Meningococcus group B disease, which can cause a variety of symptoms. The most serious of these are meningitis, and septicaemia (also known as blood poisoning).
Conditions
Interventions
Trade Name: Bexsero
Product Name: Bexsero
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Recombinant Neisseria meningitidis group B NHBA fusion protein
Concen
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For recruitment to all study groups: • Parents/legal guardians are willing and able to comply with the requirements of the trial protocol and have internet access for the duration of the study. • Parents/legal guardians have given informed consent for their child’s participation in the study • Participant is willing and able to give informed assent for participation in the trial. • In the Investigator’s opinion, participants are able and willing to comply with all trial requirements. • Parents/legal guardians/participants are willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial. For recruitment to study groups 1 to 6 only • Male or Female, aged approximately 11 years who have completed a vaccination course of meningitis B vaccine as an infant or toddler in a previous clinical trial conducted by OVG. For recruitment to Naïve groups 7 and 8 only • Male or Female, born between 25/06/2006 - 17/12/2006 who have not previously received meningitis vaccine Are the trial subjects under 18? yes Number of subjects for this age range: 0 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 trial if ANY of the following apply: • Children of parents/legal guardians who are on the delegation log for this study • History of invasive meningococcal B disease • History of being a household contact with a case of confirmed bacterial meningitis • Confirmed or suspected immunodeficiency • A family history of congenital or hereditary immunodeficiency, or maternal HIV • Current receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone >0.5ml/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed. • History of anaphylactic reaction to any component of the vaccine • No internet access for the duration of the study. • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. • Participants who have participated in another research trial involving an investigational product in the past 12 weeks. • Prior or planned receipt of any other investigational vaccine or drug. • Thrombocytopenia or any bleeding disorder. • Receipt of blood, blood products, or plasma derivatives within the past 3 months Exclusion to study groups 1 to 6 only • Any previous vaccination with 4CMenB vaccine except as part of V72P6, V72P6E1, V72P9 or V72P9E1 clinical trials. • Any previous vaccination with another meningococcal B vaccine (such as outer membrane vesicle vaccines) • Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 1 month or long-term systemic corticosteroid therapy (e.g. oral prednisolone >0.5ml/kg/day or intravenous glucocorticoid steroid). However, this may be discussed on a case-by-case basis. Nasal, topical or inhaled steroids are allowed. Exclusion to Naïve groups 7 and 8 only • Previous vaccination with 4CMenB vaccine or with any other meningococcal B vaccine (such as outer membrane vesicle vaccines) • Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy. • Current receipt of long-term systemic corticosteroid therapy (e.g. oral prednisolone >0.5ml/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed. • Long term prophylactic antibiotic use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if giving one booster dose of a licensed vaccine (4CMenB) to protect against meningococcal group B disease produces an antibody response that is protective in teenagers who were immunised as infants, as opposed to the two doses that are required for adolescents who have never been vaccinated before. ;Secondary Objective: To investigate the persistence of the protective antibody response in adolescents who were vaccinated against meningococcal group B disease as infants, and those who were vaccinated as an infant with a toddler booster vaccine. We will also explore: -the quantity and qualities of the responses to the vaccine including if the immune system keeps a memory of having encountered the vaccine, in adolescents after infant vaccination, after infant vaccination with toddler boosting, and after adolescent vaccination. - the impact of the vaccine on fever and other possible vaccine side effects in adolescents - if a giving a booster dose of the vaccine is more likely to result in expected vaccine side effects;Primary end point(s): Serum bactericidal activity against group B meningococcal strains before and after the immunsation, which is a measure of immunity to the pathogen.;Timepoint(s) of evaluation of this end point: Day 0, day 28 and 180 and 365 days post-treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To investigate the persistence of the protective antibody response in adolescents who were vaccinated against meningococcal group B disease as infants, and those who were vaccinated as an infant with a toddler booster vaccine. We will also explore: -the quantity and qualities of the responses to the vaccine including if the immune system keeps a memory of having encountered the vaccine, in adolescents after infant vaccination, after infant vaccination with toddler boosting, and after adolescent vaccination. - the impact of the vaccine on fever and other possible vaccine side effects in adolescents - if a giving a booster dose of the vaccine is more likely to result in expected vaccine side effects;Timepoint(s) of evaluation of this end point: Day 0, 28, 180 and 365 post treatment. | — |
Countries
United Kingdom
Contacts
Public ContactPollard
University of Oxford
Outcome results
None listed