Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age

Nolan, T.M., Nissen, M.D., Naz, A., Shepard, J., Bedell, L., Hohenboken, M., Odrljin, T. and Dull, P.M. (2014) Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age. Human Vaccines and Immunotherapeutics, 10 2: 280-289. doi:10.4161/hv.27051

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Author Nolan, T.M.
Nissen, M.D.
Naz, A.
Shepard, J.
Bedell, L.
Hohenboken, M.
Odrljin, T.
Dull, P.M.
Title Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age
Journal name Human Vaccines and Immunotherapeutics   Check publisher's open access policy
ISSN 2164-554X
2164-5515
Publication date 2014-01-01
Sub-type Article (original research)
DOI 10.4161/hv.27051
Volume 10
Issue 2
Start page 280
End page 289
Total pages 10
Place of publication Philadelphia, PA, U.S.A.
Publisher Landes Bioscience
Collection year 2015
Language eng
Subject 2723 Immunology and Allergy
2403 Immunology
3004 Pharmacology
Abstract Background: Infants are at the highest risk for meningococcal disease and a broadly protective and safe vaccine is an unmet need in this youngest population. We evaluated the immunogenicity and safety of a 4-dose infant/toddler regimen of MenAC WY-CRM given at 2, 4, 6, and 12 months of age concomitantly with pentavalent diphtheria-tetanusacellular pertussis-Hemophilus influenzae type b-inactivated poliovirus-combination vaccine (DTaP-IPV/Hib), hepatitis B vaccine (HBV), 7- or 13-valent conjugate pneumococcal vaccine (PCV), and measles, mumps, and rubella vaccine (MMR). Results: Four doses of MenAC WY-CRM induced hSBA titers ?8 in 89%, 95%, 97%, and 96% of participants against serogroups A, C, W-135, and Y, respectively. hSBA titers ?8 were present in 7698% of participants after the first 3 doses. A categorical linear analysis incorporating vaccine group and study center showed responses to routine vaccines administered with MenAC WY-CRM were non-inferior to routine vaccines alone, except for seroresponse to the pertussis antigen fimbriae. The reactogenicity profile was not affected when MenAC WY-CRM was administered concomitantly with routine vaccines. Conclusion: MenAC WY-CRM administered with routine concomitant vaccinations in young infants was well tolerated and induced highly immunogenic responses against each of the serogroups without significant interference with the immune responses to routine infant vaccinations. Methods: Healthy 2 month old infants were randomized to receive MenAC WY-CRM with routine vaccines (n = 258) or routine vaccines alone (n = 271). Immunogenicity was assessed by serum bactericidal assay using human complement (hSBA). Medically attended adverse events (AEs), serious AEs (SAE s) and AEs leading to study withdrawal were collected throughout the study period.
Keyword Conjugate vaccine
Immunogenicity
Infants
Meningococcal disease
Safety
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
Queensland Children's Medical Research Institute Publications
School of Medicine Publications
 
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Created: Thu, 08 Jan 2015, 01:56:15 EST by Matthew Lamb on behalf of School of Medicine