The safety profile ofHaemophilus influenzaetype b–Neisseria meningitidisserogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY)

Abstract

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)

Immunogenicity and safety of the Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine co-administered with human rotavirus, hepatitis A and 13-valent pneumococcal conjugate vaccines: results from a phase III, randomized, multicenter study in infants

“…The safety profile of Hib-MenCY-TT in our study was similar to that observed in previous studies which evaluated its co-administration with the routine recommended vaccines (DTaP-HBV-IPV, 7-valent pneumococcal conjugate vaccine, mumpsmeasles-rubella vaccine, and varicella virus vaccine). 17 The safety profiles of HRV, PCV13 and HAV were also similar when coadministered with Hib-MenCY-TT or Hib-OMP, which is also consistent with the results obtained when other routine childhood vaccines were co-administered with Hib-MenCY-TT. 11 A study limitation was the high drop-out rate observed during the study period as nearly one fourth of participants did not complete the study and nearly half of participants were excluded from the primary ATP immunogenicity cohort, because we had not planned to bleed most of these participants.…”

MenHibrix

“…21,29 Solicited local (injection site pain, redness, and swelling) and general (fever ≥38°C, drowsiness, irritability, and loss of appetite) symptoms occurred at similar rates in both groups, with the exceptions of pain at the injection site and irritability, which were reported at significantly (P < .05) lower rates after vaccination with Hib-MenCY-TT than Hib. 28 Similar rates were observed for SAEs, new onset of chronic disease, rash, and adverse events prompting emergency room visits after vaccination with either Hib-MenCY-TT or Hib vaccines. Only anemia was reported more frequently in the Hib group than the Hib-MenCY-TT group (0.1% vs 0.0%, respectively; P = .03).…”

“…21 Safety was also evaluated in a pooled analysis of more than 8500 infants who received a 4-dose series of either Hib-MenCY-TT (n = 6414) or Hib vaccines (n = 2157), in addition to routine age-appropriate vaccines. 28 The analysis combined 2 primary vaccination and 2 dose 4 studies. 21,29 Solicited local (injection site pain, redness, and swelling) and general (fever ≥38°C, drowsiness, irritability, and loss of appetite) symptoms occurred at similar rates in both groups, with the exceptions of pain at the injection site and irritability, which were reported at significantly (P < .05) lower rates after vaccination with Hib-MenCY-TT than Hib.…”

A Licensed Combined Haemophilus influenzae Type b-Serogroups C and Y Meningococcal Conjugate Vaccine

“…Despite the addition of MenC and Y antigens, the reactogenicity of HibMenCY-TT does not differ from that associated with administration of Hib-TT vaccine [ 33 , 36 , 37 ]. A pooled safety analysis that included more than 8,500 participants from two primary vaccination and two-fourth dose phase III clinical trials found the incidence of serious adverse events, adverse events and solicited local and general systemic symptoms were similar following HibMenCY-TT and licensed Hib vaccines [ 39 ]. Rates of pain at the injection site and irritability were significantly lower following HibMenCY-TT than commercially available Hib vaccines [ 39 ].…”