PMID- 25483566
OWN - NLM
STAT- MEDLINE
DCOM- 20151130
LR  - 20150310
IS  - 1708-8305 (Electronic)
IS  - 1195-1982 (Linking)
VI  - 22
IP  - 2
DP  - 2015 Mar-Apr
TI  - Immunogenicity and safety of concomitant administration of a combined hepatitis 
      A/B vaccine and a quadrivalent meningococcal conjugate vaccine in healthy adults.
PG  - 105-14
LID - 10.1111/jtm.12180 [doi]
AB  - BACKGROUND: This phase 3b randomized, open-label study evaluated the 
      immunogenicity and safety of coadministration of a hepatitis A and/or B vaccine 
      with a quadrivalent oligosaccharide meningococcal CRM197 -conjugate vaccine 
      (MenACWY-CRM), in the context of an accelerated hepatitis A and/or B immunization 
      schedule. METHODS: A total of 252 healthy adult subjects were randomized to three 
      groups to receive hepatitis A/B only (HepA/B), hepatitis A/B coadministered with 
      MenACWY-CRM (HepA/B+MenACWY-CRM), or MenACWY-CRM only (MenACWY-CRM). Hepatitis A 
      and/or B vaccination was administered in the form of a single booster dose or a 
      primary three-dose series, depending on the hepatitis A and/or B vaccination 
      history of subjects. Antibody responses to hepatitis A/B vaccination were 
      assessed 1 month following the last hepatitis A and/or B dose. Serum bactericidal 
      activity with human complement (hSBA) against meningococcal serogroups A, C, 
      W-135, and Y was assessed 1 month post-MenACWY-CRM vaccination. Safety was 
      monitored throughout the study. RESULTS: At 1 month following the final hepatitis 
      A and/or B vaccination, concomitant administration of hepatitis A/B and 
      MenACWY-CRM was non-inferior to administration of hepatitis A/B alone in terms of 
      geometric mean concentrations of antibodies against the hepatitis A and B 
      antigens. One month post-MenACWY-CRM vaccination, the percentages of subjects 
      achieving hSBA titers >/=8 for serogroups A, C, W-135, and Y in the 
      HepA/B+MenACWY-CRM group (76, 87, 99, and 94%, respectively) were comparable to 
      those in the MenACWY-CRM group (67, 82, 96, and 88%, respectively). The 
      percentages of subjects reporting adverse events (AEs) were similar across study 
      groups and a majority of the reported AEs were mild to moderate in nature. There 
      were no study vaccine-related serious AEs. CONCLUSIONS: MenACWY-CRM can be 
      administered concomitantly with a hepatitis A and/or B vaccine in the context of 
      an accelerated hepatitis A and/or B immunization schedule without increasing 
      safety concerns or compromising the immune responses to any of the vaccine 
      antigens. [NCT01453348].
CI  - (c) 2014 International Society of Travel Medicine.
FAU - Alberer, Martin
AU  - Alberer M
AD  - Department of Infectious Diseases and Tropical Medicine, University of Munich, 
      Munich, Germany.
FAU - Burchard, Gerd
AU  - Burchard G
FAU - Jelinek, Tomas
AU  - Jelinek T
FAU - Reisinger, Emil C
AU  - Reisinger EC
FAU - Meyer, Seetha
AU  - Meyer S
FAU - Forleo-Neto, Eduardo
AU  - Forleo-Neto E
FAU - Dagnew, Alemnew F
AU  - Dagnew AF
FAU - Arora, Ashwani Kumar
AU  - Arora AK
LA  - eng
SI  - ClinicalTrials.gov/NCT01453348
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20141207
PL  - England
TA  - J Travel Med
JT  - Journal of travel medicine
JID - 9434456
RN  - 0 (Hepatitis A Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (MenACWY)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Germany
MH  - Hepatitis A/prevention & control
MH  - Hepatitis A Vaccines/administration & dosage/adverse effects
MH  - Hepatitis B/prevention & control
MH  - Hepatitis B Vaccines/administration & dosage
MH  - Humans
MH  - Immunization Schedule
MH  - Male
MH  - Meningococcal Infections/*prevention & control
MH  - Meningococcal Vaccines/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Vaccines, Conjugate/*administration & dosage/adverse effects
MH  - Young Adult
EDAT- 2014/12/09 06:00
MHDA- 2015/12/15 06:00
CRDT- 2014/12/09 06:00
PHST- 2014/05/14 00:00 [received]
PHST- 2014/10/02 00:00 [revised]
PHST- 2014/10/03 00:00 [accepted]
PHST- 2014/12/09 06:00 [entrez]
PHST- 2014/12/09 06:00 [pubmed]
PHST- 2015/12/15 06:00 [medline]
AID - 10.1111/jtm.12180 [doi]
PST - ppublish
SO  - J Travel Med. 2015 Mar-Apr;22(2):105-14. doi: 10.1111/jtm.12180. Epub 2014 Dec 7.