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Clinical 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. 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01129518
Study type Interventional
Source University of Oxford
Contact
Status Completed
Phase Phase 4
Start date June 2010

See also
  Status Clinical Trial Phase
Completed NCT01732627 - Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older Phase 2
Recruiting NCT04184336 - Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada
Completed NCT01272180 - Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults Phase 2