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https://hdl.handle.net/2440/66719
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Type: | Journal article |
Title: | Immunogenicity and safety of an investigational combined haemophilus influenzae Type B-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine |
Author: | Nolan, T. Richmond, P. Marshall, H. McVernon, J. Alexander, K. Mesaros, N. Aris, E. Miller, J. Poolman, J. Boutriau, D. |
Citation: | The Pediatric Infectious Disease Journal, 2011; 30(3):190-196 |
Publisher: | Lippincott Williams & Wilkins |
Issue Date: | 2011 |
ISSN: | 0891-3668 1532-0987 |
Statement of Responsibility: | Terry Nolan, Peter Richmond, Helen Marshall, Jodie McVernon, Karyn Alexander, Narcisa Mesaros, Emmanuel Aris, Jacqueline Miller, Jan Poolman, and Dominique Boutriau |
Abstract: | Background: Neisseria meningitidis serogroups B, C, and Y cause most meningococcal disease in industrialized countries. A Haemophilus influenzae type b-meningococcal serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) was evaluated. Methods: A total of 1104 infants (randomized 3:1:1) were vaccinated at 2, 4, and 6 months with HibMenCY-TT, MenC-CRM197 + Hib-TT, or Hib-TT. At 12 to 15 months, HibMenCY-TT and MenC-CRM-primed children received HibMenCY-TT; Hib-TT-primed received N. meningitidis serogroup B Hib-outer membrane protein complex. Antibody concentrations and rabbit/human complement serum bactericidal antibody titers (rSBA/hSBA) were determined. Safety was monitored after each dose (diary cards for first 31 days) until 6 months postdose 4. Results: Postdose 3, rates of antipolyribosylribitol phosphate >=1 µg/mL and rSBA-MenC >=1:128 in HibMenCY-TT recipients were noninferior to licensed controls. Percentages reaching 0.15 µg/mL (1.0 µg/mL postdose 3) and antipolyribosylribitol phosphate GMC were significantly higher after HibMenCY-TT than Hib-TT postdose 2 and postdose 3. The GMC remained significantly higher before and after dose 4. Proportions of HibMenCY-TT recipients with rSBA >=1:8 were 95.6% (MenC), 98.6% (MenY) postdose-2, >=99% for MenC/Y postdose 3 and 4; hSBA >=1:4 were 95.5% (MenC), 89.8% (MenY) postdose 2, >97% for MenC/Y postdose 3 and 4. HibMenCY-TT had a similar safety profile to control vaccines. Conclusions: HibMenCY-TT induced noninferior Hib and MenC responses compared with monovalent Hib and MenC conjugates with a comparable safety profile. Bactericidal antibodies against MenC/Y were induced after 2 doses of HibMenCY-TT. |
Keywords: | Haemophilus influenzae type b meningitis Neisseria meningitidis serogroups C and Y combination vaccine primary vaccination booster |
Rights: | Copyright: © 2011 Lippincott Williams & Wilkins, Inc. |
DOI: | 10.1097/INF.0b013e3181fcb2bf |
Published version: | http://dx.doi.org/10.1097/inf.0b013e3181fcb2bf |
Appears in Collections: | Aurora harvest Paediatrics publications |
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