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
  Purpose

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.


Condition Intervention Phase
Invasive Meningococcal Disease
Biological: Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine
Biological: Routine schedule immunisations except monovalent MenC vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 498
Study Start Date: June 2010
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Two Dose MenC Group
Two doses of MenC-CRM197 priming at 3 and 4 months of age.
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.
Experimental: Single Dose MenC-CRM197 Group
One dose of MenC-CRM197 priming at 3 months of age.
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.
Experimental: Single Dose MenC-TT Group
Single dose MenC-TT priming at 3 months of age
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.
Experimental: Control Group
Zero dose MenC priming
Biological: Routine schedule immunisations except monovalent MenC vaccine
Routine schedule immunisations will be given according to NHS guidelines.

  Eligibility

Ages Eligible for Study:   2 Months to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129518

Locations
United Kingdom
Oxford Vaccine Group
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford
Oxford University Hospitals NHS Trust
GlaxoSmithKline
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01129518     History of Changes
Other Study ID Numbers: 2008_06
Study First Received: May 21, 2010
Last Updated: January 28, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
meningococcal serogroup C
vaccine
conjugate

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 26, 2014