Multiboost - a trial of concurrent meningitis C and pertussis booster vaccines in adolescents

Phase 1

• Conditions: Prevention of meningitis C and pertussis; MedDRA version: 14.1Level: LLTClassification code 10006021Term: BoosterSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10028910Term: Neisseria meningitides meningitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10069593Term: Pertussis immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.0Level: LLTClassification code 10027275Term: Meningococcal infection, unspecifiedSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10034738Term: PertussisSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2012-005273-31-GB
• Lead Sponsor: Public Health England

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-02
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

• Participant is willing and able to give written informed consent for participation. If aged below 16 years, parent/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 MCC and pertussis vaccination according to the UK (catch-up and/or routine) schedule appropriate for the participant’s age
Are the trial subjects under 18? yes
Number of subjects for this age range: 640
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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, HMSO.
• 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 Td/IPV
• 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: All female potential participants will be assessed for the possibility of being pregnant. Assessment will be in accordance with PHE SOP CTSOP071 (Pregnancy Testing and Exclusion from Studies). If there is a possibility of being pregnant, the potential participant will be advised to consult their own GP for a pregnancy test. They will only be considered for recruitment if they choose to take a test and are confirmed as negative.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified