PMID- 22327493
OWN - NLM
STAT- MEDLINE
DCOM- 20130227
LR  - 20211021
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 8
IP  - 3
DP  - 2012 Mar
TI  - The safety profile of Haemophilus influenzae type b-Neisseria meningitidis 
      serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY).
PG  - 304-11
LID - 10.4161/hv.18752 [doi]
AB  - 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).
FAU - Rinderknecht, Stephen
AU  - Rinderknecht S
AD  - Iowa Health Physicians, Waukee, IA, USA. SBRinder@ihs.org
FAU - Bryant, Kristina
AU  - Bryant K
FAU - Nolan, Terry
AU  - Nolan T
FAU - Pavia-Ruz, Noris
AU  - Pavia-Ruz N
FAU - Doniz, Carlos Aranza
AU  - Doniz CA
FAU - Weber, Miguel Angel Rodriguez
AU  - Weber MA
FAU - Cohen, Christopher
AU  - Cohen C
FAU - Aris, Emmanuel
AU  - Aris E
FAU - Mesaros, Narcisa
AU  - Mesaros N
FAU - Miller, Jacqueline M
AU  - Miller JM
LA  - eng
SI  - ClinicalTrials.gov/NCT00289783
SI  - ClinicalTrials.gov/NCT00345579
SI  - ClinicalTrials.gov/NCT00345683
PT  - Comparative Study
PT  - Journal Article
DEP - 20120213
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hib-MenCY-TT vaccine)
RN  - 0 (Tetanus Toxoid)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Haemophilus Vaccines/*administration & dosage/*adverse effects
MH  - Humans
MH  - Incidence
MH  - Infant
MH  - Tetanus Toxoid/*administration & dosage/*adverse effects
MH  - Vaccines, Conjugate/administration & dosage/adverse effects
PMC - PMC3426078
EDAT- 2012/02/14 06:00
MHDA- 2013/02/28 06:00
PMCR- 2012/03/01
CRDT- 2012/02/14 06:00
PHST- 2012/02/14 06:00 [entrez]
PHST- 2012/02/14 06:00 [pubmed]
PHST- 2013/02/28 06:00 [medline]
PHST- 2012/03/01 00:00 [pmc-release]
AID - 18752 [pii]
AID - 2011HV0188R [pii]
AID - 10.4161/hv.18752 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 
      13.