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Invasive Meningococcal DiseasePhase 4MALTANCT01129518

Can we Reduce the Number of Vaccine Injections for Children?

A Phase 4 study testing Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine and Routine schedule immunisations except monovalent MenC vaccine in people with Invasive Meningococcal Disease, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This open label randomised controlled study will evaluate the induction of immunity following varying schedules of vaccination with glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccines in infancy. 498 infants will be enrolled in this multi-centre trial. Read more about this study

Who is it for?
Ages 2 to 3 monthsHealthy volunteers can take part
Conditions the study is for
Invasive Meningococcal Disease
What is being tested?
Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine and Routine schedule immunisations except monovalent MenC vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
404 participants
Where
1 siteUnited Kingdom
Study dates
Jun 2010to Jul 2013
Phase
Phase 4
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 2 to 3 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy male or female infants aged 6-12 weeks at the time of the first vaccination and who were born between 37 and 42 weeks of gestation
  • Infants who are known to be free from medical problems as determined by a medical history and clinical examination
  • Parents or guardians who are willing for their child to participate and who would be expected to comply with the requirements of the protocol
  • Parents/guardians who have given informed consent for their child's participation in the study

Who cannot join

  • History of invasive meningococcal C disease
  • Previous vaccination against meningococcal serogroup C disease
  • Planned administration/administration of vaccines, since birth, other than the study vaccines (with the exception of oral rotavirus vaccine, Hepatitis B vaccine and BCG).
  • Receipt of investigational vaccines/drugs, other than the vaccines used in the study, within 30 days prior to receiving the first dose of the vaccines or their planned use during the study period
  • Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
Show all 13Show fewer
  • Receipt of more than 2 weeks of immunosuppressants or immune modifying drugs, (e.g. prednisolone >0.5mg/kg/day)
  • History of allergy to any component of the vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures
  • Acute disease at the time of recruitment as defined by the presence of a moderate or severe illness with or without fever (with the exception of minor illnesses such as diarrhoea, mild upper respiratory infection without fever). In such situations enrolment should be postponed until the participant has recovered.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
  • Parents who plan to move out of the geographical area where the study would be conducted.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Oxford Vaccine Group

    Oxford

Other trials in United Kingdom

About this study

Official title: An Open Label Randomised Controlled Study to Evaluate the Induction of Immune Memory Following Infant Vaccination With a Glycoconjugate Neisseria Meningitidis Serogroup C Vaccine and to Assess the Immunological Impact of Administering Routine Infant Immunisations in Consistent Versus Alternating Limbs

This open label randomised controlled study will evaluate the induction of immunity following varying schedules of vaccination with glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccines in infancy. 498 infants will be enrolled in this multi-centre trial. Participants will receive either 0, 1, or 2 priming doses of a MenC-CRM197 conjugate vaccine or 1 priming dose of a MenC-TT conjugate vaccine in the first year of life, with all groups receiving a dose of a combination Hib-MenC-TT vaccine at 12 months, as well as all other concurrent routine vaccinations. All groups will also be further divided into 2 groups to receive their routine vaccines in either consistent or alternating limbs to assess the immune response to the concurrent infant routine immunisations administered in consistent versus alternating limbs. Immune responses will be assessed at 5, 12, 12months +6 days, 13 and 24 months of age.

Being tested
Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine, Routine schedule immunisations except monovalent MenC vaccine
Keywords
meningococcal serogroup C, vaccine, conjugate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccineBiological

    In order to ensure proper intramuscular injection of the study vaccines, a 23G (0.5mm in diameter) needle of at least 1 inch (2.54 cm) length will be used. All vaccines will be administered intramuscularly.

    Then MenC vaccine will administered either once (at 3 months) or twice (at 3 and 4 months) depending on treatment group to either the thigh, deltoid or a combination of the two.

  • Routine schedule immunisations except monovalent MenC vaccineBiological

    Routine schedule immunisations will be given according to NHS guidelines.

