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Randomized Trial to Assess Immunogenicity and Safety of Haemophilus influenzae Type b and Neisseria meningitidis Serogroups C and YTetanus Toxoid Conjugate Vaccine in Infants

Marchant, Colin D. MD*; Miller, Jacqueline M. MD†‡; Marshall, Gary S. MD§; Blatter, Mark MD¶; Aris, Emmanuel PhD†‡; Friedland, Leonard R. MD†‡; Boutriau, Dominique MD†‡; for the HibMenCY-TT 005 Study Group

Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e3181c3ce88
Original Studies
Abstract

Background: Study assessed the immunogenicity and safety of an investigational Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y–tetanus toxoid conjugate vaccine (HibMenCY-TT) in infants.

Methods: In a single-blinded, controlled study, 609 infants were randomized 1:1 to receive primary vaccination (2, 4, and 6 months) with either HibMenCY-TT or monovalent Haemophilus influenzae type b tetanus toxoid conjugate vaccine (Hib-TT), co-administered with combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus vaccine and 7-valent pneumococcal conjugate vaccine. A second control group of 3- to 5-year-old children received a single dose of licensed meningococcal ACWY polysaccharide vaccine (MPSV4). Immunogenicity was measured before and 1 month after dose 3/MPSV4 using human (hSBA) and rabbit complement bactericidal assays (rSBA) and enzyme-linked immunosorbent assay assays for IgG antibodies to MenC and MenY polysaccharides. Anti-polyribosylribitol phosphate antibody concentrations were measured 1 month after the third dose. Safety was also assessed.

Results: One month after primary vaccination statistically significantly more HibMenCY-TT than Hib-TT vaccines had anti-PRP antibody concentrations ≥1.0 μg/mL (93.5% vs. 85.8%). The percentage of HibMenCY-TT recipients with hSBA titers ≥1:8 (MenC: 95.9%, MenY: 89.4%) was statistically significantly higher than for MPSV4 recipients (MenC: 30.2%, MenY: 47.5%). The percentage of subjects reporting any severe (grade 3) symptom within 4 days of each vaccination was: 11.5% (HibMenCY-TT) and 24.8% (Hib-TT) (group difference, 13.27%, 95% CI: [7.22;19.29], P < 0.001).

Conclusion: The investigational HibMenCY-TT vaccine was well tolerated and immunogenic in infants, induced Hib immune responses that were comparable to licensed Hib-TT vaccine, and induced high levels of bactericidal antibodies against N. meningitidis serogroups C and Y.

Author Information

From the *Boston University Medical Center, Boston, MA; †GlaxoSmithKline Biologicals, United States; ‡GlaxoSmithKline Biologicals, Rixensart, Belgium; §School of Medicine, University of Louisville, Louisville, KY; and ¶Primary Physicians Research, Pittsburgh, PA.

Accepted for publication September 30, 2009.

Supported by GlaxoSmithKline Biologicals in all stages of the study conduct and analysis and also all costs associated with the development and the publishing of the present manuscript.

Prevnar is a registered trademark of Wyeth. ActHIB and Menomune are registered trademarks of Sanofi Pasteur. Pediarix is a trademark of the GlaxoSmithKline group of companies.

The clinical trial is registered at: clinical trials.gov NCT00129129.

Address for correspondence: Colin Marchant, MD, Boston University Medical Center, Boston, MA 02118. E-mail: cdmarcha@bu.edu.

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© 2010 Lippincott Williams & Wilkins, Inc.