The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY).
The safety profile of HibMenCY was compared with licensed Hib conjugate vaccines in a pooled analysis that included more than 8,500 subjects who were administered a four-dose series of HibMenCY or commercially available Hib vaccines at 2, 4, 6 and 12-15 mo of age in two primary vaccination and two fourth dose phase 3 studies. In all studies, HibMenCY or Hib vaccine was co-administered with age-appropriate, routinely recommended vaccines. In one primary and one fourth dose study (n = 4180), local and general symptoms were solicited using diary cards for 4 d after each dose. Serious adverse events (SAEs) and the occurrence of adverse events (AEs) indicating new onset of chronic disease (NOCD), rash, and conditions prompting Emergency Room (ER) visits were reported from dose 1 until 6 mo after dose 4. The incidences of solicited local and general symptoms were similar following HibMenCY and commercially available Hib vaccines. For some solicited symptoms (pain at the injection site and irritability), rates were lower in the HibMenCY group compared with the Hib control group (p value < 0.05). There were no statistically significant differences between groups in the incidences of SAEs, NOCDs, rash, or AEs leading to ER visits, with the exceptions of anemia and viral gastroenteritis, which occurred significantly less frequently in those receiving HibMenCY than those receiving commercially available Hib vaccines. In this pooled safety analysis, the safety profile of HibMenCY was similar to the safety profile of licensed monovalent Hib vaccines, despite the addition of meningococcal antigens. These studies are registered at www.clinicaltrials.gov NCT00345579 (primary vaccination study), NCT00345683 (fourth dose vaccination study) and NCT00289783 (primary and fourth dose vaccination studies).
Iowa Health Physicians, Waukee, IA, USA. SBRinder@ihs.org
Stephen
S
Rinderknecht
Kristina
K
Bryant
Terry
T
Nolan
Noris
N
Pavia-Ruz
Carlos Aranza
CA
Doniz
Miguel Angel Rodriguez
MA
Weber
Christopher
C
Cohen
Emmanuel
E
Aris
Narcisa
N
Mesaros
Jacqueline M
JM
Miller
D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D007223:Infant; D013745:Tetanus Toxoid / Q000008:administration & dosage* / Q000009:adverse effects*; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects
D018073:Haemophilus Vaccines; C527605:Hib-MenCY-TT vaccine; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate