Immunogenicity and reactogenicity of primary immunization with a novel combined Haemophilus influenzae Type b and Neisseria meningitidis Serogroup C-tetanus toxoid conjugate vaccine coadministered with a Diphtheria-tetanus-acellular Pertussis-hepatitis B-inactivated poliovirus vaccine at 2, 4 and 6 months.
BACKGROUND
This phase II study evaluated the immunogenicity and reactogenicity of primary vaccination with a novel Hib-MenC conjugate vaccine (GlaxoSmithKline [GSK] Biologicals) coadministered with DTPa-HBV-IPV (GSK Biologicals) at 2, 4 and 6 months.


METHODS
Healthy infants were randomized to receive Hib-MenC coadministered with DTPa-HBV-IPV (N = 117) or MenC-CRM (Wyeth) coadministered with DTPa-HBV-IPV/Hib (GSK Biologicals; N = 120) at 2, 4 and 6 months. Antibody concentrations were measured before vaccination and after doses 2 and 3. Solicited local and general symptoms, unsolicited symptoms and serious adverse events (SAEs) were recorded.


RESULTS
All subjects in the Hib-MenC group had seroprotective titers of anti-PRP antibodies (>or=0.15 microg/mL) and SBA-MenC titers (>or=1:8) 1 month after the third dose. These responses were noninferior to those seen in the control group, in which a 99.1% seroprotection rate was observed for both Hib and MenC. At that time, anti-PRP and SBA-MenC GMTs were significantly higher in the Hib-MenC group (12.8 microg/mL and 2467.1 microg/mL, respectively) than in the control group (3.8 microg/mL and 1833.7 microg/mL). High seroprotection rates were already observed after the second dose of Hib-MenC; 96.4% and 100% of subjects were seroprotected to Hib and MenC, respectively. Immune responses to coadministered antigens were unimpaired; seroprotection/vaccine response rates >or=96.5% were recorded postdose 3 in the Hib-MenC group. No differences in reactogenicity were seen between the 2 study groups.


CONCLUSIONS
Coadministration of a Hib-MenC conjugate vaccine with DTPa-HBV-IPV is well tolerated and immunogenic, and does not impair the immune response to any of the coadministered antigens.
Tejedor
Juan C
JC
Móstoles Hospital, Madrid, Spain.
Moro
Manuel
M
Ruiz-Contreras
Jesús
J
Castro
Javier
J
Gómez-Campderá
José Antonio
JA
Navarro
María Luisa
ML
Merino
José Manuel
JM
Martín-Ancel
Ana
A
Roca
Joan
J
García-Del-Rí
Manuel
M
Jurado
Antonio
A
Díez-Delgado
Francisco Javier
FJ
Omeñaca
Félix
F
García-Sicilia
José
J
Boceta
Reyes
R
García-Corbeira
Pilar
P
Collard
Alix
A
Boutriau
Dominique
D
Schuerman
Lode
L
Jacquet
Jeanne-Marie
JM
D016667:Bacterial Capsules; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D017325:Hepatitis B Vaccines; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
C451839:DTPa-HBV-IPV combined vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D017325:Hepatitis B Vaccines; D022401:Meningococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D011135:Polysaccharides, Bacterial; D017778:Vaccines, Combined