A randomised, double-blind, controlled trial of the immunogenicity and tolerability of a meningococcal group C conjugate vaccine in young British infants.
A double-blind, randomised, controlled trial was conducted in 248 British infants to assess the immunogenicity and tolerability of three doses of a meningococcal group C/CRM (197) conjugate vaccine (Lederle Laboratories, USA) given at 2, 3 and 4 months. Control children received three doses of Hepatitis B vaccine (Engerix B(R); SmithKline Beecham). At 5 months of age, 100% of children receiving the conjugate vaccine had specific immunoglobulin G concentrations >2.0 microg/ml (n=116) compared with only 4% of control children (n=121). Those receiving the conjugate also had 2.5- and 1.6-fold higher geometric mean concentrations of PRP and diphtheria antibodies, respectively. The vaccine was well tolerated.
English
M
M
Oxford Vaccine Group, University of Oxford, John Radcliffe Hospital, Headington, Oxford, UK. menglish@kilifi.mimcom.net
MacLennan
J M
JM
Bowen-Morris
J M
JM
Deeks
J
J
Boardman
M
M
Brown
K
K
Smith
S
S
Buttery
J
J
Clarke
J
J
Quataert
S
S
Lockhart
S
S
Moxon
E R
ER
D000907:Antibodies, Bacterial / Q000097:blood; D001770:Blood Bactericidal Activity; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000009:adverse effects / Q000276:immunology*; D009345:Neisseria meningitidis / Q000276:immunology; D018074:Vaccines, Conjugate / Q000276:immunology
D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate