A Phase II/III Open Label, Randomised Study of the Safety, Reactogenicity and Immunogenicity of a Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine (Menveo) or Glaxosmithkline Meningococcal ACWY Conjugate Vaccine in Adolescents Who Were Primed with Meningitec, Menjugate or Neisvac-C During Preschool Vaccination - PRIME
- Conditions
- These vaccines are intended for the prevention of infection by meningococcal serogroups A,C,W135 and Y.
- Registration Number
- EUCTR2010-022505-18-GB
- Lead Sponsor
- Health Protection Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 93
6.4.1 Inclusion Criteria • Previously enrolled on the Preschool Men C study conducted by NVEC in 1999/2000 • Participant (or if under 16 years of age, participant's parent or legally authorized representative) is willing and able to give written informed consent for own or child's participation after the nature of the study has been explained. • No contraindications to vaccination as specified in the Green Book”- Immunisation against Infectious Disease, HMSO. • Participant (if under 16 years of age) who gives informed written assent for participation in the study. • Vaccinated with Meningitec (MCC CRM) or Menjugate (MCC CRM) or NeisVac-C (MCC TT) between 3.5-6 years of age. • Known to be free of relevant medical problems as determined by a medical history and clinical assessment. • Where applicable, parent or legally authorised representative is willing to allow his or her child’s GP to be notified of participation in the study and contacted if required for confirmation of vaccination history.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
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
The participant may not enter the study if ANY of the following apply: • History of invasive meningococcal disease. • Have a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitis disease in the previous 60 days. • Any vaccination against MenC disease since MCC vaccine given between 3.5 to 6 years. • Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection. • Major congenital defects or serious chronic disease including progressive neurological disease or seizure disorder. • Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. • Have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component. • Have 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 through the end of the study. • In the event that administration of another licensed vaccine is needed during the study, this vaccine should not be administered within 30 days of any study injection according to investigator’s judgment (exception: licensed flu-vaccine should not be administered within 14 days of study vaccines). • Have received any blood or blood products within the past 12 weeks. • Have any other significant disease or disorder 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. • Receipt of systemic antibiotics (either oral or parenteral) will delay enrolment until at least 7 days after cessation of antibiotics. The investigator can withdraw a subject from treatment if, in his or her clinical judgment, it is in the best interest of the subject. • Vaccination will be postponed until resolution of fever if axillary temperature is = 38 C. • For all visits, if allowed by the study visit window, receipt of systemic antibiotics (either oral or parental) will delay venepuncture until at least 7 days after cessation of antibiotics. • Female participants will be assessed for the need to perform a pregnancy test as per SOP CTSOP071 (Pregnancy Testing and Exclusion from Studies). If there is a possibility of being pregnant, a pregnancy test will be offered - in that case, participants who take up the test and are negative will be recruited.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To estimate and compare the serogroup A, C, Y and W135-specific immune response to two MenACWY conjugate vaccine formulations in participants who were vaccinated with either a single dose of Meningitec, Menjugate or NeisVac-C conjugate vaccine (MCC) during pre-school vaccination.;Secondary Objective: To explore the safety and tolerability of Novartis MenACWY or GSK MenACWY conjugate vaccine in healthy participants who were previously vaccinated with a single dose of MCC vaccine at pre-school vaccination.;Primary end point(s): To determine the proportion of subjects with adequate protection against the meningococcal strains in the vaccine after six or nine months.
- Secondary Outcome Measures
Name Time Method