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Can we Reduce the Number of Vaccine Injections for Children? (MALTA)

Primary Purpose

Invasive Meningococcal Disease

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine

Routine schedule immunisations except monovalent MenC vaccine

About this trial

This is an interventional prevention trial for Invasive Meningococcal Disease focused on measuring meningococcal serogroup C, vaccine, conjugate

Eligibility Criteria

2 Months - 3 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
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.

Sites / Locations

Oxford Vaccine Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Two Dose MenC Group

Single Dose MenC-CRM197 Group

Single Dose MenC-TT Group

Control Group

Arm Description

Two doses of MenC-CRM197 priming at 3 and 4 months of age.

One dose of MenC-CRM197 priming at 3 months of age.

Single dose MenC-TT priming at 3 months of age

Zero dose MenC priming

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01129518

First Posted

May 21, 2010

Last Updated

November 6, 2015

Sponsor

University of Oxford

Collaborators

Oxford University Hospitals NHS Trust, GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01129518

Brief Title

Can we Reduce the Number of Vaccine Injections for Children?

Acronym

MALTA

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

Collaborators

Oxford University Hospitals NHS Trust, GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Invasive Meningococcal Disease

Keywords

meningococcal serogroup C, vaccine, conjugate

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

404 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Two Dose MenC Group

Arm Type

Experimental

Arm Description

Two doses of MenC-CRM197 priming at 3 and 4 months of age.

Arm Title

Single Dose MenC-CRM197 Group

Arm Type

Experimental

Arm Description

One dose of MenC-CRM197 priming at 3 months of age.

Arm Title

Single Dose MenC-TT Group

Arm Type

Experimental

Arm Description

Single dose MenC-TT priming at 3 months of age

Arm Title

Control Group

Arm Type

Experimental

Arm Description

Zero dose MenC priming

Intervention Type

Biological

Intervention Name(s)

Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Routine schedule immunisations except monovalent MenC vaccine

Intervention Description

Routine schedule immunisations will be given according to NHS guidelines.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

3 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Facility Information:

Facility Name

Oxford Vaccine Group

City

Oxford

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28029540

Citation

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.

Results Reference

derived

PubMed Identifier

25832102

Citation

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. Erratum In: BMJ. 2016 May 06;353:i2605.

Results Reference

derived

PubMed Identifier

25577661

Citation

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.

Results Reference

derived

PubMed Identifier

25020050

Citation

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.

Results Reference

derived

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