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Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2, 3, 4 months schedule with a fourth dose at 12-18 months of age

Pirmin Habermehl, Geert Leroux-Roels UGent, Roland Sanger, Gudrun Machler and Dominique Boutriau (2010) HUMAN VACCINES. 6(8). p.640-651
abstract
Combined HibMenCY and HibMenC conjugate vaccines may facilitate inclusion of vaccination against MenC and MenY into routine vaccination schedules, without additional injections. Immunogenicity and reactogenicity of vaccination with three different formulations of a novel HibMenCY-conjugate vaccine, or a HibMenC-conjugate vaccine was assessed. Infants were randomized to receive either Hib(2.5 mu g)-MenC(5 mu g)-MenY(5 mu g)-TT, Hib(5 mu g)-MenC(10 mu g)MenY(10 mu g)-TT, Hib(5 mu g)-MenC(5 mu g)-MenY(5 mu g)-TT or Hib(5 mu g)-MenC(5 mu g)-TT vaccines co-administered with DTPa-HBV-IPV at 2-3-4 months of age. Controls received licensed conjugate MenC-CRM197 vaccine co-administered with DTPa-HBV-IPV/Hib. A fourth dose was administered to a subset of children at age 12-18 months. Anti-PRP concentrations and meningococcal bactericidal (rSBA-MenC/Y) titers were measured prior to and one month post third and fourth vaccination dose. Solicited local, general symptoms and unsolicited adverse events were recorded for 7 and 30 days after each vaccination, respectively. Post-dose-3, all subjects had anti-PRP antibody levels >= 0.15 mu g/ml and rSBA-MenC >= 1:8. 97.0%-98.6% of HibMenCY recipients had rSBA-MenY >= 1:8. Pre-dose-4, 95.6%-100% of HibMenCY and HibMenC recipients had anti-PRP >= 0.15 mu g/ml and 90.7%-97.6% recipients had rSBA-MenC titers >= 1:8. In HibMenCY groups, 78.6%-86.7% had persisting rSBA-MenY >= 1:8. The post-dose-4 response was robust after all vaccines with all subjects having anti-PRP >= 1 mu g/ml and 92.3%-100% rSBA-MenC >= 1:128. All HibMenCY recipients had rSBA-MenY >= 1:128. Vaccination with the novel Hib-meningococcal vaccines had a safety profile similar to control. HibMenCY and HibMenC conjugate vaccine formulations given at 2-3-4 months of age with a fourth dose in the second year of life were immunogenic and had a comparable safety profile to licensed vaccines. (study 792014 and 100381; www. clinicaltrial. govID:NCT00129116).
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
CAPSULAR POLYSACCHARIDE, HEPATITIS-B, BOOSTER VACCINATION, PROTECTIVE LEVEL, meningitis, conjugate vaccine, HEXAVALENT DIPHTHERIA, COMBINATION VACCINES, SERUM ANTIBODIES, Haemophilus influenzae type b, INACTIVATED POLIOVIRUS, Neisseria meningitidis serogroup Y, Neisseria meningitidis serogroup C, ACELLULAR PERTUSSIS, MENINGOCOCCAL-C
journal title
HUMAN VACCINES
Hum. Vaccines
volume
6
issue
8
pages
640 - 651
Web of Science type
Article
Web of Science id
000282756200006
JCR category
BIOTECHNOLOGY & APPLIED MICROBIOLOGY
JCR impact factor
2.042 (2010)
JCR rank
76/158 (2010)
JCR quartile
2 (2010)
ISSN
1554-8600
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
1231200
handle
http://hdl.handle.net/1854/LU-1231200
alternative location
http://www.landesbioscience.com/journals/vaccines/article/12154/
date created
2011-05-23 17:17:21
date last changed
2016-12-19 15:44:49
@article{1231200,
