Multiboost - MCC plus pertussis booster in adolescents
- Conditions
- Topic: Medicines for Children Research Network, Primary Care Research Network for EnglandSubtopic: All Diagnoses, Not AssignedDisease: All DiseasesInfections and InfestationsVaccinations
- Registration Number
- ISRCTN18766300
- Lead Sponsor
- Health Protection Agency (HPA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 388
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Meningococcal serogroup C-specific and pertussis-specific immune response
- Secondary Outcome Measures
Name Time Method <br> 1. Safety and tolerability of each study combination of MCC and pertussis-containing vaccine<br> 2. Tetanus, diphtheria, and (in appropriate study arms) Hib immune response<br>