TY - JOUR
T1 - Quadrivalent meningococcal (MenACWY-TT) conjugate vaccine or a fourth dose of H. influenzae-N. meningitidis C/Y conjugate vaccine (HibMenCY-TT) is immunogenic in toddlers who previously received three doses of HibMenCY-TT in infancy
AU - Leonardi, Michael
AU - Latiolais, Thomas
AU - Sarpong, Kwabena
AU - Simon, Michael
AU - Twiggs, Jerry
AU - Lei, Paul
AU - Rinderknecht, Stephen
AU - Blatter, Mark
AU - Bianco, Veronique
AU - Baine, Yaela
AU - Friedland, Leonard R.
AU - Miller, Jacqueline M.
N1 - Funding Information:
Authors’ contributions : M. Leonardi, T. Latiolais, K. Sarpong, M. Simon, J. Twiggs, P. Lei, S. Rinderknecht and M. Blatter were investigators involved in the supervision of the study, administrative, logistic and technical supports, the recruitment and the medical evaluation of subjects, the evaluation of any reported AEs/SAEs for severity and causality, the collection and interpretation of the data, and the drafting and approval of the manuscript. Dr JM. Miller, Dr Y. Baine (clinical development scientists), Dr LR. Friedland (US clinical development) and V. Bianco (biostatistician) are employed by GlaxoSmithKline Vaccines and were involved in all stages of the study (study design, data analyses and interpretations, drafting and approval of the manuscript). Conflicts of interest : The institutions of Dr M. Blatter, Dr S. Rinderknecht and Dr M. Leonardi received support for travel or accommodation expenses from GlaxoSmithKline group of companies. The institutions of Dr M. Blatter and Dr S Kwabena received grants from GlaxoSmithKline group of companies. Dr M. Blatter received compensations for lectures from GlaxoSmithKline group of companies, Sanofi and Novartis. Dr P. Lei is paid by The Pharmaceutical Research Organization which has contracted with GlaxoSmithKline group of companies. Dr L. Friedland, Dr Y. Baine, V. Bianco and Dr J. Miller are employees of GlaxoSmithKline group of companies. Dr L. Friedland, Dr Y. Baine, and Dr J. Miller declare stock ownership in GlaxoSmithKline group of companies. Dr M. Simon, Dr T. Latiolais and Dr J. Twiggs have no conflict of interest to disclose. Funding : This work was supported by GlaxoSmithKline Biologicals SA . GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the study conduct and analysis. GlaxoSmithKline Biologicals SA also funded all costs associated with the development and the publishing of the present manuscript. All authors had full access to the data and the corresponding author was responsible for submission of the publication. Trademarks : INFANRIX, PEDIARIX, MENHIBRIX and NIMENRIX are trademarks of the GlaxoSmithKline group of companies. ACTHIB and MENACTRA are trademarks of Sanofi Pasteur. MENVEO is a trademark of Novartis.
Publisher Copyright:
© 2014 The Authors.
PY - 2015/2/11
Y1 - 2015/2/11
N2 - Background: Immunogenicity and safety of a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT were evaluated in the second year of life in HibMenCY-TT-primed toddlers. Methods: Healthy infants were randomized (5:1) and primed at 2, 4 and 6 months of age with HibMenCY-TT and diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus (DTaP-HBV-IPV) vaccine; or Hib-TT and DTaP-HBV-IPV (control). Recipients of HibMenCY-TT. +. DTaP-HBV-IPV were re-randomized (2:2:1) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months; MenACWY-TT co-administered with DTaP at 15-18 months; or HibMenCY-TT at 12-15 months and DTaP at 15-18 months. Controls received DTaP only at 15-18 months due to Hib conjugate vaccine shortage. Serum bactericidal activity using human complement (hSBA) and safety were assessed one month after meningococcal vaccination. Results: After vaccination with MenACWY-TT at 12-15 months or MenACWY-TT. +. DTaP at 15-18 months, all subjects previously primed for serogroups C/Y had hSBA ≥1:8 for these serogroups. At least 96.1% also had hSBA ≥1:8 for serogroups A/W. All subjects in the HibMenCY-TT group had hSBA ≥1:8 for serogroups C/Y. All pre-defined statistical criteria for meningococcal immunogenicity were satisfied. All vaccination regimens had acceptable safety profiles. Conclusion: Children primed with three doses of HibMenCY-TT who then received a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT had robust increases in hSBA titers for serogroups C/Y. These data provide support that MenACWY-TT, given with or without the fourth scheduled dose of DTaP could be administered as an alternative to a fourth dose of HibMenCY-TT in the second year of life.This study (110870/110871) is registered at www.clinicaltrials.gov NCT00614614.
AB - Background: Immunogenicity and safety of a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT were evaluated in the second year of life in HibMenCY-TT-primed toddlers. Methods: Healthy infants were randomized (5:1) and primed at 2, 4 and 6 months of age with HibMenCY-TT and diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus (DTaP-HBV-IPV) vaccine; or Hib-TT and DTaP-HBV-IPV (control). Recipients of HibMenCY-TT. +. DTaP-HBV-IPV were re-randomized (2:2:1) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months; MenACWY-TT co-administered with DTaP at 15-18 months; or HibMenCY-TT at 12-15 months and DTaP at 15-18 months. Controls received DTaP only at 15-18 months due to Hib conjugate vaccine shortage. Serum bactericidal activity using human complement (hSBA) and safety were assessed one month after meningococcal vaccination. Results: After vaccination with MenACWY-TT at 12-15 months or MenACWY-TT. +. DTaP at 15-18 months, all subjects previously primed for serogroups C/Y had hSBA ≥1:8 for these serogroups. At least 96.1% also had hSBA ≥1:8 for serogroups A/W. All subjects in the HibMenCY-TT group had hSBA ≥1:8 for serogroups C/Y. All pre-defined statistical criteria for meningococcal immunogenicity were satisfied. All vaccination regimens had acceptable safety profiles. Conclusion: Children primed with three doses of HibMenCY-TT who then received a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT had robust increases in hSBA titers for serogroups C/Y. These data provide support that MenACWY-TT, given with or without the fourth scheduled dose of DTaP could be administered as an alternative to a fourth dose of HibMenCY-TT in the second year of life.This study (110870/110871) is registered at www.clinicaltrials.gov NCT00614614.
KW - ACWY
KW - Conjugate vaccine
KW - HibMenCY
KW - Quadrivalent meningococcal vaccine
KW - Serum bactericidal activity
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U2 - 10.1016/j.vaccine.2014.08.027
DO - 10.1016/j.vaccine.2014.08.027
M3 - Article
C2 - 25152325
AN - SCOPUS:84921665400
SN - 0264-410X
VL - 33
SP - 933
EP - 941
JO - Vaccine
JF - Vaccine
IS - 7
ER -