Prevention of meningitis C and pertussis MedDRA version: 14.1 Level: LLT Classification code 10006021 Term: Booster System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10028910 Term: Neisseria meningitides meningitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10069577 Term: Pertussis immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDR
Conditions
Interventions
Trade Name: NeisvacC
Product Name: Neisvac-C
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Neisseria meningitidis group C (strain C11) polysaccharide (deOace
Sponsors
Public Health England
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The two principal objectives are: 1. IMMUNE RESPONSES TO MENINGITIS C AND WHOOPING COUGH: To estimate and compare the specific immune responses to concurrently administered booster vaccines against meningitis C and whooping cough in healthy adolescents. Participants will be adolescents aged 14 to 17 years, who have completed the UK childhood schedule of meningitis C and whooping cough vaccines appropriate for their age. Each participant in the trial will receive two vaccines given concomitantly: (a) a single dose of ONE of Meningitec™, Menjugate™, NeisVac-C™ , or Menitorix™ (meningitis C vaccines). (b) EITHER Repevax or IPV-Boostrix (whooping cough containing vaccines). Thus there will be eight different combinations of meningitis C and whooping cough-containing vaccines (and accordingly, eight arms/groups of study participants) Blood levels of specific antibodies against meningitis C and whooping cough will be measured in each participant. The measurements will be taken;Secondary Objective: To further enhance understanding of the immune responses to the study vaccines, additional outcomes (which are not specific to meningitis C or whooping cough, but are related to other components of the vaccines) will also be measured. These will help to clarify any potential inter-relationships amongst the various immune responses in the study context of concomitant vaccine administration. Depending on the particular components of each vaccine, the additional antibody levels that will be measured are to: - tetanus - diphtheria - Hib;Primary end point(s): FOR IMMUNE RESPONSES: - Proportions of participants with MENINGOCOCCAL serogroup C-specific rSBA titres =8 and =128 at baseline (before vaccination - Day 0), and 28 days after vaccination (Day 28). - Proportions of participants with =4-fold increase in geometric mean titres (GMTs) of rSBA on Day 28, compared to baseline. - Proportions of participants with PERTUSSIS antigen-specific antibodies (geometric m | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tetanus and Diphtheria-specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL Hib PRP-specific IgG GMCs and proportions achieving IgG concentrations of =0.15 or =1.00 µg/ml;Timepoint(s) of evaluation of this end point: Two timepoints i.e. Baseline (before vaccination - Day 0); and 28 days after vaccination (Day 28). Two timepoints - at baseline (prior to vaccination), and at 4-6 weeks later. | — |
Countries
United Kingdom
Contacts
Public ContactDr Jo Southern
Public Health England
Outcome results
None listed