Abstract
Hib-primed but MenC-naive toddlers (N = 433) were randomized to receive 1 dose of Hib-MenC-TT or separate Hib-TT and MenC-CRM197 vaccines. One month later, noninferiority was demonstrated for serum bactericidal anti-MenC antibodies (rSBA) and Hib antipolyribosylribitol phosphate (PRP) antibodies; >99% in both groups had rSBA titer ≥ 8 or anti-PRP concentration ≥ 0.15 μg/mL. After 12 months, rSBA titer ≥ 8 persisted in 86.7% and 76.4%, and anti-PRP concentration ≥ 0.15 μg/mL persisted in 98.8% and 100% of children, respectively.
Trial registration:
ClinicalTrials.gov NCT00326118.
Publication types
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Comparative Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Antibodies, Bacterial / blood
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Blood Bactericidal Activity
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Haemophilus Vaccines / administration & dosage
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Haemophilus Vaccines / immunology*
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Haemophilus influenzae type b / immunology*
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Humans
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Immunization, Secondary / methods*
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Infant
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Meningococcal Vaccines / administration & dosage
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Meningococcal Vaccines / immunology*
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Neisseria meningitidis, Serogroup C / immunology*
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Tetanus Toxoid / administration & dosage
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Tetanus Toxoid / immunology*
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Time Factors
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Vaccines, Combined / administration & dosage
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Vaccines, Combined / immunology
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Vaccines, Conjugate / administration & dosage
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Vaccines, Conjugate / immunology
Substances
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Antibodies, Bacterial
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Haemophilus Vaccines
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Meningococcal Vaccines
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Tetanus Toxoid
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Vaccines, Combined
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Vaccines, Conjugate
Associated data
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ClinicalTrials.gov/NCT00326118