Comparison of Two Meningococcal ACWY Conjugate Vaccines
PRIME
A Phase 2/3, Open Label, Randomised Study of the Safety, Reactogenicity and Immunogenicity of a Single Dose of Novartis Meningococcal ACWY (Menveo) or GSK Meningococcal ACWY Conjugate Vaccine in Adolescents Primed With Meningitec, Menjugate or Neisvac-C in Preschool Vaccination
1 other identifier
interventional
91
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2012
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedOctober 1, 2020
August 1, 2018
1.3 years
August 31, 2010
September 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (6)
Menveo-Meningitec
ACTIVE COMPARATORSubjects who were primed with Meningitec who will receive Novartis Menveo
MenACWY-TT-Meningitec
ACTIVE COMPARATORSubjects who were primed with Meningitec who will receive GSK MenACWY-TT
Menveo-Menjugate
ACTIVE COMPARATORSubjects who were primed with Menjugate who will receive Novartis Menveo
MenACWY-TT-Menjugate
ACTIVE COMPARATORSubjects who were primed with Menjugate who will receive GSK MenACWY-TT vaccine.
Menveo-NeisVac-C
ACTIVE COMPARATORSubjects who were primed with NeisVac-C who will receive Novartis Menveo
MenACWY-TT-NeisVac-C
ACTIVE COMPARATORSubjects who were primed with NeisVac-C who will receive GSK MenACWY-TT vaccine
Interventions
Single dose Menveo (a MenACWY vaccine conjugated to CRM-197).
Single dose MenACWY-TT (MenACWY vaccine conjugated to Tetanus Toxoid, TT)
Eligibility Criteria
You may qualify if:
- Previously enrolled on the Preschool Men C study conducted by NVEC in 1999/2000
- Participant's parent or legally authorized representative is willing and able to give written informed consent for 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 who gives 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 medical problems as determined by a medical history and clinical assessment.
- 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.
You may not qualify if:
- 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.
- Participant is pregnant.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Multiple General Practice surgeries
Gloucester, Gloucestershire, United Kingdom
Multiple General Practice surgeries
Hertford, Hertfordshire, United Kingdom
Health Protection Agency, Immunisation Department, Colindale
London, NW9 5EQ, United Kingdom
Related Publications (1)
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.
PMID: 26075813RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Elizabeth Miller, MD
Public Health England
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2010
First Posted
September 1, 2010
Study Start
June 1, 2012
Primary Completion
October 1, 2013
Study Completion
March 1, 2014
Last Updated
October 1, 2020
Record last verified: 2018-08