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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

Tejedor, Juan C. MD*; Moro, Manuel MD; Ruiz-Contreras, Jesús MD; Castro, Javier MD; Gómez-Campderá, José Antonio MD§; Navarro, María Luisa MD§; Merino, José Manuel MD; Martín-Ancel, Ana MD; Roca, Joan MD#; García-del-Rí, Manuel MD**; Jurado, Antonio MD**; Díez-Delgado, Francisco Javier MD††; Omeñaca, Félix MD‡‡; García-Sicilia, José MD‡‡; Boceta, Reyes BSc§§; García-Corbeira, Pilar MD§§; Collard, Alix PhD§§; Boutriau, Dominique MD§§; Schuerman, Lode MD§§; Jacquet, Jeanne-Marie PhD§§for the Spanish DTPa-HBV-IPV-097 Study Group

The Pediatric Infectious Disease Journal: January 2007 - Volume 26 - Issue 1 - p 1-7
doi: 10.1097/01.inf.0000247070.60063.09
Original Studies

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 (≥0.15 μg/mL) and SBA-MenC titers (≥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 μg/mL and 2467.1 μg/mL, respectively) than in the control group (3.8 μg/mL and 1833.7 μg/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 ≥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.

From the *Móstoles Hospital, Madrid, Spain; †Clínico San Carlos Hospital, Madrid, Spain; ‡12 de Octubre Hospital, Madrid, Spain; §Gregorio Marañón Hospital, Madrid, Spain; ∥General Yagüe Hospital, Burgos, Spain; ¶Alcorcón Hospital, Madrid, Spain; #Sant Joan de Deu Hospital, Barcelona, Spain; **Carlos Haya Hospital, Málaga, Spain; ††Torrecárdenas Hospital, Almería, Spain; ‡‡La Paz Hospital, Madrid, Spain; and §§GlaxoSmithKline Biologicals, Spain and Belgium.

Accepted for publication September 14, 2006.

This study was funded by GlaxoSmithKline Biologicals, Rixensart, Belgium.

Address for correspondence: Dr Pilar García-Corbeira, Medical Department, GlaxoSmithKline, c/Severo Ochoa, 2, 28760 Tres Cantos, Madrid. E-mail: Pilar.garcia-corbeira@gsk.com.

© 2007 Lippincott Williams & Wilkins, Inc.