Comparison of Two Meningococcal ACWY Conjugate Vaccines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Meningococcal Meningitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Menveo-Meningitec

Subjects who were primed with Meningitec who will receive Novartis Menveo

Group Type ACTIVE_COMPARATOR

Menveo

Intervention Type BIOLOGICAL

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

MenACWY-TT-Meningitec

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

Group Type ACTIVE_COMPARATOR

MenACWY-TT

Intervention Type BIOLOGICAL

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

Menveo-Menjugate

Subjects who were primed with Menjugate who will receive Novartis Menveo

Group Type ACTIVE_COMPARATOR

Menveo

Intervention Type BIOLOGICAL

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

MenACWY-TT-Menjugate

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

Group Type ACTIVE_COMPARATOR

MenACWY-TT

Intervention Type BIOLOGICAL

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

Menveo-NeisVac-C

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

Group Type ACTIVE_COMPARATOR

Menveo

Intervention Type BIOLOGICAL

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

MenACWY-TT-NeisVac-C

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

Group Type ACTIVE_COMPARATOR

MenACWY-TT

Intervention Type BIOLOGICAL

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

Interventions

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Menveo

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

Intervention Type BIOLOGICAL

MenACWY-TT

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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

Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes