Comparison of Two Meningococcal ACWY Conjugate Vaccines (PRIME)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof. Elizabeth Miller, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT01192997
First received: August 31, 2010
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Meningococcal Meningitis
Biological: Menveo
Biological: MenACWY-TT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Health Protection Agency, United Kingdom:

Primary Outcome Measures:
  • Response to meningococcal components of the vaccines by serum bactericidal antibody [ Time Frame: December 2013 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 600
Study Start Date: June 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Menveo-Meningitec
Subjects who were primed with Meningitec who will receive Novartis Menveo
Biological: Menveo
Single dose Menveo (a MenACWY vaccine conjugated to CRM-197).
Active Comparator: MenACWY-TT-Meningitec
Subjects who were primed with Meningitec who will receive GSK MenACWY-TT
Biological: MenACWY-TT
Single dose MenACWY-TT (MenACWY vaccine conjugated to Tetanus Toxoid, TT)
Active Comparator: Menveo-Menjugate
Subjects who were primed with Menjugate who will receive Novartis Menveo
Biological: Menveo
Single dose Menveo (a MenACWY vaccine conjugated to CRM-197).
Active Comparator: MenACWY-TT-Menjugate
Subjects who were primed with Menjugate who will receive GSK MenACWY-TT vaccine.
Biological: MenACWY-TT
Single dose MenACWY-TT (MenACWY vaccine conjugated to Tetanus Toxoid, TT)
Active Comparator: Menveo-NeisVac-C
Subjects who were primed with NeisVac-C who will receive Novartis Menveo
Biological: Menveo
Single dose Menveo (a MenACWY vaccine conjugated to CRM-197).
Active Comparator: MenACWY-TT-NeisVac-C
Subjects who were primed with NeisVac-C who will receive GSK MenACWY-TT vaccine
Biological: MenACWY-TT
Single dose MenACWY-TT (MenACWY vaccine conjugated to Tetanus Toxoid, TT)

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Temporary Exclusion Criteria

• Receipt of systemic antibiotics (either oral or parenteral) will delay enrolment until at least 7 days after cessation of antibiotics.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192997

Locations
United Kingdom
Multiple General Practice surgeries
Gloucestershire, United Kingdom
Multiple General Practice surgeries
Hertfordshire, United Kingdom
Health Protection Agency, Immunisation Department, Colindale
London, United Kingdom, NW9 5EQ
Sponsors and Collaborators
Health Protection Agency, United Kingdom
Investigators
Study Chair: Elizabeth Miller, MD Health Protection Agency, United Kingdom
  More Information

No publications provided

Responsible Party: Prof. Elizabeth Miller, Consultant Epidemiologist, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier: NCT01192997     History of Changes
Other Study ID Numbers: PRIME
Study First Received: August 31, 2010
Last Updated: September 20, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Health Protection Agency, United Kingdom:
Meningitis
Meningococci
Meningitis C
Meningitis A
Meningitis W135
Meningitis Y
Antibody

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014