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Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age.
Hum Vaccin Immunother. 2014; 10(2):280-9.HV

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 MenACWY-CRM given at 2, 4, 6, and 12 months of age concomitantly with pentavalent diphtheria-tetanus-acellular 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 MenACWY-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 76-98% of participants after the first 3 doses. A categorical linear analysis incorporating vaccine group and study center showed responses to routine vaccines administered with MenACWY-CRM were non-inferior to routine vaccines alone, except for seroresponse to the pertussis antigen fimbriae. The reactogenicity profile was not affected when MenACWY-CRM was administered concomitantly with routine vaccines.

CONCLUSION

MenACWY-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 MenACWY-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 (SAEs) and AEs leading to study withdrawal were collected throughout the study period.

Authors+Show Affiliations

Vaccine and Immunisation Research Group (VIRGo); Melbourne School of Population and Global Health; University of Melbourne and Murdoch Children's Research Institute; Melbourne, VIC Australia.Queensland Paediatric Infectious Diseases Laboratory; Queensland Children's Medical Research Institute, Royal Children's Hospital; Brisbane, QLD Australia.Madera Family Medical Group; Madera, CA USA.Ohio Pediatric Research Association; Vandalia, OH USA.Novartis Vaccines and Diagnostics; Cambridge, MA USA.Novartis Vaccines and Diagnostics; Cambridge, MA USA.Novartis Vaccines and Diagnostics; Cambridge, MA USA.Novartis Vaccines and Diagnostics; Cambridge, MA USA.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

24220326

Citation

Nolan, Terry M., et al. "Immunogenicity and Safety of a CRM-conjugated Meningococcal ACWY Vaccine Administered Concomitantly With Routine Vaccines Starting at 2 Months of Age." Human Vaccines & Immunotherapeutics, vol. 10, no. 2, 2014, pp. 280-9.
Nolan TM, Nissen MD, Naz A, et al. Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age. Hum Vaccin Immunother. 2014;10(2):280-9.
Nolan, T. M., Nissen, M. D., Naz, A., Shepard, J., Bedell, L., Hohenboken, M., Odrljin, T., & 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 & Immunotherapeutics, 10(2), 280-9. https://doi.org/10.4161/hv.27051
Nolan TM, et al. Immunogenicity and Safety of a CRM-conjugated Meningococcal ACWY Vaccine Administered Concomitantly With Routine Vaccines Starting at 2 Months of Age. Hum Vaccin Immunother. 2014;10(2):280-9. PubMed PMID: 24220326.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a CRM-conjugated meningococcal ACWY vaccine administered concomitantly with routine vaccines starting at 2 months of age. AU - Nolan,Terry M, AU - Nissen,Michael D, AU - Naz,Aftab, AU - Shepard,Julie, AU - Bedell,Lisa, AU - Hohenboken,Matthew, AU - Odrljin,Tatjana, AU - Dull,Peter M, Y1 - 2013/11/12/ PY - 2013/11/14/entrez PY - 2013/11/14/pubmed PY - 2015/1/6/medline KW - conjugate vaccine KW - immunogenicity KW - infants KW - meningococcal disease KW - safety SP - 280 EP - 9 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 10 IS - 2 N2 - 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 MenACWY-CRM given at 2, 4, 6, and 12 months of age concomitantly with pentavalent diphtheria-tetanus-acellular 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 MenACWY-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 76-98% of participants after the first 3 doses. A categorical linear analysis incorporating vaccine group and study center showed responses to routine vaccines administered with MenACWY-CRM were non-inferior to routine vaccines alone, except for seroresponse to the pertussis antigen fimbriae. The reactogenicity profile was not affected when MenACWY-CRM was administered concomitantly with routine vaccines. CONCLUSION: MenACWY-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 MenACWY-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 (SAEs) and AEs leading to study withdrawal were collected throughout the study period. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/24220326/Immunogenicity_and_safety_of_a_CRM_conjugated_meningococcal_ACWY_vaccine_administered_concomitantly_with_routine_vaccines_starting_at_2_months_of_age_ DB - PRIME DP - Unbound Medicine ER -