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Original Contribution
June 7, 2000

Safety, Immunogenicity, and Induction of Immunologic Memory by a Serogroup C Meningococcal Conjugate Vaccine in Infants: A Randomized Controlled Trial

Author Affiliations

Author Affiliations: Oxford Vaccine Group, Department of Paediatrics, John Radcliffe Hospital (Drs MacLennan, Shackley, Heath, Herbert, Griffiths, and Moxon, and Ms Flamank) and Centre for Statistics in Medicine (Mr Deeks), Oxford, England; and Chiron Vaccines, Amsterdam, the Netherlands (Dr Hatzmann) and Chiron Vaccines, Siena, Italy (Dr Goilav). Dr Shackley is now with the Department of Paediatrics Royal Hospital for Sick Children, Glasgow, Scotland, and Dr Heath is now with the Department of Child Health and St Georges Vaccine Institute, St Georges Hospital Medical School, London, England.

JAMA. 2000;283(21):2795-2801. doi:10.1001/jama.283.21.2795

Context Neisseria meningitidis is a common cause of meningitis and septicemia in infants worldwide. Whether a meningococcal C conjugate vaccine protects infants against the serogroup C strain is unknown.

Objectives To determine whether a meningococcal C conjugate vaccine is safe and immunogenic and induces immunologic memory in infants.

Design Single-center, double-blind, randomized controlled trial in 1995 and 1996.

Setting Community, Oxfordshire, England.

Participants One hundred eighty-two healthy infants.

Interventions Participants were randomly assigned to receive vaccination with 0.5-mL doses of 1 of 2 lots of meningococcal C conjugate vaccine (groups 1 and 2; n=60 in each group) or a hepatitis B control vaccine (group 3; n=62), administered with routine immunizations at 2, 3, and 4 months of age. Approximately half of each group received meningococcal C conjugate vaccine and half received plain meningococcal polysaccharide vaccine (MPS) at 12 months of age.

Main Outcome Measures Serum antibodies to meningococcal C polysaccharide, assayed by enzyme-linked immunosorbent assay, and serum bactericidal activity (SBA), at 2, 3, 4, 5, 12, and 13 months of age; local and systemic reactions, recorded for 6 days after each vaccination, compared by intervention group.

Results Meningococcal C conjugate vaccine was well tolerated. After 3 doses, children in groups 1 and 2 achieved significantly higher meningococcal C IgG geometric mean concentrations (21 and 17 U/mL, respectively, vs 0.20 U/mL; P<.001) and SBA titers (629 and 420, respectively, vs 4.1; P<.001) than controls. At 12 months, antibody concentrations had decreased in all groups but remained significantly higher in children vaccinated with meningococcal C conjugate vaccine (SBA, 24 and 16 in groups 1 and 2, respectively, vs 4.2 in group 3; P<.001). Following vaccination with MPS at 12 months of age, SBA in the meningococcal C conjugate vaccine group was significantly higher than in controls (SBA, 789 vs 4.5; P<.001).

Conclusions Our data indicate that meningococcal C conjugate vaccine is safe and immunogenic and results in immunologic memory when given with other routinely administered vaccines to infants at 2, 3, and 4 months of age.