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Immunogenicity and Reactogenicity of a Booster Dose of a Novel Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C-Tetanus Toxoid Conjugate Vaccine Given to Toddlers of 13–14 Months of Age With Antibody Persistence Up to 31 Months of Age

Tejedor, Juan C. MD*; Moro, Manuel MD; Merino, José Manuel MD; Gómez-Campderá, José Antonio MD§; García-del-Rio, Manuel MD; Jurado, Antonio MD; Díez-Delgado, Francisco Javier MD; Omeñaca, Félix MD#; García-Sicilia, José MD#; Ruiz-Contreras, Jesús MD**; Martin-Ancel, Ana MD††; Roca, Joan MD‡‡; Boceta, Reyes BSc§§; García-Corbeira, Pilar MD§§; Maechler, Gudrun MD§§; Boutriau, Dominique MD§§for the Spanish 102547 Study Group

The Pediatric Infectious Disease Journal: July 2008 - Volume 27 - Issue 7 - p 579-588
doi: 10.1097/INF.0b013e31816b4561
Original Studies

Background: A combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) may be a convenient alternative to separate Hib and MenC conjugate vaccines.

Methods: Healthy infants randomized in a previous study for priming at 2, 4, and 6 months: Hib-MenC-TT primed group, 3 doses of Hib-MenC-TT + DTPa-HBV-IPV (N = 87); MenC-TT primed group, 2 doses of MenC-TT (NeisVac-C™; Baxter Healthcare SA, Zuürich, Switzerland) + 3 doses of DTPa/Hib containing vaccines (N = 178); MenC-CRM primed group, 3 doses of MenC-CRM197(Meningitec™; Wyeth Corporation Delaware, Madison, NJ) + DTPa-HBV-IPV/Hib (N = 93). At 13-14 months of age, Hib-MenC-TT and MenC-TT primed groups received a Hib-MenC-TT booster dose and the MenC-CRM primed group a booster dose of DTPa-HBV-IPV/Hib. Blood samples were taken before and at 1 and 18 months postbooster.

Results: Before the booster dose, persistence of anti-polyribosyl ribitol phosphate (PRP) antibody concentration ≥0.15 μg/mL in the Hib-MenC-TT (96.4%) and MenC-TT (96.1%) primed groups and of MenC bactericidal titers ≥1:8 in the Hib-MenC-TT primed group (96.3%) was statistically significantly higher than in the MenC-CRM primed group (86.4% and 85.4%, respectively). One month after the Hib-MenC-TT booster, 99.2% subjects in the Hib-MenC-TT primed + MenC-TT primed pooled groups had anti-PRP levels ≥1 μg/mL, and 99.6% had SBA-MenC titers ≥1:128. The Hib-MenC-TT booster tended to be less reactogenic than the DTPa-HBV-IPV/Hib control and no serious adverse events related to vaccination were reported. Eighteen months after boosting with Hib-MenC-TT, SBA-MenC titers ≥1:8 persisted in 92.7% subjects and anti-PRP ≥0.15 μg/mL persisted in 99.4%.

Conclusions: Primary immunization with 3 doses of Hib-MenC-TT coadministered with DTPa-HBV-IPV induced antibodies that persisted up to the second year of life. The Hib-MenC-TT booster administered to primed toddlers induced robust and persistent antibody responses to both the Hib and MenC components and had an acceptable safety profile.

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

Accepted for publication January 29, 2008.

These studies (study numbers 102547 and 106672; NCT00323050 and 00322335) were supported by GlaxoSmithKline Biologicals, Rixensart, Belgium.

Conflict of interest: Drs. Garcia-del-Rio, Jurado, Martin-Ancel and Roca declare they have no conflict of interest. Drs. Ruiz-Contreras, Gomez-Campdera, Garcia-Sicilia, Tejedor, Merino declare they received consulting fees, honoraria/travel grants from GlaxoSmithKline Biologicals in the past 3 years. Drs. Diez Delgado, Moro, and Omenaca declare they received honoraria/travel grants from GlaxoSmithKline Biologicals in the past 3 years. Drs. Maechler, Garcia-Corbeira, Boceta, Boutriau, declare they are employed by the GlaxoSmithKline group of companies and have stock ownership.

Address for correspondence: Dominique Boutriau, MD, GlaxoSmithKline Biologicals, Rue du l'Institut, 89, 1330 Rixensart, Belgium. E-mail:

© 2008 Lippincott Williams & Wilkins, Inc.