PMID- 32401600
OWN - NLM
STAT- MEDLINE
DCOM- 20231006
LR  - 20231006
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 16
IP  - 6
DP  - 2020 Jun 2
TI  - Efficacy and safety of a booster dose of the meningococcal A, C, W, Y-tetanus 
      toxoid conjugate vaccine administered 10 years after primary vaccination and 
      long-term persistence of tetanus toxoid conjugate or polysaccharide vaccine.
PG  - 1272-1279
LID - 10.1080/21645515.2020.1744363 [doi]
AB  - A previous phase 3, randomized, multicenter study showed the immunogenicity of a 
      primary vaccination of subjects aged 11 to 17 years with the quadrivalent 
      meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) or the 
      quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS). This extension 
      study evaluated the safety and immunogenicity of a MenACWY-TT booster 10 years 
      after receiving a primary dose of either MenACWY-TT or MenACWY-PS. The primary 
      immunogenicity endpoint was booster response, evaluated using serum bactericidal 
      antibody assays with rabbit complement (rSBA), 1 month postbooster. Safety 
      endpoints included the percentage of subjects experiencing local and general 
      adverse events (AEs) </=4 days after MenACWY-TT booster. Of 229 subjects enrolled, 
      169 and 58 in the MenACWY-TT and MenACWY-PS groups, respectively, completed the 
      booster phase. The 1 month postbooster response for each serogroup ranged from 
      81.5% to 95.7% for MenACWY-TT and 66.7% to 94.1% for MenACWY-PS. Similar 
      percentages of MenACWY-TT and MenACWY-PS recipients had a booster response to 
      serogroups A, W, and Y, whereas more MenACWY-TT recipients than MenACWY-PS 
      recipients had a booster response to serogroup C. For the MenACWY-TT and 
      MenACWY-PS groups, respectively, the MenACWY-TT booster elicited rSBA titers >/=1:8 
      in 100% and >/=98.0% of subjects across all serogroups; 100% and >/=96.1% of all 
      subjects had titers >/=1:128. No new safety signals were observed during the 
      booster phase. In conclusion, a MenACWY-TT booster dose after receiving either a 
      primary dose of MenACWY-TT or MenACWY-PS elicited robust immune responses and was 
      well tolerated. Functional antibody responses last up to 10 years after primary 
      MenACWY-TT vaccination.
FAU - Quiambao, Beatriz
AU  - Quiambao B
AD  - Clinical Research Division, Research Institute for Tropical Medicine , Alabang, 
      Muntinlupa City, Philippines.
FAU - Peyrani, Paula
AU  - Peyrani P
AD  - Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, 
      USA.
FAU - Li, Ping
AU  - Li P
AD  - Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, 
      USA.
FAU - Cutler, Mark W
AU  - Cutler MW
AD  - Pfizer Vaccine Research and Development, Pfizer Inc , Pearl River, NY, USA.
FAU - Van Der Wielen, Marie
AU  - Van Der Wielen M
AD  - Vaccines R & D, GlaxoSmithKline , Wavre, Belgium.
FAU - Perez, John L
AU  - Perez JL
AD  - Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, 
      USA.
FAU - Webber, Chris
AU  - Webber C
AD  - Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Hurley, UK.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200513
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Polysaccharides)
RN  - 0 (Tetanus Toxoid)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Antibodies, Bacterial
MH  - *Meningococcal Infections/prevention & control
MH  - *Meningococcal Vaccines/adverse effects
MH  - Polysaccharides
MH  - Tetanus Toxoid/adverse effects
MH  - Vaccination
MH  - Vaccines, Conjugate/adverse effects
MH  - Humans
PMC - PMC7482828
OTO - NOTNLM
OT  - Antibody
OT  - MenACWY-TT
OT  - booster
OT  - immunogenicity
OT  - persistence
OT  - safety
EDAT- 2020/05/14 06:00
MHDA- 2021/06/22 06:00
PMCR- 2020/05/13
CRDT- 2020/05/14 06:00
PHST- 2020/05/14 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/05/14 06:00 [entrez]
PHST- 2020/05/13 00:00 [pmc-release]
AID - 1744363 [pii]
AID - 10.1080/21645515.2020.1744363 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2020 Jun 2;16(6):1272-1279. doi: 
      10.1080/21645515.2020.1744363. Epub 2020 May 13.