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There is evidence of waning immunity in individuals vaccinated against meningitis C as part of the UK infant immunisation schedule. The intention of this study is to contact participants of a previous NVEC (National Vaccine Evalutaion Consortium) clinical trial (a PreSchool Men C trial, in which participants were randomised to receive Meningitec, Menjugate or Neisvac-C). They will be invited to enrol and will be randomised to receive one of two quadrivalent meningococcal ACWY vaccines, to look at the boosting effect they may confer.
Between 550 and 650 subjects enrolled in a previous Meningococcal C vaccine study will be invited to join this new study looking at the boosting effects of two quadrivalent meningococcal ACWY vaccines. If they choose to participate, they will be randomised to receive one of the ACWY vaccines. Within each vaccine group, there will be further division into short (6 months) or longer (9 months) follow-up.
Each participant will be given one dose of an allocated vaccine. Blood samples will be taken three times from each participant - the first sample will be pre-vaccination; the second sample will be taken one month after vaccination; and the third and final sample at either six or nine months after vaccination (depending on the group they are randomised to).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menveo-Meningitec | Active Comparator | Subjects who were primed with Meningitec who will receive Novartis Menveo |
|
| MenACWY-TT-Meningitec | Active Comparator | Subjects who were primed with Meningitec who will receive GSK MenACWY-TT |
|
| Menveo-Menjugate | Active Comparator | Subjects who were primed with Menjugate who will receive Novartis Menveo |
|
| MenACWY-TT-Menjugate | Active Comparator | Subjects who were primed with Menjugate who will receive GSK MenACWY-TT vaccine. |
|
| Menveo-NeisVac-C | Active Comparator | Subjects who were primed with NeisVac-C who will receive Novartis Menveo |
|
| MenACWY-TT-NeisVac-C | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menveo | Biological | Single dose Menveo (a MenACWY vaccine conjugated to CRM-197). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response to meningococcal components of the vaccines by serum bactericidal antibody | Percentage of participants with serogroup-specific rabbit Serum Bactericidal Antibody (rSBA) titres ≥ 8 at one month post vaccination, for each of the serogroups A, C, W135 and Y. (This titre of rSBA is a documented correlate of protection for meningococcal conjugate vaccines) | December 2013 |
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Inclusion Criteria:
Exclusion Criteria:
Temporary Exclusion Criteria
• Receipt of systemic antibiotics (either oral or parenteral) will delay enrolment until at least 7 days after cessation of antibiotics.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Miller, MD | Public Health England | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple General Practice surgeries | Gloucester | Gloucestershire | United Kingdom | |||
| Multiple General Practice surgeries |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26075813 | Result | Ishola DA, Andrews N, Waight P, Yung CF, Southern J, Bai X, Findlow H, Matheson M, England A, Hallis B, Findlow J, Borrow R, Miller E. Randomized Trial to Compare the Immunogenicity and Safety of a CRM or TT Conjugated Quadrivalent Meningococcal Vaccine in Teenagers who Received a CRM or TT Conjugated Serogroup C Vaccine at Preschool Age. Pediatr Infect Dis J. 2015 Aug;34(8):865-74. doi: 10.1097/INF.0000000000000750. |
| Label | URL |
|---|---|
| Published study results | View source |
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| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| C576777 | tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Subjects who were primed with NeisVac-C who will receive GSK MenACWY-TT vaccine
|
| MenACWY-TT | Biological | Single dose MenACWY-TT (MenACWY vaccine conjugated to Tetanus Toxoid, TT) |
|
| Hertford |
| Hertfordshire |
| United Kingdom |
| Health Protection Agency, Immunisation Department, Colindale | London | NW9 5EQ | United Kingdom |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |