Meningococcal MeningitisPhase 2/3PRIMENCT01192997
Comparison of Two Meningococcal ACWY Conjugate Vaccines
A Phase 2/3 study testing Menveo and MenACWY-TT in people with Meningococcal Meningitis, run by Public Health England at 3 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Meningitis
- What is being tested?
- Menveo and MenACWY-TT
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jun 2012to Mar 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Multiple General Practice surgeries
Gloucester, Gloucestershire
Multiple General Practice surgeries
Hertford, Hertfordshire
Health Protection Agency, Immunisation Department, Colindale
London, NW9 5EQ
About this study
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
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).
- Conditions
- Meningococcal Meningitis
- Being tested
- Menveo, MenACWY-TT
- Keywords
- Meningitis, Meningococci, Meningitis C, Meningitis A, Meningitis W135, Meningitis Y, Antibody
- Medical subject headings
- Meningitis, Meningococcal, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenveoBiological
Single dose Menveo (a MenACWY vaccine conjugated to CRM-197).
MenACWY-TTBiological
Single dose MenACWY-TT (MenACWY vaccine conjugated to Tetanus Toxoid, TT)
| Study group | Role | What they receive |
|---|---|---|
| Menveo-Meningitec | Active comparator | Subjects who were primed with Meningitec who will receive Novartis Menveo Receives: Biological: Menveo |
| MenACWY-TT-Meningitec | Active comparator | Subjects who were primed with Meningitec who will receive GSK MenACWY-TT Receives: Biological: MenACWY-TT |
| Menveo-Menjugate | Active comparator | Subjects who were primed with Menjugate who will receive Novartis Menveo Receives: Biological: Menveo |
| MenACWY-TT-Menjugate | Active comparator | Subjects who were primed with Menjugate who will receive GSK MenACWY-TT vaccine. Receives: Biological: MenACWY-TT |
| Menveo-NeisVac-C | Active comparator | Subjects who were primed with NeisVac-C who will receive Novartis Menveo Receives: Biological: Menveo |
| MenACWY-TT-NeisVac-C | Active comparator | Subjects who were primed with NeisVac-C who will receive GSK MenACWY-TT vaccine Receives: Biological: MenACWY-TT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: December 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startJun 2012
- Primary completionOct 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningococcal MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elizabeth Miller, MD, Study chair, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192997
- Sponsor's protocol ID
- PRIME
- Acronym
- PRIME
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2010
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01192997
- Acronym / sponsor ID
- PRIME / PRIME
- Conditions
- Meningococcal Meningitis
- Keywords
- Meningitis, Meningococci, Meningitis C, Meningitis A, Meningitis W135, Meningitis Y, Antibody
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Jun 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Menveo-Meningitec | Active comparator | Biological: MenveoSubjects who were primed with Meningitec who will receive Novartis Menveo |
| MenACWY-TT-Meningitec | Active comparator | Biological: MenACWY-TTSubjects who were primed with Meningitec who will receive GSK MenACWY-TT |
| Menveo-Menjugate | Active comparator | Biological: MenveoSubjects who were primed with Menjugate who will receive Novartis Menveo |
| MenACWY-TT-Menjugate | Active comparator | Biological: MenACWY-TTSubjects who were primed with Menjugate who will receive GSK MenACWY-TT vaccine. |
| Menveo-NeisVac-C | Active comparator | Biological: MenveoSubjects who were primed with NeisVac-C who will receive Novartis Menveo |
| MenACWY-TT-NeisVac-C | Active comparator | Biological: MenACWY-TTSubjects who were primed with NeisVac-C who will receive GSK MenACWY-TT vaccine |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenveoSingle dose Menveo (a MenACWY vaccine conjugated to CRM-197). | Biological | Menveo-Meningitec, Menveo-Menjugate, Menveo-NeisVac-C |
| MenACWY-TTSingle dose MenACWY-TT (MenACWY vaccine conjugated to Tetanus Toxoid, TT) | Biological | MenACWY-TT-Meningitec, MenACWY-TT-Menjugate, MenACWY-TT-NeisVac-C |
Primary outcome
Response to meningococcal components of the vaccines by serum bactericidal antibody
Time frame: December 2013
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Results publication: PubMed 26075813Ishola 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.
- Published study resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Miller, MD study chair
Public Health England
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Menveo and MenACWY-TT in people with Meningococcal Meningitis, run by Public Health England at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to meningococcal components of the vaccines by serum bactericidal antibody (time frame: December 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.