  abstract     = {Combined HibMenCY and HibMenC conjugate vaccines may facilitate inclusion of vaccination against MenC and MenY into routine vaccination schedules, without additional injections. Immunogenicity and reactogenicity of vaccination with three different formulations of a novel HibMenCY-conjugate vaccine, or a HibMenC-conjugate vaccine was assessed. Infants were randomized to receive either Hib(2.5 mu g)-MenC(5 mu g)-MenY(5 mu g)-TT, Hib(5 mu g)-MenC(10 mu g)MenY(10 mu g)-TT, Hib(5 mu g)-MenC(5 mu g)-MenY(5 mu g)-TT or Hib(5 mu g)-MenC(5 mu g)-TT vaccines co-administered with DTPa-HBV-IPV at 2-3-4 months of age. Controls received licensed conjugate MenC-CRM197 vaccine co-administered with DTPa-HBV-IPV/Hib. A fourth dose was administered to a subset of children at age 12-18 months. Anti-PRP concentrations and meningococcal bactericidal (rSBA-MenC/Y) titers were measured prior to and one month post third and fourth vaccination dose. Solicited local, general symptoms and unsolicited adverse events were recorded for 7 and 30 days after each vaccination, respectively. Post-dose-3, all subjects had anti-PRP antibody levels {\textrangle}= 0.15 mu g/ml and rSBA-MenC {\textrangle}= 1:8. 97.0\%-98.6\% of HibMenCY recipients had rSBA-MenY {\textrangle}= 1:8. Pre-dose-4, 95.6\%-100\% of HibMenCY and HibMenC recipients had anti-PRP {\textrangle}= 0.15 mu g/ml and 90.7\%-97.6\% recipients had rSBA-MenC titers {\textrangle}= 1:8. In HibMenCY groups, 78.6\%-86.7\% had persisting rSBA-MenY {\textrangle}= 1:8. The post-dose-4 response was robust after all vaccines with all subjects having anti-PRP {\textrangle}= 1 mu g/ml and 92.3\%-100\% rSBA-MenC {\textrangle}= 1:128. All HibMenCY recipients had rSBA-MenY {\textrangle}= 1:128. Vaccination with the novel Hib-meningococcal vaccines had a safety profile similar to control. HibMenCY and HibMenC conjugate vaccine formulations given at 2-3-4 months of age with a fourth dose in the second year of life were immunogenic and had a comparable safety profile to licensed vaccines. (study 792014 and 100381; www. clinicaltrial. govID:NCT00129116).},
  author       = {Habermehl, Pirmin and Leroux-Roels, Geert and Sanger, Roland and Machler, Gudrun and Boutriau, Dominique},
  issn         = {1554-8600},
  journal      = {HUMAN VACCINES},
  keyword      = {CAPSULAR POLYSACCHARIDE,HEPATITIS-B,BOOSTER VACCINATION,PROTECTIVE LEVEL,meningitis,conjugate vaccine,HEXAVALENT DIPHTHERIA,COMBINATION VACCINES,SERUM ANTIBODIES,Haemophilus influenzae type b,INACTIVATED POLIOVIRUS,Neisseria meningitidis serogroup Y,Neisseria meningitidis serogroup C,ACELLULAR PERTUSSIS,MENINGOCOCCAL-C},
  language     = {eng},
  number       = {8},
  pages        = {640--651},
  title        = {Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2, 3, 4 months schedule with a fourth dose at 12-18 months of age},
  url          = {http://www.landesbioscience.com/journals/vaccines/article/12154/},
  volume       = {6},
  year         = {2010},
}

Chicago
Habermehl, Pirmin, Geert Leroux-Roels, Roland Sanger, Gudrun Machler, and Dominique Boutriau. 2010. “Combined Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroup C (HibMenC) or Serogroup C and Y-tetanus Toxoid Conjugate (and HibMenCY) Vaccines Are Well-tolerated and Immunogenic When Administered According to the 2, 3, 4 Months Schedule with a Fourth Dose at 12-18 Months of Age.” Human Vaccines 6 (8): 640–651.
APA
Habermehl, P., Leroux-Roels, G., Sanger, R., Machler, G., & Boutriau, D. (2010). Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2, 3, 4 months schedule with a fourth dose at 12-18 months of age. HUMAN VACCINES, 6(8), 640–651.
Vancouver
1.
Habermehl P, Leroux-Roels G, Sanger R, Machler G, Boutriau D. Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2, 3, 4 months schedule with a fourth dose at 12-18 months of age. HUMAN VACCINES. 2010;6(8):640–51.
MLA
Habermehl, Pirmin, Geert Leroux-Roels, Roland Sanger, et al. “Combined Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroup C (HibMenC) or Serogroup C and Y-tetanus Toxoid Conjugate (and HibMenCY) Vaccines Are Well-tolerated and Immunogenic When Administered According to the 2, 3, 4 Months Schedule with a Fourth Dose at 12-18 Months of Age.” HUMAN VACCINES 6.8 (2010): 640–651. Print.