Study groups in NCT01129518
Study groupRoleWhat they receive
Two Dose MenC GroupExperimentalTwo doses of MenC-CRM197 priming at 3 and 4 months of age.
Receives: Biological: Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine; Biological: Routine schedule immunisations except monovalent MenC vaccine
Single Dose MenC-CRM197 GroupExperimentalOne dose of MenC-CRM197 priming at 3 months of age.
Receives: Biological: Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine; Biological: Routine schedule immunisations except monovalent MenC vaccine
Single Dose MenC-TT GroupExperimentalSingle dose MenC-TT priming at 3 months of age
Receives: Biological: Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine; Biological: Routine schedule immunisations except monovalent MenC vaccine
Control GroupExperimentalZero dose MenC priming
Receives: Biological: Routine schedule immunisations except monovalent MenC vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric mean titres (GMTs) of meningococcal serogroup C (MenC) specific serum bactericidal antibodies, using rabbit complement (rSBA)

    To demonstrate non-inferiority of the geometric mean titres (GMTs) of meningococcal serogroup C (MenC) specific serum bactericidal antibodies, using rabbit complement (rSBA), 1 month after a 12 month dose of Hib-MenC vaccine in children receiving a single dose of MenC-CRM197vaccine at 3 months of age (single dose priming) compared with those receiving 2 doses at 3 and 4 months of age (2 dose priming).

    Measured: 1 month after a 12 month dose of Hib-MenC vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionJul 2013

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01129518
Sponsor's protocol ID
2008_06
Acronym
MALTA
Status last verified
Nov 2015
First submitted
21 May 2010
Last updated
9 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • Pace D, Khatami A, Attard-Montalto S, Voysey M, Finn A, Faust SN, Heath PT, Borrow R, Snape MD, Pollard AJ. Use of a booster dose of capsular group C meningococcal glycoconjugate vaccine to demonstrate immunologic memory in children primed with one or two vaccine doses in infancy. Vaccine. 2016 Dec 7;34(50):6350-6357. doi: 10.1016/j.vaccine.2016.10.038. Epub 2016 Oct 28.

    PubMed 28029540

  • Pace D, Khatami A, McKenna J, Campbell D, Attard-Montalto S, Birks J, Voysey M, White C, Finn A, Macloed E, Faust SN, Kent AL, Heath PT, Borrow R, Snape MD, Pollard AJ. Immunogenicity of reduced dose priming schedules of serogroup C meningococcal conjugate vaccine followed by booster at 12 months in infants: open label randomised controlled trial. BMJ. 2015 Apr 1;350:h1554. doi: 10.1136/bmj.h1554.

    PubMed 25832102

  • Iro MA, Khatami A, Marshall AS, Pace D, Voysey M, McKenna J, Campbell D, Attard-Montalto S, Finn A, White C, Faust SN, Kent A, Heath PT, MacLeod E, Stanford E, Findlow H, Almond R, Bai X, Borrow R, Snape MD, Pollard AJ. Immunological effect of administration of sequential doses of Haemophilus influenzae type b and pneumococcal conjugate vaccines in the same versus alternating limbs in the routine infant immunisation schedule: an open-label randomised controlled trial. Lancet Infect Dis. 2015 Feb;15(2):172-80. doi: 10.1016/S1473-3099(14)71057-6. Epub 2015 Jan 8.

    PubMed 25577661

  • Khatami A, Clutterbuck EA, Thompson AJ, McKenna JA, Pace D, Birks J, Snape MD, Pollard AJ. Evaluation of the induction of immune memory following infant immunisation with serogroup C Neisseria meningitidis conjugate vaccines--exploratory analyses within a randomised controlled trial. PLoS One. 2014 Jul 14;9(7):e101672. doi: 10.1371/journal.pone.0101672. eCollection 2014.

    PubMed 25020050

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine and Routine schedule immunisations except monovalent MenC vaccine in people with Invasive Meningococcal Disease, run by University of Oxford at 1 site 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 4 inclusion and 13 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 9 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Geometric mean titres (GMTs) of meningococcal serogroup C (MenC) specific serum bactericidal antibodies, using rabbit complement (rSBA) (time frame: 1 month after a 12 month dose of Hib-MenC vaccine). 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 NCT01129518, which also lists 4 linked publications.

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 9 Nov 2015.

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