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CompletedNCT01192997PRIMEUpdated Oct 1, 2020

Comparison of Two Meningococcal ACWY Conjugate Vaccines

A Phase 2/3 interventional study of Menveo and MenACWY-TT in Meningococcal Meningitis, sponsored by Public Health England. Completed at 3 sites in United Kingdom. Open to participants aged 14 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-01.

Sponsored by Public Health England · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
14 Years to 21 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Meningococcal Meningitis

Keywords

  • Meningitis
  • Meningococci
  • Meningitis C
  • Meningitis A
  • Meningitis W135
  • Meningitis Y
  • Antibody
03

In context

Meningitis, Meningococcal

125 studies on the registry are indexed under Meningitis, Meningococcal; 10 are open to participants now.

This study's enrollment of 91 is below the median of 538 across 113 interventional studies indexed under Meningitis, Meningococcal.

Browse Meningitis, Meningococcal studies →

Lead sponsor

Public Health England is the lead sponsor of 37 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for participation after the nature of the study has been explained.
  • No 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

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 or immunodeficient conditions, including (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 to any vaccine component.
  • Have received another 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
91 participants (actual)

Study arms

  • Active comparator
    Menveo-Meningitec

    Subjects who were primed with Meningitec who will receive Novartis Menveo

    Biological: Menveo

  • Active comparator
    MenACWY-TT-Meningitec

    Subjects who were primed with Meningitec who will receive GSK MenACWY-TT

    Biological: MenACWY-TT

  • Active comparator
    Menveo-Menjugate

    Subjects who were primed with Menjugate who will receive Novartis Menveo

    Biological: Menveo

  • Active comparator
    MenACWY-TT-Menjugate

    Subjects who were primed with Menjugate who will receive GSK MenACWY-TT vaccine.

    Biological: MenACWY-TT

  • Active comparator
    Menveo-NeisVac-C

    Subjects who were primed with NeisVac-C who will receive Novartis Menveo

    Biological: Menveo

  • Active comparator
    MenACWY-TT-NeisVac-C

    Subjects who were primed with NeisVac-C who will receive GSK MenACWY-TT vaccine

    Biological: MenACWY-TT

Interventions

  • BiologicalMenveo

    Single dose Menveo (a MenACWY vaccine conjugated to CRM-197).

  • BiologicalMenACWY-TT

    Single dose MenACWY-TT (MenACWY vaccine conjugated to Tetanus Toxoid, TT)

06

What researchers measure

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)

    Time frame: December 2013

07

Study locations

3 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 26075813 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2012, a primary completion of Oct 2013 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2010
First posted
Sep 1, 2010
Start
Jun 2012
Primary completionActual
Oct 2013
CompletionActual
Mar 2014
Last update
Oct 1, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01192997
Lead sponsor
Public Health England
Responsible party
Sponsor
First posted
Sep 1, 2010
Start date
Jun 2012
Primary completion
Oct 2013
Completion
Mar 2014
Last update
Oct 1, 2020

Study contacts

Elizabeth Miller, MD
study chair · Public Health England

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine

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Public Health England

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