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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Oxford University Hospitals NHS Trust

GlaxoSmithKline

Information provided by (Responsible Party):

University of Oxford

ClinicalTrials.gov Identifier:

NCT01129518

First received: May 21, 2010

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	May 21, 2010
Last Updated Date	January 28, 2013
Start Date ^ICMJE	June 2010
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 21, 2010)	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 ] [ Designated as safety issue: No ] 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).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01129518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Can we Reduce the Number of Vaccine Injections for Children?
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Invasive Meningococcal Disease
Intervention ^ICMJE	Biological: Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine 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. Biological: Routine schedule immunisations except monovalent MenC vaccine Routine schedule immunisations will be given according to NHS guidelines.
Study Arm (s)	Experimental: Two Dose MenC Group Two doses of MenC-CRM197 priming at 3 and 4 months of age. Interventions: Biological: Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine Biological: Routine schedule immunisations except monovalent MenC vaccine Experimental: Single Dose MenC-CRM197 Group One dose of MenC-CRM197 priming at 3 months of age. Interventions: Biological: Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine Biological: Routine schedule immunisations except monovalent MenC vaccine Experimental: Single Dose MenC-TT Group Single dose MenC-TT priming at 3 months of age Interventions: Biological: Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine Biological: Routine schedule immunisations except monovalent MenC vaccine Experimental: Control Group Zero dose MenC priming Intervention: Biological: Routine schedule immunisations except monovalent MenC vaccine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	498
Completion Date	Not Provided
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	2 Months to 3 Months
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01129518
Other Study ID Numbers ^ICMJE	2008_06
Has Data Monitoring Committee	No
Responsible Party	University of Oxford
Study Sponsor ^ICMJE	University of Oxford
Collaborators ^ICMJE	Oxford University Hospitals NHS Trust GlaxoSmithKline
Investigators ^ICMJE	Not Provided
Information Provided By	University of Oxford
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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