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Immunogenicity and Safety of a Combination Pneumococcal-Meningococcal Vaccine in Infants
A Randomized Controlled Trial
Jim P. Buttery, FRACP;
Anna Riddell, MRCPCH;
Jodie McVernon, PhD;
Tracey Chantler, RN;
Laura Lane, RN;
Jane Bowen-Morris, RN;
Linda Diggle, MSc;
Rhonwen Morris, MPH;
Anthony Harnden, FRCPCH;
Steven Lockhart, DM;
Andrew J. Pollard, PhD;
Keith Cartwright, FRCPath;
E. Richard Moxon, FRCP
JAMA. 2005;293:1751-1758.
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<.001). The proportion with group C meningococcal SBT greater than 1:8 was lower in the Pnc9-MenC vs the MenC group (95% vs 100%, P = .05). The geometric mean concentration of antibodies to concomitantly administered Hib vaccine was reduced in the Pnc9-MenC vs the MenC group (2.11 [95% CI, 1.57-2.84] µg/mL vs 3.36 [95% CI, 2.57-4.39] µg/mL; P = .02), as were antibodies against diphtheria (0.74 [95% CI, 0.63-0.87] µg/mL vs 1.47 [95% CI, 1.28-1.69] µg/mL; P<.001). Pnc9-MenC was immunogenic for each of 9 contained pneumococcal serotypes, with responses greater than 0.35 µg/mL observed in more than 88% of infants. Increased irritability and decreased activity were observed after the third dose in the Pnc9-MenC group.
Conclusions Pnc9-MenC combination vaccine administered to infants at ages 2, 3, and 4 months demonstrated reduced group C meningococcal immunogenicity compared with MenC vaccine. The immunogenicity of concomitantly administered Hib and DTwP vaccines was also diminished. The Pnc9-MenC vaccine was safe and immunogenic for all contained pneumococcal serotypes. The reduced MenC immunogenicity may limit the development of the Pnc9-MenC vaccine.
Author Affiliations: Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Department of Paediatrics (Drs Buttery, Riddell, McVernon, Pollard, and Moxon and Mss Chantler, Lane, Bowen-Morris, and Diggle) and Department of Primary Health Care (Dr Harnden), University of Oxford, Churchill Hospital, Headington, Oxford, UK; Public Health Laboratory, Gloucestershire Royal Hospital, Gloucester, UK (Ms Morris and Dr Cartwright); and Wyeth Vaccines, Huntercombe Lane South, Taplow, Maidenhead, UK (Dr Lockhart). Dr Buttery is now with the Department of General Medicine, Murdoch Childrens Research Institute, University of Melbourne Department of Paediatrics, Royal Children’s Hospital, Melbourne, Australia.
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