Immunogenicity and Safety of a Combination Pneumococcal-Meningococcal Vaccine in Infants: A Randomized Controlled Trial

CONTEXT The success of conjugate vaccines in decreasing invasive disease due to Streptococcus pneumoniae and group C Neisseria meningitidis has placed pressure on crowded infant immunization schedules, making development of combination vaccines a priority. OBJECTIVE To determine the safety and immun...

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Bibliographic Details
Published in:JAMA : the journal of the American Medical Association 2005-04, Vol.293 (14), p.1751-1758
Main Authors: Buttery, Jim P, Riddell, Anna, McVernon, Jodie, Chantler, Tracey, Lane, Laura, Bowen-Morris, Jane, Diggle, Linda, Morris, Rhonwen, Harnden, Anthony, Lockhart, Steven, Pollard, Andrew J, Cartwright, Keith, Moxon, E. Richard
Format: Article
Language:English
Subjects:
Antibodies, Bacterial - biosynthesis
Babies
Bacteria
Biological and medical sciences
Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage
Diphtheria-Tetanus-Pertussis Vaccine - immunology
Female
General aspects
Haemophilus influenzae
Haemophilus Vaccines - administration & dosage
Haemophilus Vaccines - immunology
Humans
Immunization
Immunology
Infant
Male
Medical sciences
Meningococcal Vaccines - administration & dosage
Meningococcal Vaccines - adverse effects
Meningococcal Vaccines - immunology
Neisseria meningitidis
Neisseria meningitidis, Serogroup C - immunology
Pneumococcal Vaccines - administration & dosage
Pneumococcal Vaccines - adverse effects
Pneumococcal Vaccines - immunology
Poliovirus Vaccine, Oral - administration & dosage
Poliovirus Vaccine, Oral - immunology
Streptococcus pneumoniae
Streptococcus pneumoniae - immunology
Tetanus Toxoid - administration & dosage
Tetanus Toxoid - immunology
Vaccines
Vaccines, Combined
Vaccines, Conjugate
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Summary:CONTEXT The success of conjugate vaccines in decreasing invasive disease due to Streptococcus pneumoniae and group C Neisseria meningitidis has placed pressure on crowded infant immunization schedules, making development of combination vaccines a priority. OBJECTIVE To determine the safety and immunogenicity of a combination 9-valent pneumococcal–group C meningococcal conjugate candidate vaccine (Pnc9-MenC) administered as part of the routine UK infant immunization schedule at ages 2, 3, and 4 months. DESIGN, SETTING, AND PARTICIPANTS Phase 2 randomized controlled trial conducted from August 2000 to January 2002 and enrolling 240 healthy infants aged 7 to 11 weeks from 2 UK centers, with home follow-up visits at ages 2, 3, 4, and 5 months. INTERVENTION Pnc9-MenC (n = 120) or monovalent group C meningococcal conjugate vaccine (MenC) (n = 120) administered in addition to routine immunizations (diphtheria and tetanus toxoids and whole-cell pertussis [DTwP], Haemophilus influenzae type b [Hib] polyribosylribitol phosphate-tetanus toxoid protein conjugate, oral polio vaccine). MAIN OUTCOME MEASURES Group C meningococcal immunogenicity measured by serum bactericidal titer (SBT) 1 month following the third dose; rates of postimmunization reactions. RESULTS MenC component immunogenicity was reduced in the Pnc9-MenC vs the MenC group (geometric mean SBT, 179 [95% confidence interval {CI}, 133-243] vs 808 [95% CI, 630-1037], respectively; P
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.293.14.1751