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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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Invasive Meningococcal Disease
Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine, Routine schedule immunisations except monovalent MenC vaccine
Oxford Vaccine Group
Not yet recruiting
University of Oxford
Published on BioPortfolio: 2014-08-27T03:13:27-0400
The purpose of this study in healthy toddlers who have not previously been immunized against MenC infection and who completed their primary immunization series with PCV-7 (3 vaccinations) ...
This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, a...
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningo...
The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 mo...
The purpose of this booster vaccination study is to evaluate the persistence and immune memory induced by a three-dose primary vaccination course with GSK Biologicals’ MenC-TT (Neisseria...
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[This corrects the article DOI: 10.1371/journal.pone.0063605.].
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Strains of Neisseria meningitidis which are the most common ones causing infections or disease in infants. Serogroup B strains are isolated most frequently in sporadic cases, and are less common in outbreaks and epidemics.
Strains of Neisseria meningitidis which, in the United States, causes disease in mostly adults and the elderly. Serogroup Y strains are associated with PNEUMONIA.
Strains of Neisseria meningitidis found mostly in Africa.
A pneumococcal vaccine which 7 pneumococcal serotypes (6B, 14, 19F, 23F, 18C, 4, 9V), each conjugated individually to the outer membrane protein complex of NEISSERIA MENINGITIDIS.
Strains of Neisseria meningitidis responsible for most sporadic cases in teenagers and almost all outbreaks of disease in this age group. These strains are less common in infants.
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...
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