PMID- 29902133
OWN - NLM
STAT- MEDLINE
DCOM- 20190617
LR  - 20200306
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 14
IP  - 11
DP  - 2018
TI  - Immunogenicity and safety of a second dose of a measles-mumps-rubella vaccine 
      administered to healthy participants 7 years of age or older: A phase III, 
      randomized study.
PG  - 2624-2631
LID - 10.1080/21645515.2018.1489186 [doi]
AB  - The introduction of vaccination programs against measles, mumps, and rubella 
      (MMR) led to significant global reduction in morbidity and mortality from these 
      diseases. The currently recommended MMR vaccination schedule in the United States 
      of America comprises 2 vaccine doses typically administered at 12-15 months and 
      4-6 years, respectively. Considering recent outbreaks in the USA, catch-up 
      vaccination with an additional dose of MMR vaccine could contribute to outbreak 
      control and community protection. This phase III, observer-blind, randomized 
      controlled trial (NCT02058563) assessed the immunogenicity and safety of a dose 
      of the MMR-RIT vaccine (Priorix, GSK) compared to MMR II vaccine (control; 
      M-M-R II, Merck&Co Inc.) in >/=7-year-olds who had received >/=1 previous dose of MMR 
      vaccine. We assessed anti-measles, anti-mumps, and anti-rubella antibody 
      geometric mean concentrations (GMCs; primary endpoint) and seroresponse rates 
      (SRRs) at day 42 post-vaccination. Solicited, unsolicited, and serious adverse 
      events (AEs) were recorded. The according-to-protocol cohort for immunogenicity 
      included 869 participants (MMR-RIT: N = 433; MMR II: N = 436). We observed 
      anti-measles, anti-mumps, and anti-rubella antibody GMCs of 1790.2 mIU/mL, 
      113.5 EU/mL, and 76.1 IU/mL, respectively, and SRRs of 98.8%, 98.4%, and 99.5%, 
      respectively, after a dose of MMR-RIT; non-inferiority compared to MMR II was 
      demonstrated. Both vaccines showed comparable reactogenicity profiles; the most 
      common solicited AEs were injection site redness and pain, and fever (MMR-RIT: 
      12.2%, 11.8%, and 3.0%; MMR II: 11.7%, 11.5%, and 5.2%, respectively). The dose 
      of MMR-RIT induced robust immune responses that were not inferior to those of 
      MMR II, and was well tolerated.
FAU - Abu-Elyazeed, Remon
AU  - Abu-Elyazeed R
AD  - a GSK , Philadelphia , PA , USA.
FAU - Jennings, William
AU  - Jennings W
AD  - b Radiant Research , San Antonio , TX , USA.
FAU - Severance, Randall
AU  - Severance R
AUID- ORCID: 0000-0003-1580-5410
AD  - c Radiant Research , Chandler , AZ , USA.
FAU - Noss, Michael
AU  - Noss M
AD  - d Radiant Research , Cincinnati , OH , USA.
FAU - Caplanusi, Adrian
AU  - Caplanusi A
AD  - e GSK , Wavre , Belgium.
FAU - Povey, Michael
AU  - Povey M
AD  - e GSK , Wavre , Belgium.
FAU - Henry, Ouzama
AU  - Henry O
AD  - f GSK , Rockville , MD , USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02058563
PT  - Clinical Trial, Phase III
PT  - Equivalence Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180712
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Viral)
RN  - 0 (Measles-Mumps-Rubella Vaccine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Viral/*blood/immunology
MH  - Child
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Immunization Schedule
MH  - Immunization, Secondary/adverse effects/*methods
MH  - *Immunogenicity, Vaccine
MH  - Injection Site Reaction/epidemiology/immunology
MH  - Male
MH  - Measles/immunology/prevention & control/virology
MH  - Measles-Mumps-Rubella Vaccine/administration & dosage/adverse effects/*immunology
MH  - Mumps/immunology/prevention & control/virology
MH  - Rubella/immunology/prevention & control/virology
MH  - Young Adult
PMC - PMC6314414
OTO - NOTNLM
OT  - immunization schedule
OT  - immunogenicity
OT  - measles-mumps-rubella vaccine
OT  - safety
OT  - second dose
EDAT- 2018/06/15 06:00
MHDA- 2019/06/18 06:00
PMCR- 2018/07/12
CRDT- 2018/06/15 06:00
PHST- 2018/06/15 06:00 [pubmed]
PHST- 2019/06/18 06:00 [medline]
PHST- 2018/06/15 06:00 [entrez]
PHST- 2018/07/12 00:00 [pmc-release]
AID - 1489186 [pii]
AID - 10.1080/21645515.2018.1489186 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2018;14(11):2624-2631. doi: 10.1080/21645515.2018.1489186. 
      Epub 2018 Jul 12.