

Intervention type



Phase IV

Drug names

Meningitec,Menitorix, Menjugate,NeisVac-C, Repevax, Boostriv-IPV

Primary outcome measures

Primary immunological objective; Timepoint(s): To estimate and compare the meningococcal serogroup C-specific and pertussis-specific immune response

Secondary outcome measures

1. Primary safety objective; To explore the safety and tolerability of each study combination of MCC and pertussis-containing vaccine
2. Secondary immunological objective; To estimate and compare the tetanus, diphtheria, and (in appropriate study arms) Hib immune response

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. 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.
•2. Male or female aged 14 years (+0 day) to 17 years (+364 days) on the day of consent.
•3. Completed MCC and pertussis vaccination according to the UK (catch-up and/or routine) schedule appropriate for the participant’s age

Participant type


Age group




Target number of participants

Planned Sample Size: 880; UK Sample Size: 880; Description: 110 participants per group, over 8 groups = 880 total. To account for attrition we will use a +/10% tolerance around these figures

Participant exclusion criteria

Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
•1. Any contraindication to vaccination as specified in the “Green Book”- Immunisation against Infectious Disease, HMSO.
•2. 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).
•3. 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.
4. History of invasive meningococcal disease or pertussis.
5. Significant contact (household or intimate exposure) to an individual with culture proven Neisseria meningitis disease or pertussis in the previous 60 days.
6. Any MCC or pertussis vaccination that is not according to the UK (catch-up or routine) schedule appropriate for the participant’s age.
7. Pregnancy

Temporary Exclusion Criteria
1. Fever (sublingual temperature >= 38°C)
2. 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.
3. Received any blood or blood products within the past 12 weeks.
4. 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.
5. Possibility of pregnancy: All female potential participants will be assessed for the possibility of being pregnant. Assessment will be in accordance with SOP CTSOP071 (Pregnancy Testing and Exclusion from Studies). If there is a possibility of being pregnant, they will be advised to consult their own GP for a pregnancy test. They can only be considered for recruitment if they choose to take a test and are negative.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Centre for Infections
United Kingdom

Sponsor information


Health Protection Agency (HPA)

Sponsor details

Centre for Infections
61 Colindale Avenue
United Kingdom

Sponsor type




Funder type


Funder name

Department of Health - Policy Research Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes